Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings
NCT ID: NCT00084136
Last Updated: 2018-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1571 participants
INTERVENTIONAL
2005-05-31
2010-05-31
Brief Summary
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Detailed Description
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\> All participants were randomly assigned to one of three arms, and random allocation was stratified by 2 factors: country, and screening plasma HIV-1 RNA level (\< 100,000 copies/mL versus \>= 100,000 copies/mL). Participants assigned to the ZDV/3TC+EFV arm received lamivudine/zidovudine twice daily and efavirenz once daily. Participants assigned to the ddI+FTC+ATV arm received emtricitabine, atazanavir, and enteric-coated didanosine once daily. Participants assigned to the TDF/FTC+EFV arm received emtricitabine, tenofovir disoproxil fumarate, and efavirenz once daily. \>
\>
\> Physical exam and blood collection occurred at entry and at most study visits. Participants experiencing virologic failure were offered a switch to another regimen. \>
\> On May 23, 2008, the ddI+FTC+ATV was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that this arm had significantly more virologic failure (and therefore was inferior when) compared to the ZDV/3TC+EFV arm . Participants still receiving ddI+FTC+ATV were offered alternative medications, and all participants continued to be followed. \>
\> On November 3, 2009, the DSMB recommended that the study close to all follow-up on May 31, 2010, before the designed termination (based on 30% of participants meeting the primary outcome) was met. The board observed that the recent accumulation of primary efficacy events (i.e. regimen failures) was very slow. Therefore, if the study were to continue another 1-2 years, the precision gained for treatment comparisons would likely be small.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ZDV/3TC+EFV
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
Efavirenz
600 mg taken orally daily
Lamivudine/Zidovudine
150 mg/300 mg taken orally twice daily
ddI+FTC+ATV
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
Atazanavir
400 mg taken orally daily
Didanosine (enteric-coated)
400 mg taken orally daily
Emtricitabine
200 mg taken orally daily
TDF/FTC+EFV
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Efavirenz
600 mg taken orally daily
Emtricitabine/Tenofovir disoproxil fumarate
200 mg/300 mg taken orally once daily
Interventions
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Atazanavir
400 mg taken orally daily
Didanosine (enteric-coated)
400 mg taken orally daily
Efavirenz
600 mg taken orally daily
Emtricitabine
200 mg taken orally daily
Emtricitabine/Tenofovir disoproxil fumarate
200 mg/300 mg taken orally once daily
Lamivudine/Zidovudine
150 mg/300 mg taken orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* CD4 count fewer than 300 cells/mm3 \>
* Viral load test result\>
* Absolute Neutrophil Count at least 750mm3 \>
* Hemoglobin at least 7.5 g/dL\>
* Platelet count at least 50,000/mm3\>
* Calculated creatinine clearance at least 60 mL/min\>
* A , A, and alkaline phosphatase \<= 5 times upper limit of normal\>
* total bilirubin \<= 2.5 times upper limit of normal\>
* Karnofsky performance score of 70 or higher\>
* Plans to stay in the area for the duration of the study\>
* Agrees to use acceptable forms of contraception for the duration of the study\>
Exclusion Criteria
* Acute therapy for serious medical illnesses within 14 days prior to study entry\>
* Certain abnormal laboratory values\>
* Radiation therapy or chemotherapy within 45 days prior to study entry. \>
* Any immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry. \>
* Current alcohol or drug abuse that, in the opinion of the site investigator, would interfere with study participation\>
* Inflamed pancreas within 3 years prior to study entry\>
* Allergy/sensitivity to any of the study drugs or their formulations\>
* Heart rate less than 40 beats/min\>
* History of untreated, active second- or third-degree heart block\>
* Currently detained in jail or for treatment of a psychiatric or physical illness\>
* Vomiting or inability to swallow medications\>
* Pregnancy\>
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
Responsible Party
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Principal Investigators
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Thomas B. Campbell, MD
Role: STUDY_CHAIR
University of Colorado, Denver
Timothy Flanigan, MD
Role: STUDY_CHAIR
The Miriam Hospital
James Hakim, MscClinEpi, FRCP
Role: STUDY_CHAIR
Department of Medicine, University of Zimbabwe
Nagalingeswaran Kumarasamy, MD
Role: STUDY_CHAIR
Centre for AIDS Research and Education
Locations
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University of Southern California
Los Angeles, California, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Harbor General/UCLA
Torrance, California, United States
Univ. of Colorado Health Sciences Center, Denver
Denver, Colorado, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Rush-Presbyterian/St. Lukes (Chicago)
Chicago, Illinois, United States
Cook County Hospital Core Center
Chicago, Illinois, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University (St. Louis)
St Louis, Missouri, United States
HIV Prevention & Treatment CRS
HVTN 722 West 168th Street MSPH Bldg., New York, United States
Beth Israel Medical Center
New York, New York, United States
Cornell CRS
New York, New York, United States
NY Univ. HIV/AIDS CRS
New York, New York, United States
Community Health Network, Inc.
Rochester, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Wake County Health and Human Services Clinical Research Site
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
Stanley Street Treatment and Resource
Providence, Rhode Island, United States
The Miriam Hosp. ACTG CRS
Providence, Rhode Island, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States
University of Texas, Southwestern Medical Center
Dallas, Texas, United States
University of Texas, Galveston
Galveston, Texas, United States
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Manguinhos, Rio de Janeiro, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Les Centres GHESKIO CRS
Bicentenaire, Port-au-Prince, Haiti
YRG CARE Medical Ctr., VHS Chennai CRS
Rajiv Gandhi Salai Taramani, Chennai, India
NARI Pune CRS
Pune, Maharashtra, India
NARI Clinic at NIV CRS
Maharashtra State, Pune, India
Dr. Kotnis Dispensary
Pune, , India
College of Med. JHU CRS
P.O. Box 1131, Blantyre, Malawi
University of North Carolina Lilongwe CRS
Mzimba Road, Lilongwe, Malawi
Asociacion Civil Impacta Salud y Educacion - Miraf CRS
Barranco, Lima region, Peru
San Miguel CRS
San Miguel, Lima region, Peru
Wits HIV CRS
Johannesburg, Gauteng, South Africa
Durban Adult HIV CRS
Durban, KwaZulu-Natal, South Africa
Chiang Mai Univ. ACTG CRS
P.O. Box 80, Chiang Mai, Thailand
UZ-Parirenyatwa CRS
AIDS Research Unit P.O. Box A178, Harare, Zimbabwe
Countries
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References
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Bartlett JA, Johnson J, Herrera G, Sosa N, Rodriguez A, Liao Q, Griffith S, Irlbeck D, Shaefer MS; Clinically Significant Long-Term Antiretroviral Sequential Sequencing Study (CLASS) Team. Long-term results of initial therapy with abacavir and Lamivudine combined with Efavirenz, Amprenavir/Ritonavir, or Stavudine. J Acquir Immune Defic Syndr. 2006 Nov 1;43(3):284-92. doi: 10.1097/01.qai.0000243092.40490.26.
Saag MS. Initiation of antiretroviral therapy: implications of recent findings. Top HIV Med. 2004 Jul-Aug;12(3):83-8.
Tapper ML, Daar ES, Piliero PJ, Smith K, Steinhart C. Strategies for initiating combination antiretroviral therapy. AIDS Patient Care STDS. 2005 Apr;19(4):224-38. doi: 10.1089/apc.2005.19.224.
Gatechompol S, Zheng L, Bao Y, Avihingsanon A, Kerr SJ, Kumarasamy N, Hakim JG, Maldarelli F, Gorelick RJ, Welker JL, Lifson JD, Hosseinipour MC, Eron JJ, Ruxrungtham K. Prevalence and risk of residual viremia after ART in low- and middle-income countries: A cross-sectional study. Medicine (Baltimore). 2021 Sep 3;100(35):e26817. doi: 10.1097/MD.0000000000026817.
Firnhaber C, Smeaton LM, Grinsztejn B, Lalloo U, Faesen S, Samaneka W, Infante R, Rana A, Kumarasamy N, Hakim J, Campbell TB. Differences in antiretroviral safety and efficacy by sex in a multinational randomized clinical trial. HIV Clin Trials. 2015 May-Jun;16(3):89-99. doi: 10.1179/1528433614Z.0000000013. Epub 2015 May 15.
Kantor R, Smeaton L, Vardhanabhuti S, Hudelson SE, Wallis CL, Tripathy S, Morgado MG, Saravanan S, Balakrishnan P, Reitsma M, Hart S, Mellors JW, Halvas E, Grinsztejn B, Hosseinipour MC, Kumwenda J, La Rosa A, Lalloo UG, Lama JR, Rassool M, Santos BR, Supparatpinyo K, Hakim J, Flanigan T, Kumarasamy N, Campbell TB, Eshleman SH; AIDS Clinical Trials Group (ACTG) A5175 Study Team. Pretreatment HIV Drug Resistance and HIV-1 Subtype C Are Independently Associated With Virologic Failure: Results From the Multinational PEARLS (ACTG A5175) Clinical Trial. Clin Infect Dis. 2015 May 15;60(10):1541-9. doi: 10.1093/cid/civ102. Epub 2015 Feb 13.
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.
Campbell TB, Smeaton LM, Kumarasamy N, Flanigan T, Klingman KL, Firnhaber C, Grinsztejn B, Hosseinipour MC, Kumwenda J, Lalloo U, Riviere C, Sanchez J, Melo M, Supparatpinyo K, Tripathy S, Martinez AI, Nair A, Walawander A, Moran L, Chen Y, Snowden W, Rooney JF, Uy J, Schooley RT, De Gruttola V, Hakim JG; PEARLS study team of the ACTG. Efficacy and safety of three antiretroviral regimens for initial treatment of HIV-1: a randomized clinical trial in diverse multinational settings. PLoS Med. 2012;9(8):e1001290. doi: 10.1371/journal.pmed.1001290. Epub 2012 Aug 14.
Nielsen-Saines K, Komarow L, Cu-Uvin S, Jourdain G, Klingman KL, Shapiro DE, Mofenson L, Moran L, Campbell TB, Hitti J, Fiscus S, Currier J; ACTG 5190/PACTG 1054 Study Team. Infant outcomes after maternal antiretroviral exposure in resource-limited settings. Pediatrics. 2012 Jun;129(6):e1525-32. doi: 10.1542/peds.2011-2340. Epub 2012 May 14.
Safren SA, Hendriksen ES, Smeaton L, Celentano DD, Hosseinipour MC, Barnett R, Guanira J, Flanigan T, Kumarasamy N, Klingman K, Campbell T. Quality of life among individuals with HIV starting antiretroviral therapy in diverse resource-limited areas of the world. AIDS Behav. 2012 Feb;16(2):266-77. doi: 10.1007/s10461-011-9947-5.
Firnhaber C, Smeaton L, Saukila N, Flanigan T, Gangakhedkar R, Kumwenda J, La Rosa A, Kumarasamy N, De Gruttola V, Hakim JG, Campbell TB. Comparisons of anemia, thrombocytopenia, and neutropenia at initiation of HIV antiretroviral therapy in Africa, Asia, and the Americas. Int J Infect Dis. 2010 Dec;14(12):e1088-92. doi: 10.1016/j.ijid.2010.08.002. Epub 2010 Oct 18.
Other Identifiers
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PEARLS
Identifier Type: -
Identifier Source: secondary_id
A5185s
Identifier Type: -
Identifier Source: secondary_id
ACTG A5175
Identifier Type: -
Identifier Source: org_study_id
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