Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults

NCT00118898 | Completed Phase 3 Results DMC

• 3 other identifiers: ACTG A52021U01AI068636ACTG 5224s
• Study Type: interventional
• Target: 1,864
• Locations: 2 countries
• Sites: 52

Brief Summary

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.

Conditions

HIV Infections

Keywords

Treatment Naive

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (10)

• Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)

  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

  At Weeks 48 and 96

• Number of Participants With Virologic Failure and Emergence of Major Resistance

  Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Other Outcomes (9)

• Amount of Study Follow-up

  Follow-up time was variable, median follow-up was 138 weeks

• Number of Participants With Virologic Failure

  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

  At week 48 and 96

Study Arms (4)

EFV, FTC/TDF, and placebo ABC/3TC

EXPERIMENTAL

Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks

Drug: Efavirenz; Drug: Emtricitabine/Tenofovir disoproxil fumarate; Drug: Abacavir/Lamivudine placebo

EFV, ABC/3TC and placebo FTC/TDF

EXPERIMENTAL

Participants will receive EFV, ABC/3TC, and placebo for FTC/TDF for at least 96 weeks

Drug: Abacavir/Lamivudine; Drug: Efavirenz; Drug: Emtricitabine/Tenofovir disoproxil fumarate placebo

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

Drug: Atazanavir; Drug: Emtricitabine/Tenofovir disoproxil fumarate; Drug: Ritonavir; Drug: Abacavir/Lamivudine placebo

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

Drug: Abacavir/Lamivudine; Drug: Atazanavir; Drug: Ritonavir; Drug: Emtricitabine/Tenofovir disoproxil fumarate placebo

Interventions

Abacavir/Lamivudine DRUG

600 mg abacavir/300 mg lamivudine tablet taken orally daily

Also known as: ABC/3TC

EFV, ABC/3TC and placebo FTC/TDF; RTV-boosted ATV, ABC/3TC, and placebo FTC/TDF

Atazanavir DRUG

300 mg tablet taken orally daily

Also known as: ATV

RTV-boosted ATV, ABC/3TC, and placebo FTC/TDF; RTV-boosted ATV, FTC/TDF, and placebo ABC/3TC

Efavirenz DRUG

600 mg tablet taken orally daily

Also known as: EFV

EFV, ABC/3TC and placebo FTC/TDF; EFV, FTC/TDF, and placebo ABC/3TC

Emtricitabine/Tenofovir disoproxil fumarate DRUG

200 mg emtricitabine/300 mg tenofovir disoproxil fumarate tablet taken orally daily

Also known as: FTC/TDF

EFV, FTC/TDF, and placebo ABC/3TC; RTV-boosted ATV, FTC/TDF, and placebo ABC/3TC

Ritonavir DRUG

100 mg tablet taken orally daily

Also known as: RTV

RTV-boosted ATV, ABC/3TC, and placebo FTC/TDF; RTV-boosted ATV, FTC/TDF, and placebo ABC/3TC

Abacavir/Lamivudine placebo DRUG

Placebo tablet taken orally daily

Also known as: ABC/3TC placebo

EFV, FTC/TDF, and placebo ABC/3TC; RTV-boosted ATV, FTC/TDF, and placebo ABC/3TC

Emtricitabine/Tenofovir disoproxil fumarate placebo DRUG

Placebo tablet taken orally daily

Also known as: FTC/TDF placebo

EFV, ABC/3TC and placebo FTC/TDF; RTV-boosted ATV, ABC/3TC, and placebo FTC/TDF

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected. A resistance assay must be obtained if the participant has evidence of recent infection. More information on this criterion can be found in the protocol.
• Antiretroviral naive, defined as 7 days or less of ARV treatment at any time prior to study entry. Participants who have received ARVs as part of postexposure prophylaxis or who have received an investigational drug that was not an NRTI, NNRTI, or PI are eligible for this study.
• HIV viral load greater than 1,000 copies/ml within 90 days prior to study entry
• Certain laboratory values obtained within 30 days prior to study entry. More information on this criterion can be found in the protocol
• Willing to use acceptable forms of contraception
• Parent or guardian able and willing to provide written informed consent, if applicable
• Hepatitis B surface antigen (HBsAg) negative at study entry

You may not qualify if:

• Immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Individuals receiving either stable physiologic glucocorticoid doses, corticosteroids for acute therapy for pneumocystis pneumonia, or a short course (2 weeks or less) of pharmacologic glucocorticoid therapy will not be excluded.
• Known allergy/sensitivity to study drugs or their formulations
• Active alcohol or drug use that, in the opinion of the investigator, would interfere with adherence to study requirements
• Serious illness requiring systemic treatment or hospitalization. Patients who have completed therapy or are clinically stable on therapy for at least 7 days prior to study entry are not excluded.
• Known clinically relevant cardiac conduction system disease
• Requirement for any current medications that are prohibited with any study treatment.
• Evidence of any major drug resistance-associated mutation on any genotype or evidence of significant resistance on any phenotype performed at any time prior to study entry.
• Current imprisonment or involuntary incarceration for psychiatric or physical (e.g., infectious disease) illness
• Breastfeeding. Women who become pregnant during the study will be unblinded and required to permanently discontinue their study regimens.

Sponsors & Collaborators

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (52)

Usc Crs (1201)

Los Angeles, California, 90033, United States

Location

UCLA CARE Center CRS (601)

Los Angeles, California, 90035, United States

Location

Stanford CRS (501)

Palo Alto, California, 94304, United States

Location

Ucsd, Avrc Crs (701)

San Diego, California, 92103, United States

Location

Ucsf Aids Crs (801)

San Francisco, California, 94110, United States

Location

San Mateo County AIDS Program (505)

Stanford, California, 94305-5107, United States

Location

Willow Clinic (507)

Stanford, California, 94305-5107, United States

Location

Harbor-UCLA Med. Ctr. CRS (603)

Torrance, California, 90502, United States

Location

University of Colorado Hospital CRS (6101)

Aurora, Colorado, 80045, United States

Location

Georgetown University CRS (GU CRS) (1008)

Washington D.C., District of Columbia, 20007, United States

Location

University of Miami AIDS CRS (901)

Miami, Florida, 33139, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

The Ponce de Leon Center CRS (5802)

Atlanta, Georgia, 30308, United States

Location

Northwestern University CRS (2701)

Chicago, Illinois, 60611, United States

Location

Cook County Hospital Core Center (2705)

Chicago, Illinois, 60612, United States

Location

Rush Univ. Med. Ctr. ACTG CRS (2702)

Chicago, Illinois, 60612, United States

Location

Indiana University Hospital (2601)

Indianapolis, Indiana, 46202-5250, United States

Location

Wishard Hospital (2603)

Indianapolis, Indiana, 46202, United States

Location

Univ of Iowa Hosp and Clinic (1504)

Iowa City, Iowa, 52242, United States

Location

IHV Baltimore Treatment CRS (4651)

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Adult AIDS CRS (201)

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital ACTG CRS (101)

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hosp. ACTG CRS (107)

Boston, Massachusetts, 02115, United States

Location

Bmc Actg Crs (104)

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS (103)

Boston, Massachusetts, 02215, United States

Location

Washington U CRS (2101)

St Louis, Missouri, 63110, United States

Location

SUNY - Buffalo (Rochester) (1102)

Buffalo, New York, 14215, United States

Location

Cornell CRS (7804)

New York, New York, 10011, United States

Location

Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea (7803)

New York, New York, 10011, United States

Location

NY Univ. HIV/AIDS CRS (401)

New York, New York, 10016, United States

Location

HIV Prevention & Treatment CRS (30329)

New York, New York, 10032, United States

Location

Harlem ACTG CRS (31483)

New York, New York, 10037, United States

Location

AIDS Community Health Ctr. ACTG CRS (1108)

Rochester, New York, 14604, United States

Location

University of Rochester ACTG CRS (1101)

Rochester, New York, 14642, United States

Location

Unc Aids Crs (3201)

Chapel Hill, North Carolina, 27514, United States

Location

Wake County Department of Health (30076)

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center Adult CRS (1601)

Durham, North Carolina, 27710, United States

Location

Moses H. Cone Memorial Hospital CRS (3203)

Greensboro, North Carolina, 27401, United States

Location

University of Cincinnati CRS (2401)

Cincinnati, Ohio, 45267, United States

Location

Case CRS (2501)

Cleveland, Ohio, 44106, United States

Location

Metro Health CRS (2503)

Cleveland, Ohio, 44109, United States

Location

The Ohio State Univ. AIDS CRS (2301)

Columbus, Ohio, 43210, United States

Location

Presbyterian Medical Center - Univ. of PA (6206)

Norristown, Pennsylvania, 19401, United States

Location

Hosp. of the Univ. of Pennsylvania CRS (6201)

Philadelphia, Pennsylvania, 19104, United States

Location

Pitt CRS (1001)

Pittsburgh, Pennsylvania, 15213, United States

Location

The Miriam Hosp. ACTG CRS (2951)

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Therapeutics CRS (3652)

Nashville, Tennessee, 37232, United States

Location

Peabody Health Center CRS (31443)

Dallas, Texas, 75215, United States

Location

University of Texas, Galveston (6301)

Galveston, Texas, 77555-0435, United States

Location

University of Washington AIDS CRS (1401)

Seattle, Washington, 98104, United States

Location

University of Washington General Clinical Research (1403)

Seattle, Washington, 98104, United States

Location

Puerto Rico-AIDS CRS (5401)

San Juan, 00935, Puerto Rico

Location

Related Publications (20)

• 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.

  PMID: 15479772 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.

  PMID: 15503932 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.

  PMID: 14668455 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.

  PMID: 14668456 BACKGROUND

• 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.

  PMID: 38160309 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.

  PMID: 33901188 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.

  PMID: 32829410 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.

  PMID: 30642925 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.

  PMID: 26009829 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.

  PMID: 24979445 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.

  PMID: 24872136 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.

  PMID: 24637543 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.

  PMID: 24384588 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.

  PMID: 24253247 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.

  PMID: 23204164 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.

  PMID: 23148287 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.

  PMID: 21690627 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.

  PMID: 21606537 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.

  PMID: 21320923 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.

  PMID: 19952143 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir, lamivudine drug combination; Atazanavir Sulfate; efavirenz; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Ritonavir; abacavir; Emtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Thiazoles; Sulfur Compounds; Azoles

Limitations and Caveats

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.

Results Point of Contact

• Title: ACTG ClinicalTrials.gov Coordinator
• Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

ACTGCT.Gov@s-3.com

(301) 628-3313

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2005
• First Posted: July 12, 2005
• Study Start: September 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 12, 2018
• Results First Posted: January 10, 2011

Record last verified: 2018-09

Locations

PR (1); US (51)