- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00084136
Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings (PEARLS)
Randomized, Open-Label Evaluation of Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Persons From Resource-Limited Settings (PEARLS) Trial
Study Overview
Status
Conditions
Detailed Description
In developed countries, standard effective antiretroviral (ARV) therapy for treatment-naive HIV infected people includes three-drug combinations of two nucleoside reverse transcriptase inhibitors (NRTIs) with either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI). However, direct comparisons of ARV efficacy in persons that more closely reflect the worldwide demographics of HIV-1 infection are needed.> > Trial participants were recruited in Africa (Malawi, South Africa, Zimbabwe), Asia (India, Thailand), South America (Brazil, Peru), Haiti, and the United States.>
> 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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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RS
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Porto Alegre, RS, Brazil, 91350-200
- Hospital Nossa Senhora da Conceição
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Rio De Janeiro
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Manguinhos, Rio De Janeiro, Brazil
- Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
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Port-au-Prince
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Bicentenaire, Port-au-Prince, Haiti, HT-6110
- Les Centres GHESKIO CRS
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Pune, India, 411026
- Dr. Kotnis Dispensary
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Chennai
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Rajiv Gandhi Salai Taramani, Chennai, India, 600113
- YRG CARE Medical Ctr., VHS Chennai CRS
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Maharashtra
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Pune, Maharashtra, India
- NARI Pune CRS
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Pune
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Maharashtra State, Pune, India
- NARI Clinic at NIV CRS
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Blantyre
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P.O. Box 1131, Blantyre, Malawi
- College of Med. JHU CRS
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Lilongwe
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Mzimba Road, Lilongwe, Malawi
- University of North Carolina Lilongwe CRS
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Lima
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Barranco, Lima, Peru
- Asociacion Civil Impacta Salud y Educacion - Miraf CRS
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San Miguel, Lima, Peru
- San Miguel CRS
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Gauteng
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Johannesburg, Gauteng, South Africa, 2092
- Wits HIV CRS
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KwaZulu Natal
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Durban, KwaZulu Natal, South Africa, 4001
- Durban Adult HIV CRS
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Chiang Mai
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P.O. Box 80, Chiang Mai, Thailand, 50200
- Chiang Mai Univ. ACTG CRS
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California
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Los Angeles, California, United States, 90033-1079
- University of Southern California
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Los Angeles, California, United States, 90095-1793
- UCLA CARE Center CRS
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Torrance, California, United States, 90502-2052
- Harbor General/UCLA
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Colorado
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Denver, Colorado, United States
- Univ. of Colorado Health Sciences Center, Denver
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Hawaii
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Honolulu, Hawaii, United States, 96816-2396
- Univ. of Hawaii at Manoa, Leahi Hosp.
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Illinois
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Chicago, Illinois, United States, 60611-3015
- Northwestern University
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Chicago, Illinois, United States, 60612
- Cook County Hospital Core Center
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Chicago, Illinois, United States, 60612-3806
- Rush-Presbyterian/St. Lukes (Chicago)
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Minnesota
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Minneapolis, Minnesota, United States, 55455-0392
- University of Minnesota
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Missouri
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Saint Louis, Missouri, United States, 63108-2138
- Washington University (St. Louis)
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New York
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HVTN 722 West 168th Street MSPH Bldg., New York, United States, 10032
- HIV Prevention & Treatment CRS
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New York, New York, United States, 10003
- Beth Israel Medical Center
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New York, New York, United States, 10016
- NY Univ. HIV/AIDS CRS
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New York, New York, United States, 10011
- Cornell CRS
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Rochester, New York, United States, 14642-0001
- Univ. of Rochester ACTG CRS
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Rochester, New York, United States, 14642-0001
- Community Health Network, Inc.
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- University of North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Wake County Health and Human Services Clinical Research Site
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45267-0405
- University of Cincinnati
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Columbus, Ohio, United States, 43210
- The Ohio State Univ. AIDS CRS
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hosp. of the Univ. of Pennsylvania CRS
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Rhode Island
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Providence, Rhode Island, United States, 02906
- The Miriam Hosp. ACTG CRS
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Providence, Rhode Island, United States, 02906
- Stanley Street Treatment and Resource
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Tennessee
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Nashville, Tennessee, United States, 37204
- Vanderbilt Therapeutics CRS
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Texas
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Dallas, Texas, United States
- University of Texas, Southwestern Medical Center
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Galveston, Texas, United States, 77555-0435
- University of Texas, Galveston
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Harare
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AIDS Research Unit P.O. Box A178, Harare, Zimbabwe
- UZ-Parirenyatwa CRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria :>
- HIV-1 infected>
- 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:>
- More than 7 days exposure to ARVs (except for single-dose NVP or ZDV for any period for the purpose of pMTCT)>
- 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>
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ZDV/3TC+EFV
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
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600 mg taken orally daily
Other Names:
150 mg/300 mg taken orally twice daily
Other Names:
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Experimental: ddI+FTC+ATV
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
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400 mg taken orally daily
Other Names:
400 mg taken orally daily
Other Names:
200 mg taken orally daily
Other Names:
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Experimental: TDF/FTC+EFV
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
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600 mg taken orally daily
Other Names:
200 mg/300 mg taken orally once daily
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Treatment Failure (PI Comparison)
Time Frame: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).
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Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause).
Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).
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Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).
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Time to Treatment Failure (NRTI Comparison)
Time Frame: Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).
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Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause).
Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).
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Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
Time Frame: Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)
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Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).
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Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)
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Time to Immunologic Failure (PI Comparison)
Time Frame: At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)
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Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.
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At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)
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Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)
Time Frame: weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
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Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).
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weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
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Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)
Time Frame: Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)
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Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline.
Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.
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Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)
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Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)
Time Frame: At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
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Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48.
Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available.
Missing values excluded, and both study treatment status and history ignored.
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At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
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Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)
Time Frame: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
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Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.
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Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
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Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)
Time Frame: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
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Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.
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Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
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Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)
Time Frame: Throughout follow-up until study closed (May 31,2010)
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Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).
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Throughout follow-up until study closed (May 31,2010)
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Time to Immunologic Failure (NRTI Comparison)
Time Frame: At or after Week 48 (including all follow-up through study closure - May 31,2010)
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Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.
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At or after Week 48 (including all follow-up through study closure - May 31,2010)
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Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)
Time Frame: weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)
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Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).
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weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)
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Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)
Time Frame: At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)
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Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48.
Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available.
Missing values excluded, and both study treatment status and history ignored.
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At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)
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Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Time Frame: Week 48 (using follow-up through study closure on May 31,2010)
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Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.
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Week 48 (using follow-up through study closure on May 31,2010)
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Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Time Frame: Week 96 (using follow-up through to study closure on May 31,2010)
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Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.
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Week 96 (using follow-up through to study closure on May 31,2010)
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Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Time Frame: Week 48 using follow-up through study closure on May 31,2010
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Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.
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Week 48 using follow-up through study closure on May 31,2010
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Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Time Frame: Week 96 using follow-up through study closure on May 31,2010
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Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.
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Week 96 using follow-up through study closure on May 31,2010
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Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)
Time Frame: Throughout study follow-up until study closure (May 31, 2010)
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Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline.
Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.
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Throughout study follow-up until study closure (May 31, 2010)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Thomas B. Campbell, MD, University of Colorado, Denver
- Study Chair: Timothy Flanigan, MD, The Miriam Hospital
- Study Chair: James Hakim, MscClinEpi, FRCP, Department of Medicine, University of Zimbabwe
- Study Chair: Nagalingeswaran Kumarasamy, MD, Centre for AIDS Research and Education
Publications and helpful links
General Publications
- 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. Erratum In: Ann Intern Med. 2014 Aug 19;161(4):308.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Tenofovir
- Emtricitabine
- Lamivudine
- Zidovudine
- Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
- Didanosine
- Atazanavir Sulfate
- Efavirenz
- Lamivudine, zidovudine drug combination
Other Study ID Numbers
- ACTG A5175
- 1U01AI068636 (U.S. NIH Grant/Contract)
- 5K24AI051966-03 (U.S. NIH Grant/Contract)
- PEARLS
- A5185s
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
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University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
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Gérond'ifRecruiting
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University of California, DavisCompleted
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University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
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University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
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HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
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University of ZimbabweCompleted
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Florida International UniversityCompleted
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Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Efavirenz
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Institut BergoniéCompletedNon-Hodgkin's Lymphoma | Solid TumorsFrance
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St Stephens Aids TrustViiV HealthcareUnknown
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Herlev HospitalFlexdialysis ApSCompleted
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Shanghai Public Health Clinical CenterNot yet recruitingHIV Infections | Tuberculosis
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University Hospital, Basel, SwitzerlandUniversity of BaselCompletedBiological Availability | Amorphous Solid DispersionsSwitzerland
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Peking Union Medical College HospitalUnknownHIV/AIDS | Mental ImpairmentChina
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Yale UniversityTerminatedSafety of Dialysate Sodium Individualization in Hemodialysis Patients With Intradialytic HypotensionHemodialysis | HypotensionUnited States
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Center for Clinical Pharmacology Research Bdbeq...University of the Republic, UruguayCompleted
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Stanford UniversityTerminatedHIV Infections | TuberculosisBrazil
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Kirby InstituteCompleted