AzTrials
AzTrials

HIV InfectionsPhase 3NCT00118898

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

A Phase 3 study testing Abacavir/Lamivudine, Atazanavir and Efavirenz in people with HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
HIV Infections
What is being tested?
Abacavir/Lamivudine, Atazanavir and Efavirenz
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,864 participants
Where
52 sitesin 2 countries
Study dates
Sep 2005to Nov 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

United States51 sites

  • Emory University

    Atlanta, Georgia, 30308

  • The Ponce de Leon Center CRS (5802)

    Atlanta, Georgia, 30308

  • University of Colorado Hospital CRS (6101)

    Aurora, Colorado, 80045

  • IHV Baltimore Treatment CRS (4651)

    Baltimore, Maryland, 21201

  • Johns Hopkins Adult AIDS CRS (201)

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital ACTG CRS (101)

    Boston, Massachusetts, 02114

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

    Boston, Massachusetts, 02115

  • Bmc Actg Crs (104)

    Boston, Massachusetts, 02118

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

    Boston, Massachusetts, 02215

  • SUNY - Buffalo (Rochester) (1102)

    Buffalo, New York, 14215

  • Unc Aids Crs (3201)

    Chapel Hill, North Carolina, 27514

  • Wake County Department of Health (30076)

    Chapel Hill, North Carolina, 27514

  • Northwestern University CRS (2701)

    Chicago, Illinois, 60611

  • Cook County Hospital Core Center (2705)

    Chicago, Illinois, 60612

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

    Chicago, Illinois, 60612

  • University of Cincinnati CRS (2401)

    Cincinnati, Ohio, 45267

  • Case CRS (2501)

    Cleveland, Ohio, 44106

  • Metro Health CRS (2503)

    Cleveland, Ohio, 44109

  • The Ohio State Univ. AIDS CRS (2301)

    Columbus, Ohio, 43210

  • Peabody Health Center CRS (31443)

    Dallas, Texas, 75215

  • Duke University Medical Center Adult CRS (1601)

    Durham, North Carolina, 27710

  • University of Texas, Galveston (6301)

    Galveston, Texas, 77555-0435

  • Moses H. Cone Memorial Hospital CRS (3203)

    Greensboro, North Carolina, 27401

  • Indiana University Hospital (2601)

    Indianapolis, Indiana, 46202-5250

  • Wishard Hospital (2603)

    Indianapolis, Indiana, 46202

  • Univ of Iowa Hosp and Clinic (1504)

    Iowa City, Iowa, 52242

  • Usc Crs (1201)

    Los Angeles, California, 90033

  • UCLA CARE Center CRS (601)

    Los Angeles, California, 90035

  • University of Miami AIDS CRS (901)

    Miami, Florida, 33139

  • Vanderbilt Therapeutics CRS (3652)

    Nashville, Tennessee, 37232

  • Cornell CRS (7804)

    New York, New York, 10011

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

    New York, New York, 10011

  • NY Univ. HIV/AIDS CRS (401)

    New York, New York, 10016

  • HIV Prevention & Treatment CRS (30329)

    New York, New York, 10032

  • Harlem ACTG CRS (31483)

    New York, New York, 10037

  • Presbyterian Medical Center - Univ. of PA (6206)

    Norristown, Pennsylvania, 19401

  • Stanford CRS (501)

    Palo Alto, California, 94304

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

    Philadelphia, Pennsylvania, 19104

  • Pitt CRS (1001)

    Pittsburgh, Pennsylvania, 15213

  • The Miriam Hosp. ACTG CRS (2951)

    Providence, Rhode Island, 02906

  • AIDS Community Health Ctr. ACTG CRS (1108)

    Rochester, New York, 14604

  • University of Rochester ACTG CRS (1101)

    Rochester, New York, 14642

  • Ucsd, Avrc Crs (701)

    San Diego, California, 92103

  • Ucsf Aids Crs (801)

    San Francisco, California, 94110

  • University of Washington AIDS CRS (1401)

    Seattle, Washington, 98104

  • University of Washington General Clinical Research (1403)

    Seattle, Washington, 98104

  • Washington U CRS (2101)

    St Louis, Missouri, 63110

  • San Mateo County AIDS Program (505)

    Stanford, California, 94305-5107

  • Willow Clinic (507)

    Stanford, California, 94305-5107

  • Harbor-UCLA Med. Ctr. CRS (603)

    Torrance, California, 90502

  • Georgetown University CRS (GU CRS) (1008)

    Washington D.C., District of Columbia, 20007

Other trials in United States

Puerto Rico1 site

  • Puerto Rico-AIDS CRS (5401)

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects

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.

Read the detailed description

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:

  • Arm 1 participants will receive EFV, FTC/TDF, and placebo for ABC/3TC.
  • Arm 2 participants will receive EFV, ABC/3TC, and placebo for FTC/TDF.
  • Arm 3 participants will receive ritonavir (RTV)-boosted ATV, FTC/TDF, and placebo for ABC/3TC.
  • Arm 4 participants will receive RTV-boosted ATV, ABC/3TC and placebo for FTC/TDF.

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).

Conditions
HIV Infections
Being tested
Abacavir/Lamivudine, Atazanavir, Efavirenz, Emtricitabine/Tenofovir disoproxil fumarate, Ritonavir
Keywords
Treatment Naive
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abacavir/LamivudineDrug

    Also called ABC/3TC

    600 mg abacavir/300 mg lamivudine tablet taken orally daily

  • AtazanavirDrug

    Also called ATV

    300 mg tablet taken orally daily

  • EfavirenzDrug

    Also called EFV

    600 mg tablet taken orally daily

  • Emtricitabine/Tenofovir disoproxil fumarateDrug

    Also called FTC/TDF

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

  • RitonavirDrug

    Also called RTV

    100 mg tablet taken orally daily

  • Abacavir/Lamivudine placeboDrug

    Also called ABC/3TC placebo

    Placebo tablet taken orally daily

  • Emtricitabine/Tenofovir disoproxil fumarate placeboDrug

    Also called FTC/TDF placebo

    Placebo tablet taken orally daily

Study groups in NCT00118898
Study groupRoleWhat they receive
EFV, FTC/TDF, and placebo ABC/3TCExperimentalParticipants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Receives: Drug: Efavirenz; Drug: Emtricitabine/Tenofovir disoproxil fumarate; Drug: Abacavir/Lamivudine placebo
EFV, ABC/3TC and placebo FTC/TDFExperimentalParticipants will receive EFV, ABC/3TC, and placebo for FTC/TDF for at least 96 weeks
Receives: Drug: Abacavir/Lamivudine; Drug: Efavirenz; Drug: Emtricitabine/Tenofovir disoproxil fumarate placebo
RTV-boosted ATV, FTC/TDF, and placebo ABC/3TCExperimentalParticipants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
Receives: Drug: Atazanavir; Drug: Emtricitabine/Tenofovir disoproxil fumarate; Drug: Ritonavir; Drug: Abacavir/Lamivudine placebo
RTV-boosted ATV, ABC/3TC, and placebo FTC/TDFExperimentalParticipants will receive RTV-boosted ATV, ABC/3TC, and placebo for FTC/TDF for at least 96 weeks
Receives: Drug: Abacavir/Lamivudine; Drug: Atazanavir; Drug: Ritonavir; Drug: Emtricitabine/Tenofovir disoproxil fumarate placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 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.

  3. 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.

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

Secondary outcomes (10)

  1. 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.

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

  2. The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

    Measured: At Weeks 48 and 96

  3. Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL

    Measured: At Weeks 48 and 96

  4. 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).

    Measured: At Weeks 48 and 96

  5. 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.

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

  6. 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.

    http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm

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

  7. Change in Fasting Total Cholesterol Level From Baseline

    Only fasting results are included. The protocol did not require that samples be collected fasting.

    Measured: At Weeks 48 and 96

  8. 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.

    Measured: At Weeks 48 and 96

  9. 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.

    Measured: At Weeks 48 and 96

  10. Change in Fasting Triglyceride Level From Baseline

    Only fasting results are included. The protocol did not require that samples be collected fasting.

    Measured: At Weeks 48 and 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionNov 2009
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,864 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00118898
Sponsor's protocol ID
ACTG A5202
Other IDs
1U01AI068636, ACTG 5224s
Status last verified
Sep 2018
First submitted
7 Jul 2005
Last updated
12 Oct 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15479772

  • 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.

    PubMed 15503932

  • 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.

    PubMed 14668455

  • 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.

    PubMed 14668456

  • 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.

    PubMed 38160309

  • 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.

    PubMed 33901188

  • 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.

    PubMed 32829410

  • 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.

    PubMed 30642925

  • 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.

    PubMed 26009829

  • 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.

    PubMed 24979445

  • 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.

    PubMed 24872136

  • 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.

    PubMed 24637543

  • 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.

    PubMed 24384588

  • 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.

    PubMed 24253247

  • 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.

    PubMed 23204164

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abacavir/Lamivudine, Atazanavir and Efavirenz in people with HIV Infections, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Randomization to Virologic Failure (time frame: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00118898, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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