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| ID | Type | Description | Link |
|---|---|---|---|
| 10037 | Registry Identifier | DAIDS ES | |
| IMPAACT P1020A | |||
| PACTG P1020-A | |||
| ACTG P1020-A |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| International Maternal Pediatric Adolescent AIDS Clinical Trials Group | NETWORK |
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The purpose of this study was to find a safe and tolerable dose of the protease inhibitor (PI) atazanavir (ATV), with or without a low-dose boost of the PI ritonavir (RTV), when taken with other anti-HIV drugs in HIV infected infants, children, and adolescents.
Advancements in anti-HIV drugs for HIV infected children and adolescents have been hard to make, in part because these patients often do not take the drugs as prescribed. ATV may be a better option because it is available in the form of powder which children and adolescents may be more willing to take regularly. Using a low dose of RTV as a boosting agent for ATV may also increase the chances of virologic response of highly active antiretroviral treatment (HAART)-experienced patients. This study aimed to find safe and tolerable doses of ATV with or without low-dose RTV boost in infants, children, and adolescents. For this study, participants were enrolled in the United States and South Africa.
Advancements in HAART for HIV-infected children and adolescents are hindered by patient nonadherence. The availability of a powder formulation and the once-daily dosing schedule make ATV an attractive agent for improved adherence in pediatric treatment regimens. This study was designed to provide pharmacokinetic (PK) data to guide dosing recommendations for ATV, when given concurrently with or without low-dose RTV boost, in infants, children, and adolescents. During the study, the safety and tolerance of ATV (with or without low-dose RTV) were closely monitored, and virologic efficacy data were obtained.
There were two parts to this study. Step I took place in the United States and South Africa, and were further divided into two sets of groups, Parts A and B. Part A participants received ATV only and Part B participants received ATV with low-dose RTV boost. All participants received ATV once a day with 2 other antiretroviral drugs (not provided by the study). In Part B only, participants received ATV with a low dose of RTV. Participants were placed into 1 of 8 groups (Groups 1 to 4 for Part A; Groups 5 to 8 for Part B) with respect to age and study drug formulation. Participants in Groups 1 and 5 were infants between ages 3 months and 1 day (91 days) and 2 years (less than or exactly 730 days) and took ATV in powder form. Participants in Groups 2, 3, 6, and 7 were children between 2 years and 1 day (731 days) old and 13 years old. Groups 2 and 6 received ATV in powder form, while Groups 3 and 7 received the capsule form. Patients in Groups 4 and 8 were adolescents between 13 years and 1 day old and 21 years old (not including the 22nd birthday) and took ATV in capsule form. As of 01/02/2008 a new group, 5A was opened for enrollment. Participants in Group 5A were between 3 months and 6 months old and took ATV in powder form plus a low-dose RTV booster.
For each group, enrollment started with five participants per group. All participants were evaluated for PK and safety criteria, adjusting the dose of ATV until one was found that passes both sets of criteria. Then five additional participants were enrolled, with enrollment continuing for each group once all participants within that group meet the PK criteria. For groups receiving RTV (Groups 5 to 8), additional criteria must be met for each dose of ATV studied. In addition to the PK and safety evaluations, 24-hour post-dose concentrations (Cmin) were monitored in the first 10 participants enrolled for a dose of ATV before more participants were enrolled and studied at that same dose. Note that in Protocol Version 5.0, South African (S.A.) sites were allowed to enroll patients in study groups 3,4,5,6,7,8. As a result, the study design has been modified to further stratify study groups 3, 4, 5, 6, 7, 8 (at the final recommended dose), by country, i.e., U.S.A. versus S.A., such that 10 evaluable study subjects will be accrued in parallel to each study group-country cohort.
Clinic visits will be every 4 weeks through Week 48, then every 8 weeks until the last participant to enroll in the study has reached Week 96 of his/her treatment. If, after 56 weeks, a participant has a toxic reaction to a nucleoside/tide reverse transcriptase inhibitor (NRTI) in their medication regimen, the regimen may be changed to a different NRTI. At every visit, participants will undergo a complete medical history and physical exam, cardiac conduction evaluation, and urine and blood collection. Participants of childbearing age will have a pregnancy test performed at each visit.
Step II will only be open to South African subjects who are virologically responding to treatment when the last enrollee into either part of Step I (Part A or Part B) has completed 96 weeks of treatment (end of Step I) . All such participants will be given ATV in capsule form at the same dose they received at the end of Step I, as well as the other antiretrovirals they were receiving during Step I. Step II will continue until ATV is approved in South Africa and readily available by individual prescription, and participants will have a study visit every 12 weeks.
Note that the following ATV doses were independently evaluated for each group during the dose-finding stage based on the description above: Group 1 ATV Powder (310mg/m^2, 620mg/m^2); Group 2 ATV Powder (310mg/m^2, 620mg/m^2); Group 3 ATV Capsule (310mg/m^2, 415mg/m^2, 520mg/m^2); Group 4 ATV Capsule (310mg/m^2, 520mg/m^2, 620mg/m^2); Group 5 ATV Powder + RTV (310mg/m^2); Group 6 ATV Powder +RTV (310mg/m^2); Group 7 ATV Capsule + RTV (310mg/m^2, 205mg/m^2); Group 8 ATV Capsule + RTV (310mg/m^2, 205mg/m^2); Group 5A ATV Powder + RTV (310mg/m^2). All these dosing groups are presented in Participant Flow groups to show the total number of participants enrolled, but only the participants enrolled at the final group doses are presented in the subsequent results.
The following groups satisfied the safety and PK guidelines specified in the protocol: Groups 3,4,6,7,8. Groups 5 and 5A did not satisfy the protocol-defined pharmacokinetic criteria. There was considerable inter-subject variability in systemic exposures in this age group, such that a dose escalation to 415mg/m^2 may have resulted in ATV exposures greater than 90,000 ng*hr/mL in some children. Thus, a further dose increase in Groups 5 and 5A was not attempted.
These are the final dose for each group: Groups 1 and 2 (Final dose was not established); Group 3 ATV Capsule (520mg/m^2); Group 4 ATV Capsule (620mg/m^2); Group 5 ATV Powder (310mg/m^2) + RTV; Group 6 ATV Powder (310mg/m^2) +RTV; Group 7 ATV Capsule (205mg/m^2) + RTV; Group 8 ATV Capsule (205mg/m^2) + RTV; Group 5A ATV Powder (310mg/m^2) + RTV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Step I: Group 1 | Experimental | Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs. ATV Dose Tested: 310 mg/m^2, 620 mg/m^2; Final Dose: Not Established |
|
| Step I: Group 2 | Experimental | Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs. ATV Dose Tested: 310 mg/m^2, 620 mg/m^2; Final Dose: Not Established |
|
| Step I: Group 3 | Experimental | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV Dose Tested: 310 mg/m^2, 415 mg/m2, 520 mg/m^2; Final Dose: 520 mg/m^2 |
|
| Step I: Group 4 | Experimental | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV Dose Tested: 310 mg/m^2, 520 mg/m^2, 620 mg/m^2; Final Dose: 620 mg/m^2 |
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| Step I: Group 5 | Experimental | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV Dose Tested: 310 mg/m^2; Final Dose: 310 mg/m^2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATV | Drug | Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Safety Endpoint of Interest Attributed to ATV | Total Bilirubin >= 5.1xULN, ECG Events and Other Grade 3+ toxicities attributed to study treatment. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) Toxicity Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study team. | From study entry up to week 96 |
| Number of Participants Who Died | From study entry up to week 96 | |
| Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC24h) | Pharmacokinetics were determined by non-compartmental analysis and AUC0-24hr calculated by the linear trapezoidal method. | Week 1 (Day 7) Intensive PK-24hr (Pre-Dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
| Pharmacokinetic (PK) Parameter: Minimum Plasma Concentration (C24) | Pharmacokinetics were determined by non-compartmental analysis. C24 determined visually, except in the instance when the patient re-dosed the study medication prior to the 24 hour blood draw or the 24 hour level was not obtained, in which case the C24 was calculated from the elimination rate (ke) and the last measured concentration. | Week 1 (Day 7) Intensive PK-24hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
| Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) | Pharmacokinetics were determined by non-compartmental analysis and Maximum concentration (Cmax) was determined visually. | Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HIV RNA <400 Copies/mL at Week 24 | Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa. |
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Inclusion Criteria for Step I:
Exclusion Criteria for Step I:
Active hepatitis
Presence of an acute serious/invasive infection requiring therapy at the time of enrollment
Hypersensitivity to any component of the formulation of ATV
Chemotherapy for active malignancy
Pregnant or breastfeeding
Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the clinician's opinion, would compromise the outcome of this study
Any laboratory or clinical toxicity greater than Grade 2 at entry
Documented history of cardiac conduction abnormalities or significant cardiac dysfunction
History of undefined syncope that cannot be ruled out as related to cardiac conduction abnormalities
Family history of prolonged QTc-interval syndrome, Brugada syndrome, or right-ventricular (RV) dysplasia
Corrected QTc-Interval greater than 440 msec at screening
Prolonged PR-Interval greater than 0.200 seconds (200 ms) on ECG at screening (study candidates greater than or equal to 13 years of age)
PR-Interval greater than 98th percentile on ECG at screening (study candidates less than 13 years of age)
Cardiac rhythm abnormalities:
Prolonged therapy with intravenous pentamidine for acute Pneumocystis Carinii Pneumonia (PCP) within three months of entry
Inclusion Criteria for Step II:
Exclusion Criteria for Step II:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Rutstein, MD | Children's Hospital of Philadelphia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Pediatric Infectious Diseases CRS | Birmingham | Alabama | 35233 | United States | ||
| Usc La Nichd Crs |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25232777 | Background | Rutstein RM, Samson P, Fenton T, Fletcher CV, Kiser JJ, Mofenson LM, Smith E, Graham B, Mathew M, Aldrovani G; PACTG 1020A Study Team. Long-term safety and efficacy of atazanavir-based therapy in HIV-infected infants, children and adolescents: the Pediatric AIDS Clinical Trials Group Protocol 1020A. Pediatr Infect Dis J. 2015 Feb;34(2):162-7. doi: 10.1097/INF.0000000000000538. | |
| 21610486 |
| Label | URL |
|---|---|
| DAIDS Toxicity Table for Grading Severity of Pediatric (\> 3 mos of age) Adverse Experiences April, 1994. | View source |
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Date of First Enrollment: 16 November 2000; Date of Last Enrollment: 22 December 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: ATV Dose: Powder (310mg/m^2) | Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs. |
| FG001 | Group 1: ATV Dose: Powder (620mg/m^2) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Step I: Group 5a | Experimental | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV Dose Tested: 310 mg/m^2; Final Dose: 310 mg/m^2 |
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| Step I: Group 6 | Experimental | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV Dose Tested: 310 mg/m^2; Final Dose: 310 mg/m^2 |
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| Step I: Group 7 | Experimental | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV Dose Tested: 310 mg/m^2, 205 mg/m^2; Final Dose: 205 mg/m^2 |
|
| Step I: Group 8 | Experimental | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV Dose Tested: 310 mg/m^2, 205 mg/m^2; Final Dose: 205 mg/m^2 |
|
| Ritonavir | Drug | Administered as 100 mg capsules or oral solution. |
|
| Pharmacokinetic (PK) Parameter: Clearance (CL/F) | Pharmacokinetics were determined by non-compartmental analysis and Apparent oral clearance (CL/F) was calculated as ATV dose divided by AUC0-24hr. | Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
| Week 24 |
| Percentage of Participants With HIV RNA <400 Copies/mL at Week 48 | Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa. | Week 48 |
| Percentage of Participants With HIV RNA <400 Copies/mL at Week 96 | Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa. | Week 96 |
| Change in CD4 Count (Cells/mm^3) From Baseline to Week 20 | Baseline, Week 20 |
| Change in CD4 Count (Cells/mm^3) From Baseline to Week 48 | Baseline, Week 48 |
| Change in CD4 Count (Cells/mm^3) From Baseline to Week 96 | Baseline, Week 96 |
| Change in CD4 Percent From Baseline to Week 20 | Baseline, Week 20 |
| Change in CD4 Percent From Baseline to Week 48 | Baseline, Week 48 |
| Change in CD4 Percent From Baseline to Week 96 | Baseline, Week 96 |
| Alhambra |
| California |
| 91803 |
| United States |
| University of California, UC San Diego CRS | La Jolla | California | 92093-0672 | United States |
| Miller Children's Hosp. Long Beach CA NICHD CRS | Long Beach | California | 90806 | United States |
| UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS | Los Angeles | California | 900951752 | United States |
| Univ. of California San Francisco NICHD CRS | San Francisco | California | 94143 | United States |
| Univ. of Colorado Denver NICHD CRS | Aurora | Colorado | 80045 | United States |
| Howard Univ. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20060 | United States |
| South Florida CDTC Ft Lauderdale NICHD CRS | Fort Lauderdale | Florida | 33316 | United States |
| Columbus Regional HealthCare System, The Med. Ctr. | Columbus | Georgia | 31901 | United States |
| Rush Univ. Cook County Hosp. Chicago NICHD CRS | Chicago | Illinois | 60612 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS | Chicago | Illinois | 60614 | United States |
| Tulane Univ. New Orleans NICHD CRS | New Orleans | Louisiana | 701122699 | United States |
| Univ. of Maryland Baltimore NICHD CRS | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Univ. Baltimore NICHD CRS | Baltimore | Maryland | 21287 | United States |
| Boston Medical Center Ped. HIV Program NICHD CRS | Boston | Massachusetts | 02118 | United States |
| WNE Maternal Pediatric Adolescent AIDS CRS | Worcester | Massachusetts | 016550001 | United States |
| Rutgers - New Jersey Medical School CRS | Newark | New Jersey | 07103 | United States |
| Nyu Ny Nichd Crs | New York | New York | 10016 | United States |
| Harlem Hosp. Ctr. NY NICHD CRS | New York | New York | 10037 | United States |
| SUNY Upstate Med. Univ., Dept. of Peds. | Syracuse | New York | 13210 | United States |
| Bronx-Lebanon Hospital Center NICHD CRS | The Bronx | New York | 10457 | United States |
| Jacobi Med. Ctr. Bronx NICHD CRS | The Bronx | New York | 10461 | United States |
| DUMC Ped. CRS | Durham | North Carolina | 277103499 | United States |
| Philadelphia IMPAACT Unit CRS | Philadelphia | Pennsylvania | 19104 | United States |
| St. Christopher's Hosp. for Children | Philadelphia | Pennsylvania | 191341095 | United States |
| St. Jude Children's Research Hospital CRS | Memphis | Tennessee | 38105 | United States |
| Children's Med. Ctr. Dallas | Dallas | Texas | 75235 | United States |
| Texas Children's Hospital CRS | Houston | Texas | 77030 | United States |
| Children's Hosp. of the King's Daughters, Infectious Disease | Norfolk | Virginia | 23507 | United States |
| Childrens Hosp. of the Kings Daughters | Norfolk | Virginia | 23507 | United States |
| Seattle Children's Research Institute CRS | Seattle | Washington | 98105 | United States |
| Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds. | Bayamón | 00956 | Puerto Rico |
| San Juan City Hosp. PR NICHD CRS | San Juan | 00936 | Puerto Rico |
| Soweto IMPAACT CRS | Johannesburg | Gauteng | 1864 | South Africa |
| Shandukani CRS | Johannesburg | Gauteng | 2001 | South Africa |
| Background |
| Kiser JJ, Rutstein RM, Samson P, Graham B, Aldrovandi G, Mofenson LM, Smith E, Schnittman S, Fenton T, Brundage RC, Fletcher CV. Atazanavir and atazanavir/ritonavir pharmacokinetics in HIV-infected infants, children, and adolescents. AIDS. 2011 Jul 31;25(12):1489-96. doi: 10.1097/QAD.0b013e328348fc41. |
| Background | Aldrovandi G, Samson P, Fenton T, Schnittman S, Rutstein R, Ortiz A and the Pediatric AIDS Clinical Trial 1020A Group. Resistance to Atazanavir (ATV), Lopinavir (LPV), Tenofovir (TFV) Among Heavily Experienced Pediatric Patients. 12th International Symposium on HIV and Emerging Infectious Diseases in Toulon, France, June 2002. |
| Background | Aldrovandi G, Samson P, Fenton T, Schnittman S, and Rutstein R for the P1020A Team. Genotypic and phenotypic resistance to BMS232632 (Atazanavir-ATV), among heavily experienced pediatric patients who were ATV-naïve. 9th Conference on Retroviruses and Opportunistic Infections, February 24 - 28, 2002, Seattle, WA. |
| Background | Kiser J, Rutstein R, Aldrovandi G, Samson P, Graham B, Schnittman S, Smith M, Mofenson L, Fletcher C, and the PACTG 1020A Study Team. Pharmacokinetics of atazanavir/ritonavir in HIV-infected infants, children, and adolescents: PACTG 1020A. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 2005. |
| Background | Kiser J, Rutstein R, Samson P, Graham B, Aldrovandi G, Mofenson L, Smith E, Zhang J, Biguenet S, Fletcher C, and the P1020A team. Atazanavir dosing conversion and pharmacokinetics in HIV-infected children switching from atazanavir powder to capsules. 12 th International Workshop on Clinical Pharmacology of HIV Therapy, Miami, Florida, April 2011. |
| Background | Meyers T, Rutstein R, Samson P, Violari A, Palmer M, Kiser J, Fletcher C, Fenton T, Mofenson L, Graham B, Schnittman S, Horga M, Aldrovandi G, for the PACTG 1020A Study. Treatment responses to atazanavir-containing HAART in a drug-naïve pediatric population in South Africa. 15th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 2008. |
| Background | Rutstein R, Samson P, Aldrovandi G, Graham B, Schnittman S, Fletcher C, Kiser J, Smith E, Mofenson L, Fenton T, and the PACTG 1020A Study Team. Effect of atazanavir on serum cholesterol and triglyceride levels in HIV-infected infants, children, and adolescents: PACTG 1020A. 12th Conference on Retroviruses and Opportunistic Infections, Boston, MA, February 2005. |
| Background | Rutstein R, Samson P, Fenton T, Kiser J, Fletcher C, Schnittman S, Mofenson L, Smith E, Graham B, Aldrovandi G, PACTG 1020A Study. The NIH PACTG Protocol 1020A: ATAZANAVIR (ATV), +/- RITONAVIR in HIV-Infected Infants, Children and Adolescents. Presented at the 14th Conference on Retrovirus and Opportunistic Infection (CROI), Los Angeles, CA, February, 2007. |
| Background | Samson P, Rutstein R, Schnittman S, Ortiz A, Graham B, Fenton T, Aldrovandi G and the Pediatric AIDS Clinical Trials Group P1020A Study Team. Effects of Antiretroviral (ARV) Exposure and Genotypic (Geno) Mutations in Predicting Phenotypic Resistance (PRS) to Atazanavir (ATV), Lopinavir (LPV), and Tenofovir (TDF) in Patients Naïve to these Drugs. 13th International Symposium on HIV and Emerging Infectious Diseases, Toulon, France, June 2004. |
| Background | Samson P, Rutstein R, Fenton T, Kiser J, Fletcher C, Schnittman S, Mofenson L, Smith E, Graham B, Aldrovandi G, and the PACTG 1020A Study Team. Changes in cholesterol and triglyceride levels among pediatric subjects treated with atazanavir, with or without ritonavir boosting: the 1020A NIH PACTG protocol. 13th Conference on Retroviruses and Opportunistic Infections, Denver, CO, February 2006. |
Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.
| FG002 | Group 2: ATV Powder (310mg/m^2) | Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs. |
| FG003 | Group 2: ATV Powder (620mg/m^2) | Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs. |
| FG004 | Group 3: ATV Capsule (310mg/m^2) | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They will received ATV (capsule) and two NRTIs. |
| FG005 | Group 3: ATV Capsule (415mg/m^2) | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. |
| FG006 | Group 3: ATV Capsule (520mg/m^2) | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. Note: This is the final recommended dose for this group. |
| FG007 | Group 4: ATV Capsule (310mg/m^2) | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. |
| FG008 | Group 4: ATV Capsule (520mg/m^2) | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. |
| FG009 | Group 4: ATV Capsule (620mg/m^2) | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. Note: This is the final recommended dose for this group. |
| FG010 | Group 5: ATV Powder (310mg/m^2) + RTV | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. Note: This is the final recommended dose for this group. |
| FG011 | Group 5a: ATV Powder (310mg/m^2) + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. Note: This is the final recommended dose for this group. |
| FG012 | Group 6: ATV Powder (310mg/m^2) + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. Note: This is the final recommended dose for this group. |
| FG013 | Group 7: ATV Capsule (310mg/m^2) + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. |
| FG014 | Group 7: ATV Capsule (205mg/m^2) + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. Note: This is the final recommended dose for this group. |
| FG015 | Group 8: ATV Capsule (310mg/m^2) + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. |
| FG016 | Group 8: ATV Capsule (205mg/m^2) + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. Note: This is the final recommended dose for this group. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Participants accrued and treated at the dose ultimately selected for their groups.
NOTE: (1) Final Dose not established for Grps 1, 2; (2) Grp 5a started with n=12, but (1) participant inadvertently enrolled,never received ATV, final n=11; (3) Grp 8 started with n=15, but (1) participant inadvertently enrolled, never received ATV, final n=14.
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| ID | Title | Description |
|---|---|---|
| BG000 | Step I: Group 3 (ATV Final Dose: 520mg/m^2 Capsule) | Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 520mg/m^2 |
| BG001 | Step I: Group 4 (ATV Final Dose: 620mg/m^2 Capsule) | Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 |
| BG002 | Step I: Group 5 (ATV Final Dose: 310mg/m^2 Powder + RTV) | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| BG003 | Step I: Group 5a (ATV Final Dose: 310mg/m^2 Powder + RTV) | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| BG004 | Step I: Group 6 (ATV Final Dose: 310mg/m^2 Powder + RTV) | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| BG005 | Step I: Group 7 (ATV Final Dose: 205mg/m^2 Capsule + RTV) | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| BG006 | Step I: Group 8 (ATV Final Dose: 205mg/m^2 Capsule + RTV) | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| CD4 Count | Median | Full Range | cells/mm^3 |
| |||||||||||||||
| CD4 Percent | Median | Full Range | percentage of total lymphocytes |
| |||||||||||||||
| HIV-RNA | Median | Full Range | log10 copies/ml |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced a Safety Endpoint of Interest Attributed to ATV | Total Bilirubin >= 5.1xULN, ECG Events and Other Grade 3+ toxicities attributed to study treatment. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) Toxicity Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study team. | Patients accrued at the final recommended dose for each group. | Posted | Number | participants | From study entry up to week 96 |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Died | Participants accrued at the final recommended dose for each group. | Posted | Number | participants | From study entry up to week 96 |
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV RNA <400 Copies/mL at Week 24 | Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa. | Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data). Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an 'intent-to-treat' (ITT) approach, in which children who discontinued study treatment for any reason were considered failures. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV RNA <400 Copies/mL at Week 48 | Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa. | Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data). Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an 'intent-to-treat' (ITT) approach, in which children who discontinued study treatment for any reason were considered failures. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 48 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HIV RNA <400 Copies/mL at Week 96 | Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer's instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa. | Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data). Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an 'intent-to-treat' (ITT) approach, in which children who discontinued study treatment for any reason were considered failures. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 96 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC24h) | Pharmacokinetics were determined by non-compartmental analysis and AUC0-24hr calculated by the linear trapezoidal method. | Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group. | Posted | Median | Inter-Quartile Range | ng*hr/mL | Week 1 (Day 7) Intensive PK-24hr (Pre-Dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Pharmacokinetic (PK) Parameter: Minimum Plasma Concentration (C24) | Pharmacokinetics were determined by non-compartmental analysis. C24 determined visually, except in the instance when the patient re-dosed the study medication prior to the 24 hour blood draw or the 24 hour level was not obtained, in which case the C24 was calculated from the elimination rate (ke) and the last measured concentration. | Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group. | Posted | Median | Inter-Quartile Range | ng/mL | Week 1 (Day 7) Intensive PK-24hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) | Pharmacokinetics were determined by non-compartmental analysis and Maximum concentration (Cmax) was determined visually. | Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group. | Posted | Median | Inter-Quartile Range | ng/mL | Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Pharmacokinetic (PK) Parameter: Clearance (CL/F) | Pharmacokinetics were determined by non-compartmental analysis and Apparent oral clearance (CL/F) was calculated as ATV dose divided by AUC0-24hr. | Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group. | Posted | Median | Inter-Quartile Range | L/hr/m^2 | Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4 Count (Cells/mm^3) From Baseline to Week 20 | Participants accrued at the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. | Posted | Median | Full Range | Cells/mm^3 | Baseline, Week 20 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4 Count (Cells/mm^3) From Baseline to Week 48 | Patients accrued to the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. | Posted | Median | Full Range | Cells/mm^3 | Baseline, Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4 Count (Cells/mm^3) From Baseline to Week 96 | Patients accrued to the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. | Posted | Median | Full Range | cells/mm^3 | Baseline, Week 96 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4 Percent From Baseline to Week 20 | Patients accrued to the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. | Posted | Median | Full Range | percentage of total lymphocytes | Baseline, Week 20 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4 Percent From Baseline to Week 48 | Patients accrued to the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. | Posted | Median | Full Range | percentage of total lymphocytes | Baseline, Week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4 Percent From Baseline to Week 96 | Patients accrued to the final recommended dose for each group (with evaluable CD4 data). CD4 changes from baseline were calculated in an 'as-treated' analysis' such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis. | Posted | Median | Full Range | percentage of total lymphocytes | Baseline, Week 96 |
|
From first study enrollment (16 November 2000) up to the last off-study visit (15 September 2014)
P1020A followed intensive reporting requirements defined in DAIDS Serious Adverse Experience Reporting Manual. AEs graded according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-Threatening, Gr 5=Death.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 3: ATV 520mg/m^2 Capsule | 2 years and 1 day (731 days or more) to 13 years of age. ATV capsule + 2 NRTIs Note: This is the final recommended dose for this group. | 10 | 21 | 21 | 21 | ||
| EG001 | Group 4: ATV 620mg/m^2 Capsule | 13 years and 1 day to 21 (not including the 22nd birthday) years of age. ATV capsule + 2 NRTIs Note: This is the final recommended dose for this group. | 15 | 25 | 25 | 25 | ||
| EG002 | Group 5: ATV 310mg/m^2 Powder + RTV | 91 days to 2 years of age (less than or exactly 730 days. ATV powder + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. | 12 | 21 | 21 | 21 | ||
| EG003 | Group 6: ATV 310mg/m^2 Powder + RTV | 2 years and 1 day (731 days or more) to 13 years of age. ATV powder + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. | 14 | 26 | 26 | 26 | ||
| EG004 | Group 7: ATV 205mg/m^2 Capsule + RTV | 2 years and 1 day (731 days or more) to 13 years of age. ATV capsule + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. | 15 | 24 | 24 | 24 | ||
| EG005 | Group 8: ATV 205mg/m^2 Capsule + RTV | 13 years and 1 day to 21 (not including the 22nd birthday) years of age. ATV capsule + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. | 8 | 14 | 14 | 14 | ||
| EG006 | Group 5A: ATV 310mg/m^2 Powder + RTV | 91 to 180 days of age. ATV powder + ritonavir + 2 NRTIs Note: This is the final recommended dose for this group. | 5 | 11 | 11 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block second degree | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Facial wasting | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lipoatrophy | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Middle ear effusion | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gingival ulceration | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lip ulceration | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rectal fissure | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rectal lesion | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Secretion discharge | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Immune reconstitution inflammatory syndrome | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Helminthic infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Immune reconstitution inflammatory syndrome associated tuberculosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Meningitis haemophilus | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Staphylococcal impetigo | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Streptococcal impetigo | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tinea capitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tinea faciei | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood bilirubin | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood bilirubin unconjugated | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood calcium abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood calcium decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood cholesterol abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood potassium abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood sodium abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood sodium increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood urea abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Breath sounds abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| High density lipoprotein abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Low density lipoprotein abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatic enzymes abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Clubbing | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lower extremity mass | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Agoraphobia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anger | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Enuresis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fibrocystic breast disease | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Genital rash | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Perineal rash | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulval disorder | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vulvovaginal rash | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eosinophilic pustular folliculitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Facial wasting | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lipoatrophy | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lipodystrophy acquired | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Papule | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pityriasis alba | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin plaque | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Umbilical haematoma | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urticaria chronic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Allen, Director, IMPAACT Operations Center | Family Health International (FHI 360) | (919) 405-1429 | mallen@fhi360.org |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Black Non-Hispanic |
|
| Hisp-Regardless of Race |
|
| More than one race |
|
| Unavailable |
|
| Increase in PR Interval-Grade 1 |
|
| Increase in PR Interval-Grade 2 |
|
| Heart Rate-Grade 2 |
|
| Heart Rate-Grade 3 |
|
| Increase in QTc Interval-Grade 3 |
|
| Other Grade 3+ Toxicities |
|
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
|
|
Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 |
| OG002 | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6 : ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
|
|
Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 |
| OG002 | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
|
|
Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. ATV Final Recommended Dose: 620mg/m^2 |
| OG002 | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
|
|
| OG002 |
| Step I: Group 5: ATV 310mg/m^2 Powder + RTV |
Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
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| OG002 | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
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| OG002 | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
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| OG002 | Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV | Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
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Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
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Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
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Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
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Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
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Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
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Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG003 | Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV | Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG004 | Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV | Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 310mg/m^2 |
| OG005 | Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV | Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
| OG006 | Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV | Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs. ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in. Ritonavir: Administered as 100 mg capsules or oral solution. ATV Final Recommended Dose: 205mg/m^2 |
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