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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI068632 | U.S. NIH Grant/Contract | View source | |
| 10167 |
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The study was prematurely discontinued due to administrative reasons.
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Treatment of HIV with combination antiretroviral regimens frequently results in the suppression of HIV viral load, significant immune recovery, and delayed disease progression. However, treatment with these regimens, particularly protease inhibitors (PIs), has been associated with significant increases in cholesterol and triglycerides in HIV-infected adults and children. The purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, a FDA-approved drug which lowers cholesterol and triglyceride levels, in HIV-infected children receiving stable antiretroviral regimens.
Antiretroviral regimens, particularly those containing PIs, often cause hyperlipidemia, which is an increase in the amount of fat (such as cholesterol and triglycerides) in the blood. These increases can lead to heart disease and pancreatitis. Although the mechanism by which PIs cause hyperlipidemia is not clearly understood, there are medications to combat this side effect. The primary purpose of this study was to evaluate the safety and effectiveness of escalating doses of atorvastatin, based on low-density lipoprotein cholesterol (LDL-C) levels, in HIV-infected children receiving stable antiretroviral therapy.
Participants were assigned to one of two groups based on age (10 to 14 years or 15 to 23 years) and were treated for a maximum of 48 weeks. The first six participants enrolled in the study were in the 15 to 23 year old age group. Once safety data through week 8 on these 6 participants was analyzed, the remaining participants were enrolled. All participants received atorvastatin in combination with a stable antiretroviral regimen. Each participant was followed independently according to a dose escalation algorithm for atorvastatin. Participants began dosing at 10 mg daily. If efficacy criteria were not met, dosing increased to 20 mg daily at week 8. Since dose escalations were done within subject, safety and efficacy rates were presented for the dose-escalation strategy overall and not for individual doses. Atorvastatin was provided by the study, but antiretrovirals were not.
Study visits occurred at study entry and weeks 4, 8, 12, 24, 36, and 48. Safety labs were collected at all study visits. Blood collection for lipid measurements occurred at weeks 4, 12, 24 and 48.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age 10 to 14 | Experimental | Participants ages 10 to 14 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen |
|
| Age 15 to 23 | Experimental | Participants ages 15 to 23 years receiving oral atorvastatin for 48 weeks while on a stable antiretroviral regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading 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 core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. | Study entry to weeks 12, 24, and 48 |
| Percentage of Participants Experiencing at Least One Adverse Event (AE) | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading 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. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. | Study entry to weeks 12, 24, and 48 |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat) | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. | Study entry and weeks 4, 12, 24, and 48 |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available) | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. | Study entry and weeks 4, 12, 24, and 48 |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol) | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Fasting Total Cholesterol (TC) From Study Entry | Study entry and weeks 4, 12, 24, and 48 | |
| Percent Change in Triglycerides (TG) From Study Entry | Study entry and weeks 4, 12, 24, and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Melvin, MD | Seattle Children's Hospital | Study Chair |
| Marilyn Crain, MD, MPH | University of Alabama at Birmingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ. of Colorado Denver NICHD CRS (5052) | Aurora | Colorado | 80045 | United States | ||
| Univ. of Miami Ped. Perinatal HIV/AIDS CRS (4201) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15030304 | Background | Kamin D, Hadigan C. Hyperlipidemia in children with HIV infection: an emerging problem. Expert Rev Cardiovasc Ther. 2003 May;1(1):143-50. doi: 10.1586/14779072.1.1.143. | |
| 14727985 | Background | Penzak SR, Chuck SK. Management of protease inhibitor-associated hyperlipidemia. Am J Cardiovasc Drugs. 2002;2(2):91-106. doi: 10.2165/00129784-200202020-00003. |
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Recruitment occurred between August 31, 2009 (date first participant enrolled) and December 16, 2013 (date last participant enrolled).
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin | 10 mg to 20 mg atorvastatin taken orally once daily. Dosage starts at 10 mg and is increased to 20 mg at week 8 if efficacy criteria is not met at week 4. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| Study entry and weeks 4, 12, 24, and 48 |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. | Study entry and weeks 4, 12, 24, and 48 |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. | Study entry and weeks 4, 12, 24, and 48 |
| Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. | Study entry and weeks 4, 12, 24, and 48 |
| Percent Change in LDL Cholesterol (LDL-C) From Study Entry | Study entry and weeks 4, 12, 24, and 48 |
| Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading 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 core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. | Study entry to weeks 12, 24, and 48 |
| Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading 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. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. | Study entry to weeks 12, 24, and 48 |
| Percent Change in HDL-cholesterol (HDL-C) From Study Entry | Study entry and weeks 4, 12, 24, and 48 |
| Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry | Study entry and weeks 12, 24, and 48 |
| Percent Change in Apolipoprotein B (Apo B) From Study Entry | Study entry and weeks 12, 24, and 48 |
| Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry | Study entry and weeks 12, 24, and 48 |
| Percent Change in Interleukin 6 (IL-6) From Study Entry | Study entry and weeks 12, 24, and 48 |
| Percentage of Participants With Undetectable Plasma HIV-1 RNA | Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used. | Study entry and weeks 12, 24, and 48 |
| Miami |
| Florida |
| 33136 |
| United States |
| University of South Florida Tampa (5018) | Tampa | Florida | 33620 | United States |
| Chicago Children's CRS (4001) | Chicago | Illinois | 60614 | United States |
| Tulane University (5095) | New Orleans | Louisiana | 70112 | United States |
| Boston Medical Center Ped. HIV Program NICHD CRS (5011) | Boston | Massachusetts | 02118 | United States |
| New York University NY (5012) | New York | New York | 10016 | United States |
| Metropolitan Hospital (5003) | New York | New York | 10029 | United States |
| Bronx-Lebanon Hospital IMPAACT CRS (6901) | The Bronx | New York | 10457 | United States |
| St. Jude/UTHSC CRS (6501) | Memphis | Tennessee | 38105 | United States |
| Texas Children's Hosp. CRS (3801) | Houston | Texas | 77030 | United States |
| 16314198 | Background | Solorzano Santos F, Gochicoa Rangel LG, Palacios Saucedo G, Vazquez Rosales G, Miranda Novales MG. Hypertriglyceridemia and hypercholesterolemia in human immunodeficiency virus-1-infected children treated with protease inhibitors. Arch Med Res. 2006 Jan;37(1):129-32. doi: 10.1016/j.arcmed.2005.05.013. |
| Background | The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, August 2009) |
| Dose Increased to 20 mg at Week 8 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who initiated Atorvastatin were included in the baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin | 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| CD4 Percent at screening, Categorical | Number | participants |
| |||||||||||||||||||||||
| HIV-1 RNA, Categorical | Number | participants |
| |||||||||||||||||||||||
| Antiretroviral (ARV) Regimen at entry, Categorical | ARV regimens are categorized based on whether or not they contain Protease Inhibitors (PIs) and/or Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs). | Number | participants |
|
| 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 | Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading 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 core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. | All participants who initiated Atorvastatin. | Posted | Number | 90% Confidence Interval | percentage of participants | Study entry to weeks 12, 24, and 48 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing at Least One Adverse Event (AE) | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading 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. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. | All participants who initiated Atorvastatin. | Posted | Number | 90% Confidence Interval | percentage of participants | Study entry to weeks 12, 24, and 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Intention to Treat) | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. | All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week. | Posted | Number | 90% Confidence Interval | percentage of participants | Study entry and weeks 4, 12, 24, and 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Data Available) | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. | All participants who initiated study treatment and have LDL-C data available at study entry and the specified week. | Posted | Number | 90% Confidence Interval | percentage of participants | Study entry and weeks 4, 12, 24, and 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria (Per Protocol) | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. | All participants who completed the study per protocol (initiated study drug, had LDL-C data available at all required study visits, attended study visits within the protocol-specified window, were dose-escalated according to protocol, and reported adherence to study drug at all study visits). | Posted | Number | 90% Confidence Interval | percentage of participants | Study entry and weeks 4, 12, 24, and 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria and Did Not Experience a Primary Safety Endpoint Attributable to Study Drug | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. | All participants who initiated Atorvastatin and did not experience a primary safety event attributable to Atorvastatin. | Posted | Number | 90% Confidence Interval | percentage of participants | Study entry and weeks 4, 12, 24, and 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by Age Group | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. | All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week. | Posted | Number | 90% Confidence Interval | percentage of participants | Study entry and weeks 4, 12, 24, and 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Met the LDL Cholesterol (LDL-C) Efficacy Criteria by NNRTI Treatment | Efficacy was defined as having LDL-C of 110 mg/dL or less or at least 30% decline in LDL-C from baseline to the specified week. | All participants who initiated Atorvastatin. If a participant was missing data at a given week, treatment was assumed to be non-efficacious at that week. | Posted | Number | 90% Confidence Interval | percentage of participants | Study entry and weeks 4, 12, 24, and 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percent Change in LDL Cholesterol (LDL-C) From Study Entry | All participants who initiated Atorvastatin and had LDL-C data available at study entry and the specified week. | Posted | Mean | 90% Confidence Interval | percentage of LDL-C at study entry | Study entry and weeks 4, 12, 24, and 48 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Fasting Total Cholesterol (TC) From Study Entry | All participants who initiated Atorvastatin and had total cholesterol data available at study entry and the specified week. | Posted | Mean | 90% Confidence Interval | percentage of TC at study entry | Study entry and weeks 4, 12, 24, and 48 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Triglycerides (TG) From Study Entry | All participants who initiated Atorvastatin and had triglycerides data available at study entry and the specified week. | Posted | Mean | 90% Confidence Interval | percentage of TG at study entry | Study entry and weeks 4, 12, 24, and 48 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in HDL-cholesterol (HDL-C) From Study Entry | All participants who initiated Atorvastatin and had HDL-C data available at study entry and the specified week. | Posted | Mean | 90% Confidence Interval | percentage of HDL-C at study entry | Study entry and weeks 4, 12, 24, and 48 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Apolipoprotein A1 (Apo A-1) From Study Entry | All participants who initiated Atorvastatin and had Apo A-1 data available at study entry and the specified week. | Posted | Mean | 90% Confidence Interval | percentage of Apo A-1 at study entry | Study entry and weeks 12, 24, and 48 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Apolipoprotein B (Apo B) From Study Entry | All participants who initiated Atorvastatin and had Apo B data available at study entry and the specified week. | Posted | Mean | 90% Confidence Interval | percentage of Apo B at study entry | Study entry and weeks 12, 24, and 48 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in High-sensitivity CRP (Hs-CRP) From Study Entry | All participants who initiated Atorvastatin and had hs-CRP data available at study entry and the specified week. | Posted | Median | 90% Confidence Interval | percentage of hs-CRP at study entry | Study entry and weeks 12, 24, and 48 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Interleukin 6 (IL-6) From Study Entry | All participants who initiated Atorvastatin and had IL-6 data available at study entry and the specified week. | Posted | Median | 90% Confidence Interval | percentage of IL-6 at study entry | Study entry and weeks 12, 24, and 48 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Undetectable Plasma HIV-1 RNA | Undetectable is defined as plasma HIV-1 RNA below the lower limit of quantification of the assay used. | All study participants who initiated Atorvastatin and had HIV-1 RNA data available at the specified week. | Posted | Number | 90% Confidence Interval | percentage of participants | Study entry and weeks 12, 24, and 48 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing at Least One Treatment-related Adverse Event (AE) by Age Group | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading 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 core study team. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. | All participants who initiated Atorvastatin. | Posted | Number | 90% Confidence Interval | percentage of participants | Study entry to weeks 12, 24, and 48 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing at Least One Adverse Event (AE) by Age Group | AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading 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. The primary outcome measure includes any AE of grade 3 or higher and liver function tests (LFTs) of grade 2 or higher. | All participants who initiated Atorvastatin. | Posted | Number | 90% Confidence Interval | percentage of participants | Study entry to weeks 12, 24, and 48 |
|
|
From date of Atorvastatin initiation until Week 48.
The DAIDS Adverse Event (AE) Grading Table (Version 1.0) was used for grading of AEs. Expedited adverse event reporting followed Version 2.0 of the DAIDS Expedited Adverse Event Manual.
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 | Atorvastatin | 10 mg to 20 mg atorvastatin taken orally once daily. Dosage is dependent on efficacy criteria. | 3 | 28 | 27 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood glucose decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
Target enrollment was 40 participants (20 in each age cohort). However, the study was prematurely discontinued due to administrative reasons, having enrolled only 28 participants (21 participants aged 10 to 14 and 7 participants aged 15 to 23).
In accordance with the Clinical Trial 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 |
| D006949 | Hyperlipidemias |
| 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 |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| 19 - <24 years old |
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| Hispanic (Regardless of Race) |
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| Asian, Pacific Islander |
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| At least one NNRTI and no PI |
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| Other ARV regimen |
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| Title | Measurements |
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| Title | Denominators | Categories |
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| Percent change in LDL-C at Week 4 (N=27) |
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| Percent change in LDL-C at Week 12 (N=27) |
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| Percent change in LDL-C at Week 24 (N=26) |
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| Percent change in LDL-C at Week 48 (N=26) |
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| Title | Denominators | Categories |
|---|
| Percent change in TC at Week 4 (N=27) |
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| Percent change in TC at Week 12 (N=27) |
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| Percent change in TC at Week 24 (N=26) |
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| Percent change in TC at Week 48 (N=26) |
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| Title | Denominators | Categories |
|---|
| Percent change in TG at Week 4 (N=27) |
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| Percent change in TG at Week 12 (N=27) |
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| Percent change in TG at Week 24 (N=26) |
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| Percent change in TG at Week 48 (N=26) |
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| Title | Denominators | Categories |
|---|
| Percent change in HDL-C at Week 4 (N=27) |
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| Percent change in HDL-C at Week 12 (N=27) |
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| Percent change in HDL-C at Week 24 (N=26) |
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| Percent change in HDL-C at Week 48 (N=26) |
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| Title | Denominators | Categories |
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| Percent change in Apo A-1 at Week 12 (N=24) |
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| Percent change in Apo A-1 at Week 24 (N=23) |
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| Percent change in Apo A-1 at Week 48 (N=24) |
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| Title | Denominators | Categories |
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| Percent change in Apo B at Week 12 (N=24) |
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| Percent change in Apo B at Week 24 (N=23) |
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| Percent change in Apo B at Week 48 (N=24) |
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| Title | Denominators | Categories |
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| Percent change in hs-CRP at Week 12 (N=25) |
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| Percent change in hs-CRP at Week 24 (N=23) |
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| Percent change in hs-CRP at Week 48 (N=24) |
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| Title | Denominators | Categories |
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| Percent change in IL-6 at Week 12 (N=24) |
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| Percent change in IL-6 at Week 24 (N=23) |
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| Percent change in IL-6 at Week 48 (N=24) |
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| Units |
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| Counts |
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| Participants |
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| Participants |
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