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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI068636 | U.S. NIH Grant/Contract | View source | |
| ACTG 5224s | Other Identifier | Substudy |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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Currently, the preferred anti-HIV regimens used in the United States consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV). However, with new anti-HIV drugs being approved, alternative regimens need to be tested to determine if new drug combinations have increased effectiveness in treating HIV. The purpose of this study is to test the safety, tolerability, and effectiveness of four different regimens in HIV-infected adults who have never taken anti-HIV drugs.
Antiretroviral (ARV) treatment regimens consisting of EFV and two NRTIs are the most commonly prescribed regimens for the initial therapy of HIV-infected people in the United States. Such regimens are popular because the drugs are easy to administer, have overall excellent efficacy, and are well tolerated. However, because of concerns about long-term drug toxicity, the development of drug resistance, and potential complications in pregnant women, it is imperative that other drug combinations be investigated as possible alternative initial regimens. Drugs recently approved by the Food and Drug Administration (FDA) for HIV treatment include the protease inhibitor (PI) atazanavir (ATV) and the two NRTI coformulations emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) and abacavir/lamivudine (ABC/3TC). Data are limited on the efficacy of these new drugs when part of anti-HIV drug regimens. This study will evaluate and compare the safety, tolerability, and efficacy of four different treatment regimens in HIV-infected treatment-naive adults.
The treatment portion of this study will last 96 weeks after the last participant is enrolled. Participants will be randomly assigned to one of four arms:
NOTE: Lopinavir/ritonavir may be used in substitution of other drugs for certain participants.
Study visits will occur at study entry; Weeks 1, 2, 4, 8, 16, and 24; and every 12 weeks thereafter. A physical exam, blood collection, and urine collection will occur at most visits. Two pharmacokinetic blood samples will be collected from participants between Weeks 4 and 24. Participants will undergo adherence training at study entry and will be asked to complete adherence questionnaires at selected study visits. Some participants will be asked to participate in ACTG A5224s, a metabolic substudy of ACTG A5202.
The Data Safety Monitoring Board (DSMB) for A5202 met in January 2008 to review the study. After reviewing the study information, the DSMB noted that certain study regimens were significantly less effective than others. Specifically, ABC/3TC-containing regimens were not as effective in controlling the virus as TDF/FTC-containing regimens for participants entering the study with high viral loads. The DSMB also commented that participants assigned to ABC/3TC had a shorter time until they experienced side effects than participants assigned to TDF/FTC. The DSMB had no safety concerns for the other drug comparisons.
Based on DSMB review, in Feb 2008 participants who started the study with high viral loads were told whether they were taking ABC/3TC or TDF/FTC and offered the option to continue or change their NRTI study drug component, after discussion with their doctor. For participants who started the study with lower screening viral loads, study treatment continued without change.
For 74 participant the reason for first treatment modification was "unblinded and switched" as a consequence of the DSMB results (33 on EFV, ABC/3TC, and placebo FTC/TDF arm; 1 on RTV-boosted ATV, FTC/TDF, and placebo ABC/3TC arm; and 40 on RTV-boosted ATV, ABC/3TC, and placebo FTC/TDF arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EFV, FTC/TDF, and placebo ABC/3TC | Experimental | Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks |
|
| EFV, ABC/3TC and placebo FTC/TDF | Experimental | Participants will receive EFV, ABC/3TC, and placebo for FTC/TDF for at least 96 weeks |
|
| RTV-boosted ATV, FTC/TDF, and placebo ABC/3TC | Experimental | Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks |
|
| RTV-boosted ATV, ABC/3TC, and placebo FTC/TDF | Experimental | Participants will receive RTV-boosted ATV, ABC/3TC, and placebo for FTC/TDF for at least 96 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abacavir/Lamivudine | Drug | 600 mg abacavir/300 mg lamivudine tablet taken orally daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From Randomization to Virologic Failure | Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure. | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| Time From Treatment Dispensation to a Grade 3/4 Safety Event | Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. | All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks. |
| Time From Treatment Dispensation to Treatment Modification | Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification) | Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Study Follow-up | Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact. | Follow-up time was variable, median follow-up was 138 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Daar, MD | Harbor-UCLA Medical Center, Los Angeles Biomedical Research Institute | Study Chair |
| Paul Sax, MD | Division of Infectious Diseases, Brigham and Women's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Usc Crs (1201) | Los Angeles | California | 90033 | United States | ||
| UCLA CARE Center CRS (601) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15479772 | Background | Anderson PL. Pharmacologic perspectives for once-daily antiretroviral therapy. Ann Pharmacother. 2004 Nov;38(11):1924-34. doi: 10.1345/aph.1E036. Epub 2004 Oct 12. | |
| 15503932 | Background | Kress KD. HIV update: emerging clinical evidence and a review of recommendations for the use of highly active antiretroviral therapy. Am J Health Syst Pharm. 2004 Oct 1;61 Suppl 3:S3-14; quiz S15-6. doi: 10.1093/ajhp/61.suppl_3.S3. |
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1864 were randomized. Results reported for 1857 eligible participants; 7 were subsequently found ineligible and excluded from all analyses.
Recruited at AIDS Clinical Trials Units in the United States and Puerto Rico. Recruitment occurred between September 21, 2005 (date first subject was randomized) and November 20, 2007 (date last subject was randomized).
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| ID | Title | Description |
|---|---|---|
| FG000 | EFV, FTC/TDF, and Placebo ABC/3TC | Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks |
| FG001 | EFV, Placebo FTC/TDF, and ABC/3TC | Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Atazanavir | Drug | 300 mg tablet taken orally daily |
|
|
| Efavirenz | Drug | 600 mg tablet taken orally daily |
|
|
| Emtricitabine/Tenofovir disoproxil fumarate | Drug | 200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily |
|
|
| Ritonavir | Drug | 100 mg tablet taken orally daily |
|
|
| Abacavir/Lamivudine placebo | Drug | Placebo tablet taken orally daily |
|
|
| Emtricitabine/Tenofovir disoproxil fumarate placebo | Drug | Placebo tablet taken orally daily |
|
|
| Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL | At Weeks 48 and 96 |
| Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL | At Weeks 48 and 96 |
| Change in CD4 Count (Cells/mm3) From Baseline | Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values). | At Weeks 48 and 96 |
| Number of Participants With Virologic Failure and Emergence of Major Resistance | Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease. | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events. | AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details. | Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| Change in Fasting Total Cholesterol Level From Baseline | Only fasting results are included. The protocol did not require that samples be collected fasting. | At Weeks 48 and 96 |
| Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline | Only fasting results are included. The protocol did not require that samples be collected fasting. | At Weeks 48 and 96 |
| Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline | Only fasting results are included. The protocol did not require that samples be collected fasting. | At Weeks 48 and 96 |
| Change in Fasting Triglyceride Level From Baseline | Only fasting results are included. The protocol did not require that samples be collected fasting. | At Weeks 48 and 96 |
| Number of Participants With Virologic Failure | Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. | Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| Cumulative Probability of Not Experiencing Virologic Failure | Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. | At week 48 and 96 |
| Number of Participants With a Grade 3/4 Safety Event | Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. | Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks |
| Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event | Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. | At week 48 and 96 |
| Number of Participants With Treatment Modification | Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. | Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| Cumulative Probability of Not Experiencing Treatment Modification | Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. | At week 48 and 96 |
| Number of Participants With Regimen Failure | Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. | Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| Cumulative Probability of Not Experiencing Regimen Failure | Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. | At week 48 and 96 |
| Los Angeles |
| California |
| 90035 |
| United States |
| Stanford CRS (501) | Palo Alto | California | 94304 | United States |
| Ucsd, Avrc Crs (701) | San Diego | California | 92103 | United States |
| Ucsf Aids Crs (801) | San Francisco | California | 94110 | United States |
| San Mateo County AIDS Program (505) | Stanford | California | 94305-5107 | United States |
| Willow Clinic (507) | Stanford | California | 94305-5107 | United States |
| Harbor-UCLA Med. Ctr. CRS (603) | Torrance | California | 90502 | United States |
| University of Colorado Hospital CRS (6101) | Aurora | Colorado | 80045 | United States |
| Georgetown University CRS (GU CRS) (1008) | Washington D.C. | District of Columbia | 20007 | United States |
| University of Miami AIDS CRS (901) | Miami | Florida | 33139 | United States |
| Emory University | Atlanta | Georgia | 30308 | United States |
| The Ponce de Leon Center CRS (5802) | Atlanta | Georgia | 30308 | United States |
| Northwestern University CRS (2701) | Chicago | Illinois | 60611 | United States |
| Cook County Hospital Core Center (2705) | Chicago | Illinois | 60612 | United States |
| Rush Univ. Med. Ctr. ACTG CRS (2702) | Chicago | Illinois | 60612 | United States |
| Indiana University Hospital (2601) | Indianapolis | Indiana | 46202-5250 | United States |
| Wishard Hospital (2603) | Indianapolis | Indiana | 46202 | United States |
| Univ of Iowa Hosp and Clinic (1504) | Iowa City | Iowa | 52242 | United States |
| IHV Baltimore Treatment CRS (4651) | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Adult AIDS CRS (201) | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital ACTG CRS (101) | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hosp. ACTG CRS (107) | Boston | Massachusetts | 02115 | United States |
| Bmc Actg Crs (104) | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deaconess Med. Ctr., ACTG CRS (103) | Boston | Massachusetts | 02215 | United States |
| Washington U CRS (2101) | St Louis | Missouri | 63110 | United States |
| SUNY - Buffalo (Rochester) (1102) | Buffalo | New York | 14215 | United States |
| Cornell CRS (7804) | New York | New York | 10011 | United States |
| Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea (7803) | New York | New York | 10011 | United States |
| NY Univ. HIV/AIDS CRS (401) | New York | New York | 10016 | United States |
| HIV Prevention & Treatment CRS (30329) | New York | New York | 10032 | United States |
| Harlem ACTG CRS (31483) | New York | New York | 10037 | United States |
| AIDS Community Health Ctr. ACTG CRS (1108) | Rochester | New York | 14604 | United States |
| University of Rochester ACTG CRS (1101) | Rochester | New York | 14642 | United States |
| Unc Aids Crs (3201) | Chapel Hill | North Carolina | 27514 | United States |
| Wake County Department of Health (30076) | Chapel Hill | North Carolina | 27514 | United States |
| Duke University Medical Center Adult CRS (1601) | Durham | North Carolina | 27710 | United States |
| Moses H. Cone Memorial Hospital CRS (3203) | Greensboro | North Carolina | 27401 | United States |
| University of Cincinnati CRS (2401) | Cincinnati | Ohio | 45267 | United States |
| Case CRS (2501) | Cleveland | Ohio | 44106 | United States |
| Metro Health CRS (2503) | Cleveland | Ohio | 44109 | United States |
| The Ohio State Univ. AIDS CRS (2301) | Columbus | Ohio | 43210 | United States |
| Presbyterian Medical Center - Univ. of PA (6206) | Norristown | Pennsylvania | 19401 | United States |
| Hosp. of the Univ. of Pennsylvania CRS (6201) | Philadelphia | Pennsylvania | 19104 | United States |
| Pitt CRS (1001) | Pittsburgh | Pennsylvania | 15213 | United States |
| The Miriam Hosp. ACTG CRS (2951) | Providence | Rhode Island | 02906 | United States |
| Vanderbilt Therapeutics CRS (3652) | Nashville | Tennessee | 37232 | United States |
| Peabody Health Center CRS (31443) | Dallas | Texas | 75215 | United States |
| University of Texas, Galveston (6301) | Galveston | Texas | 77555-0435 | United States |
| University of Washington AIDS CRS (1401) | Seattle | Washington | 98104 | United States |
| University of Washington General Clinical Research (1403) | Seattle | Washington | 98104 | United States |
| Puerto Rico-AIDS CRS (5401) | San Juan | 00935 | Puerto Rico |
| 14668455 | Background | Robbins GK, De Gruttola V, Shafer RW, Smeaton LM, Snyder SW, Pettinelli C, Dube MP, Fischl MA, Pollard RB, Delapenha R, Gedeon L, van der Horst C, Murphy RL, Becker MI, D'Aquila RT, Vella S, Merigan TC, Hirsch MS; AIDS Clinical Trials Group 384 Team. Comparison of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med. 2003 Dec 11;349(24):2293-303. doi: 10.1056/NEJMoa030264. |
| 14668456 | Background | Shafer RW, Smeaton LM, Robbins GK, De Gruttola V, Snyder SW, D'Aquila RT, Johnson VA, Morse GD, Nokta MA, Martinez AI, Gripshover BM, Kaul P, Haubrich R, Swingle M, McCarty SD, Vella S, Hirsch MS, Merigan TC; AIDS Clinical Trials Group 384 Team. Comparison of four-drug regimens and pairs of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med. 2003 Dec 11;349(24):2304-15. doi: 10.1056/NEJMoa030265. |
| 38160309 | Derived | Cardone KM, Dudek S, Keat K, Bradford Y, Cindi Z, Daar ES, Gulick R, Riddler SA, Lennox JL, Sinxadi P, Haas DW, Ritchie MD. Lymphocyte Count Derived Polygenic Score and Interindividual Variability in CD4 T-cell Recovery in Response to Antiretroviral Therapy. Pac Symp Biocomput. 2024;29:594-610. |
| 33901188 | Derived | Li B, Veturi Y, Verma A, Bradford Y, Daar ES, Gulick RM, Riddler SA, Robbins GK, Lennox JL, Haas DW, Ritchie MD. Tissue specificity-aware TWAS (TSA-TWAS) framework identifies novel associations with metabolic, immunologic, and virologic traits in HIV-positive adults. PLoS Genet. 2021 Apr 26;17(4):e1009464. doi: 10.1371/journal.pgen.1009464. eCollection 2021 Apr. |
| 32829410 | Derived | Leonard MA, Cindi Z, Bradford Y, Bourgi K, Koethe J, Turner M, Norwood J, Woodward B, Erdem H, Basham R, Baker P, Rebeiro PF, Sterling TR, Hulgan T, Daar ES, Gulick R, Riddler SA, Sinxadi P, Ritchie MD, Haas DW. Efavirenz Pharmacogenetics and Weight Gain Following Switch to Integrase Inhibitor-Containing Regimens. Clin Infect Dis. 2021 Oct 5;73(7):e2153-e2163. doi: 10.1093/cid/ciaa1219. |
| 30642925 | Derived | Bednasz CJ, Venuto CS, Ma Q, Daar ES, Sax PE, Fischl MA, Collier AC, Smith KY, Tierney C, Acosta EP, Mager DE, Morse GD; AIDS Clinical Trials Group Study A5202 Team. Race/Ethnicity and Protease Inhibitor Use Influence Plasma Tenofovir Exposure in Adults Living with HIV-1 in AIDS Clinical Trials Group Study A5202. Antimicrob Agents Chemother. 2019 Mar 27;63(4):e01638-18. doi: 10.1128/AAC.01638-18. Print 2019 Apr. |
| 26009829 | Derived | Longenecker CT, Kitch D, Sax PE, Daar ES, Tierney C, Gupta SK, McComsey GA; AIDS Clinical Trials Group Study A5224s Team. Reductions in Plasma Cystatin C After Initiation of Antiretroviral Therapy Are Associated With Reductions in Inflammation: ACTG A5224s. J Acquir Immune Defic Syndr. 2015 Jun 1;69(2):168-77. doi: 10.1097/QAI.0000000000000557. |
| 24979445 | Derived | Mollan KR, Smurzynski M, Eron JJ, Daar ES, Campbell TB, Sax PE, Gulick RM, Na L, O'Keefe L, Robertson KR, Tierney C. Association between efavirenz as initial therapy for HIV-1 infection and increased risk for suicidal ideation or attempted or completed suicide: an analysis of trial data. Ann Intern Med. 2014 Jul 1;161(1):1-10. doi: 10.7326/M14-0293. |
| 24872136 | Derived | Sax PE, Zolopa A, Brar I, Elion R, Ortiz R, Post F, Wang H, Callebaut C, Martin H, Fordyce MW, McCallister S. Tenofovir alafenamide vs. tenofovir disoproxil fumarate in single tablet regimens for initial HIV-1 therapy: a randomized phase 2 study. J Acquir Immune Defic Syndr. 2014 Sep 1;67(1):52-8. doi: 10.1097/QAI.0000000000000225. |
| 24637543 | Derived | Erlandson KM, Kitch D, Tierney C, Sax PE, Daar ES, Melbourne KM, Ha B, McComsey GA. Impact of randomized antiretroviral therapy initiation on glucose metabolism. AIDS. 2014 Jun 19;28(10):1451-61. doi: 10.1097/QAD.0000000000000266. |
| 24384588 | Derived | Erlandson KM, Kitch D, Tierney C, Sax PE, Daar ES, Tebas P, Melbourne K, Ha B, Jahed NC, McComsey GA. Weight and lean body mass change with antiretroviral initiation and impact on bone mineral density. AIDS. 2013 Aug 24;27(13):2069-79. doi: 10.1097/QAD.0b013e328361d25d. |
| 24253247 | Derived | Smith KY, Tierney C, Mollan K, Venuto CS, Budhathoki C, Ma Q, Morse GD, Sax P, Katzenstein D, Godfrey C, Fischl M, Daar ES, Collier AC; AIDS Clinical Trials Group 5202 Study Team. Outcomes by sex following treatment initiation with atazanavir plus ritonavir or efavirenz with abacavir/lamivudine or tenofovir/emtricitabine. Clin Infect Dis. 2014 Feb;58(4):555-63. doi: 10.1093/cid/cit747. Epub 2013 Nov 18. |
| 23204164 | Derived | McComsey GA, Daar ES, O'Riordan M, Collier AC, Kosmiski L, Santana JL, Fichtenbaum CJ, Fink H, Sax PE, Libutti DE, Gerschenson M. Changes in fat mitochondrial DNA and function in subjects randomized to abacavir-lamivudine or tenofovir DF-emtricitabine with atazanavir-ritonavir or efavirenz: AIDS Clinical Trials Group study A5224s, substudy of A5202. J Infect Dis. 2013 Feb 15;207(4):604-11. doi: 10.1093/infdis/jis720. Epub 2012 Nov 29. |
| 23148287 | Derived | Mollan K, Daar ES, Sax PE, Balamane M, Collier AC, Fischl MA, Lalama CM, Bosch RJ, Tierney C, Katzenstein D; AIDS Clinical Trials Group Study A5202 Team. HIV-1 amino acid changes among participants with virologic failure: associations with first-line efavirenz or atazanavir plus ritonavir and disease status. J Infect Dis. 2012 Dec 15;206(12):1920-30. doi: 10.1093/infdis/jis613. Epub 2012 Nov 12. |
| 21690627 | Derived | McComsey GA, Kitch D, Sax PE, Tebas P, Tierney C, Jahed NC, Myers L, Melbourne K, Ha B, Daar ES. Peripheral and central fat changes in subjects randomized to abacavir-lamivudine or tenofovir-emtricitabine with atazanavir-ritonavir or efavirenz: ACTG Study A5224s. Clin Infect Dis. 2011 Jul 15;53(2):185-96. doi: 10.1093/cid/cir324. |
| 21606537 | Derived | McComsey GA, Kitch D, Daar ES, Tierney C, Jahed NC, Tebas P, Myers L, Melbourne K, Ha B, Sax PE. Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavir-lamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: Aids Clinical Trials Group A5224s, a substudy of ACTG A5202. J Infect Dis. 2011 Jun 15;203(12):1791-801. doi: 10.1093/infdis/jir188. |
| 21320923 | Derived | Daar ES, Tierney C, Fischl MA, Sax PE, Mollan K, Budhathoki C, Godfrey C, Jahed NC, Myers L, Katzenstein D, Farajallah A, Rooney JF, Pappa KA, Woodward WC, Patterson K, Bolivar H, Benson CA, Collier AC; AIDS Clinical Trials Group Study A5202 Team. Atazanavir plus ritonavir or efavirenz as part of a 3-drug regimen for initial treatment of HIV-1. Ann Intern Med. 2011 Apr 5;154(7):445-56. doi: 10.7326/0003-4819-154-7-201104050-00316. Epub 2011 Feb 14. |
| 19952143 | Derived | Sax PE, Tierney C, Collier AC, Fischl MA, Mollan K, Peeples L, Godfrey C, Jahed NC, Myers L, Katzenstein D, Farajallah A, Rooney JF, Ha B, Woodward WC, Koletar SL, Johnson VA, Geiseler PJ, Daar ES; AIDS Clinical Trials Group Study A5202 Team. Abacavir-lamivudine versus tenofovir-emtricitabine for initial HIV-1 therapy. N Engl J Med. 2009 Dec 3;361(23):2230-40. doi: 10.1056/NEJMoa0906768. Epub 2009 Dec 1. |
| FG002 | RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks |
| FG003 | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
| Initiated Treatment |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EFV, FTC/TDF, and Placebo ABC/3TC | Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks |
| BG001 | EFV, Placebo FTC/TDF, and ABC/3TC | Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
| BG002 | RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks |
| BG003 | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Race/Ethnicity is collected prior to study entry, participants may opt out of reporting. | Number | participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline HIV-1 RNA | Baseline RNA is calculated as the mean of the log10 pre-entry and entry values | Mean | Standard Deviation | log10 copies/mL |
| ||||||||||||||
| Screening HIV-1 RNA | Number | participants |
| ||||||||||||||||
| Baseline CD4+ count | Baseline CD4 count is the average (mean) of 2 measures taken at pre-entry and entry visits. | Median | Inter-Quartile Range | cells/mm3 |
|
| 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 | Time From Randomization to Virologic Failure | Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure. | Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen. | Posted | Number | 95% Confidence Interval | Weeks | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
|
|
| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Amount of Study Follow-up | Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact. | Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen. | Posted | Median | Inter-Quartile Range | Weeks | Follow-up time was variable, median follow-up was 138 weeks |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Virologic Failure | Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. | Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen. | Posted | Number | participants | Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification) | Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. | Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen. | Posted | Number | 95% Confidence Interval | Weeks | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL | Intention to treat: All participants with RNA data were included, complete-case approach. | Posted | Number | Participants | At Weeks 48 and 96 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL | Intention to treat: All participants with RNA data were included, complete-case approach. | Posted | Number | Participants | At Weeks 48 and 96 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in CD4 Count (Cells/mm3) From Baseline | Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values). | Intention to treat: All participants with CD4 data were included, complete-case approach. | Posted | Median | Inter-Quartile Range | Cells/mm3 | At Weeks 48 and 96 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Virologic Failure and Emergence of Major Resistance | Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease. | Intention to treat: All eligible participants are included. Participants were analyzed per originally assigned regimen. | Posted | Number | participants | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events. | AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details. | Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen. | Posted | Number | Participants | Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Total Cholesterol Level From Baseline | Only fasting results are included. The protocol did not require that samples be collected fasting. | Intention to treat: All participants with fasting lipids data were included, complete-case approach. | Posted | Median | Inter-Quartile Range | mg/dL | At Weeks 48 and 96 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline | Only fasting results are included. The protocol did not require that samples be collected fasting. | Intention to treat: All participants with fasting lipids data were included, complete-case approach. | Posted | Median | Inter-Quartile Range | mg/dL | At Weeks 48 and 96 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline | Only fasting results are included. The protocol did not require that samples be collected fasting. | Intention to treat: All participants with fasting lipids data were included, complete-case approach. | Posted | Median | Inter-Quartile Range | mg/dL | At Weeks 48 and 96 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Time From Treatment Dispensation to a Grade 3/4 Safety Event | Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. | As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period. | Posted | Number | 95% Confidence Interval | Weeks | All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks. |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cumulative Probability of Not Experiencing Virologic Failure | Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. | Intention to treat: All eligible participants were included in the analysis, participants were analyzed per originally assigned regimen. | Posted | Number | 95% Confidence Interval | percentage of participants | At week 48 and 96 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Time From Treatment Dispensation to Treatment Modification | Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. | Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen. | Posted | Number | 95% Confidence Interval | Weeks | Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With a Grade 3/4 Safety Event | Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. | As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period. | Posted | Number | participants | Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event | Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded. | As-treated: Participants who initiated treatment are included in this analysis. Follow-up while on initially assigned treatment is included in the at-risk period. | Posted | Number | 95% Confidence Interval | percentage of participants | At week 48 and 96 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Treatment Modification | Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. | Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen. | Posted | Number | participants | Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cumulative Probability of Not Experiencing Treatment Modification | Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. | Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen. | Posted | Number | 95% Confidence Interval | percentage of participants | At week 48 and 96 |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Regimen Failure | Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. | Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen. | Posted | Number | participants | Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cumulative Probability of Not Experiencing Regimen Failure | Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution. | Participants who initiated treatment are included in this analysis. Participants were analyzed per originally assigned regimen. | Posted | Number | 95% Confidence Interval | percentage of participants | At week 48 and 96 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Triglyceride Level From Baseline | Only fasting results are included. The protocol did not require that samples be collected fasting. | Intention to treat: All participants with fasting lipids data were included, complete-case approach. | Posted | Median | Inter-Quartile Range | mg/dL | At Weeks 48 and 96 |
|
From treatment dispensation until off-study, participant follow-up time was variable. Median follow-up was 138 weeks, see 'Amount of study follow-up' for more details.
Grade≥2 CNS, nausea, diarrhea & other Grade>3 signs/symptoms (S/Sx). Diagnoses per ACTG criteria for clinical events & diseases. All Creatinine, bilirubin, fasting lipid & glucose, and other Grade>3 labs. All S/Sx or labs that lead to a change in study treatment. See DAIDS Grading Severity of AEs, V1.0, Dec04, http://rcc.tech-res-intl.com
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 | EFV, FTC/TDF, and Placebo ABC/3TC | Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks | 48 | 461 | 434 | 461 | ||
| EG001 | EFV, Placebo FTC/TDF, and ABC/3TC | Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks | 62 | 461 | 433 | 461 | ||
| EG002 | RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC | Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks | 58 | 464 | 453 | 464 | ||
| EG003 | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks | 71 | 462 | 461 | 462 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 |
| ||
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 |
| ||
| Accidental death | General disorders | MedDRA 13.1 |
| ||
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 |
| ||
| Adenomyosis | Reproductive system and breast disorders | MedDRA 13.1 |
| ||
| Adverse drug reaction | General disorders | MedDRA 13.1 |
| ||
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 |
| ||
| Altered state of consciousness | Nervous system disorders | MedDRA 13.1 |
| ||
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 |
| ||
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
| ||
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 |
| ||
| Blood alkaline phosphatase increased | Investigations | MedDRA 13.1 |
| ||
| Blood bilirubin increased | Investigations | MedDRA 13.1 |
| ||
| Blood creatinine increased | Investigations | MedDRA 13.1 |
| ||
| Blood triglycerides | Investigations | MedDRA 13.1 |
| ||
| Blood triglycerides increased | Investigations | MedDRA 13.1 |
| ||
| Burkitt's lymphoma | Blood and lymphatic system disorders | MedDRA 13.1 |
| ||
| Burkitt's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
| ||
| Cardio-respiratory arrest | General disorders | MedDRA 13.1 |
| ||
| Cardiovascular disorder | Cardiac disorders | MedDRA 13.1 |
| ||
| Cellulitis | Infections and infestations | MedDRA 13.1 |
| ||
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 |
| ||
| Chest pain | General disorders | MedDRA 13.1 |
| ||
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.1 |
| ||
| Clostridium difficile colitis | Infections and infestations | MedDRA 13.1 |
| ||
| Completed suicide | Psychiatric disorders | MedDRA 13.1 |
| ||
| Convulsion | Nervous system disorders | MedDRA 13.1 |
| ||
| Coronary artery disease | Cardiac disorders | MedDRA 13.1 |
| ||
| Death | General disorders | MedDRA 13.1 |
| ||
| Demyelinating polyneuropathy | Nervous system disorders | MedDRA 13.1 |
| ||
| Depression | Psychiatric disorders | MedDRA 13.1 |
| ||
| Depression suicidal | Psychiatric disorders | MedDRA 13.1 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 |
| ||
| Dizziness | Nervous system disorders | MedDRA 13.1 |
| ||
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
| ||
| Drug hypersensitivity | Immune system disorders | MedDRA 13.1 |
| ||
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 13.1 |
| ||
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 |
| ||
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
| ||
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
| ||
| Gastroenteritis | Infections and infestations | MedDRA 13.1 |
| ||
| HIV infection | Infections and infestations | MedDRA 13.1 |
| ||
| Headache | Nervous system disorders | MedDRA 13.1 |
| ||
| Hepatitis | Hepatobiliary disorders | MedDRA 13.1 |
| ||
| Hepatitis C | Infections and infestations | MedDRA 13.1 |
| ||
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
| ||
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.1 |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 |
| ||
| Hypersensitivity | Immune system disorders | MedDRA 13.1 |
| ||
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 13.1 |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.1 |
| ||
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 13.1 |
| ||
| Inflammatory carcinoma of the breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
| ||
| Intestinal perforation | Gastrointestinal disorders | MedDRA 13.1 |
| ||
| Intra-uterine death | Pregnancy, puerperium and perinatal conditions | MedDRA 13.1 |
| ||
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 13.1 |
| ||
| Leukopenia | Blood and lymphatic system disorders | MedDRA 13.1 |
| ||
| Lipase increased | Investigations | MedDRA 13.1 |
| ||
| Liver function test abnormal | Investigations | MedDRA 13.1 |
| ||
| Loss of consciousness | Nervous system disorders | MedDRA 13.1 |
| ||
| Lung infection pseudomonal | Infections and infestations | MedDRA 13.1 |
| ||
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
| ||
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 13.1 |
| ||
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.1 |
| ||
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
| ||
| Malaise | General disorders | MedDRA 13.1 |
| ||
| Meningitis cryptococcal | Infections and infestations | MedDRA 13.1 |
| ||
| Mental status changes | Psychiatric disorders | MedDRA 13.1 |
| ||
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
| ||
| Multiple drug overdose | Injury, poisoning and procedural complications | MedDRA 13.1 |
| ||
| Mycobacterium avium complex infection | Infections and infestations | MedDRA 13.1 |
| ||
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 |
| ||
| Narcotic intoxication | Injury, poisoning and procedural complications | MedDRA 13.1 |
| ||
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.1 |
| ||
| Neurotoxicity | Nervous system disorders | MedDRA 13.1 |
| ||
| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 |
| ||
| Neutrophil count decreased | Investigations | MedDRA 13.1 |
| ||
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
| ||
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 |
| ||
| Ovarian mass | Reproductive system and breast disorders | MedDRA 13.1 |
| ||
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.1 |
| ||
| Pain | General disorders | MedDRA 13.1 |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
| ||
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.1 |
| ||
| Pericarditis | Cardiac disorders | MedDRA 13.1 |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 13.1 |
| ||
| Personality change | Psychiatric disorders | MedDRA 13.1 |
| ||
| Pharyngitis | Infections and infestations | MedDRA 13.1 |
| ||
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA 13.1 |
| ||
| Pneumonia | Infections and infestations | MedDRA 13.1 |
| ||
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
| ||
| Psychotic disorder | Psychiatric disorders | MedDRA 13.1 |
| ||
| Pyrexia | General disorders | MedDRA 13.1 |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
| ||
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 13.1 |
| ||
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 13.1 |
| ||
| Status epilepticus | Nervous system disorders | MedDRA 13.1 |
| ||
| Suicidal ideation | Psychiatric disorders | MedDRA 13.1 |
| ||
| Suicide attempt | Psychiatric disorders | MedDRA 13.1 |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 |
| ||
| Transaminases increased | Investigations | MedDRA 13.1 |
| ||
| Transient global amnesia | Nervous system disorders | MedDRA 13.1 |
| ||
| VIIth nerve paralysis | Nervous system disorders | MedDRA 13.1 |
| ||
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA 13.1 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal dreams | Psychiatric disorders | MedDRA 13.1 |
| ||
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 |
| ||
| Aspartate aminotransferase increased | Investigations | MedDRA 13.1 |
| ||
| Blood bilirubin increased | Investigations | MedDRA 13.1 |
| ||
| Blood cholesterol | Investigations | MedDRA 13.1 |
| ||
| Blood cholesterol abnormal | Investigations | MedDRA 13.1 |
| ||
| Blood creatinine increased | Investigations | MedDRA 13.1 |
| ||
| Blood glucose abnormal | Investigations | MedDRA 13.1 |
| ||
| Blood glucose decreased | Investigations | MedDRA 13.1 |
| ||
| Blood phosphorus decreased | Investigations | MedDRA 13.1 |
| ||
| Blood sodium decreased | Investigations | MedDRA 13.1 |
| ||
| Blood triglycerides | Investigations | MedDRA 13.1 |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 |
| ||
| Depression | Psychiatric disorders | MedDRA 13.1 |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 |
| ||
| Dizziness | Nervous system disorders | MedDRA 13.1 |
| ||
| Drug hypersensitivity | Immune system disorders | MedDRA 13.1 |
| ||
| Fatigue | General disorders | MedDRA 13.1 |
| ||
| Haemoglobin decreased | Investigations | MedDRA 13.1 |
| ||
| Headache | Nervous system disorders | MedDRA 13.1 |
| ||
| Hypertension | Vascular disorders | MedDRA 13.1 |
| ||
| Insomnia | Psychiatric disorders | MedDRA 13.1 |
| ||
| Low density lipoprotein | Investigations | MedDRA 13.1 |
| ||
| Low density lipoprotein abnormal | Investigations | MedDRA 13.1 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 13.1 |
| ||
| Neutrophil count decreased | Investigations | MedDRA 13.1 |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 |
| ||
| Platelet count decreased | Investigations | MedDRA 13.1 |
| ||
| Pyrexia | General disorders | MedDRA 13.1 |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
| ||
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 |
| ||
| White blood cell count decreased | Investigations | MedDRA 13.1 |
|
HIV-1 drug resistance testing and HLA-B*5701 testing were not standard of care during enrollment. EFV and RTV-boosted ATV were open-label, and blinded FTC/TDF vs. ABC/3TC were unblinded in the >=100,000 cp/mL screening viral load stratum Feb 2008.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ACTG ClinicalTrials.gov Coordinator | ACTG Network Coordinating Center, Social and Scientific Systems, Inc. | (301) 628-3313 | ACTGCT.Gov@s-3.com |
| 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 |
|---|---|
| C492871 | abacavir, lamivudine drug combination |
| D000069446 | Atazanavir Sulfate |
| C098320 | efavirenz |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D019438 | Ritonavir |
| C106538 | abacavir |
| D000068679 | Emtricitabine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000068698 | Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black Non-Hispanic |
|
| Hispanic (Regardless of Race) |
|
| Asian, Pacific Islander |
|
| Native American, Alaskan Native |
|
| More than One Race |
|
| Unknown |
|
| Puerto Rico |
|
| >=100,000 copies/mL |
|
| 10th percentile time to virologic failure |
|
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
|
|
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC |
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
|
|
| OG003 | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| OG003 | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
|
|
| OG003 |
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC |
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
|
|
|
|
|
|
|
|
| OG003 | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
|
|
| RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC |
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
|
|
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|
| OG003 | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
|
|
| OG003 | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
|
|
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|
Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
|
|
| OG003 | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
|
|
| OG003 | RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC | Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks |
|
|
|
|