Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings (PEARLS)
11 сентября 2018 г. обновлено: AIDS Clinical Trials Group
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
This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens.
Participants were recruited from resource-limited areas in Africa, Asia, South America, Haiti, and also from the United States.
The study hypothesis was each of the once daily combinations (PI based, or NNRTI based) would not have inferior efficacy compared to the twice daily NNRTI based combination.
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
1571
Фаза
- Фаза 4
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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RS
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Porto Alegre, RS, Бразилия, 91350-200
- Hospital Nossa Senhora da Conceicao
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Rio De Janeiro
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Manguinhos, Rio De Janeiro, Бразилия
- Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
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Port-au-Prince
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Bicentenaire, Port-au-Prince, Гаити, HT-6110
- Les Centres GHESKIO CRS
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Harare
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AIDS Research Unit P.O. Box A178, Harare, Зимбабве
- UZ-Parirenyatwa CRS
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Pune, Индия, 411026
- Dr. Kotnis Dispensary
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Chennai
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Rajiv Gandhi Salai Taramani, Chennai, Индия, 600113
- YRG CARE Medical Ctr., VHS Chennai CRS
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Maharashtra
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Pune, Maharashtra, Индия
- NARI Pune CRS
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Pune
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Maharashtra State, Pune, Индия
- NARI Clinic at NIV CRS
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Blantyre
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P.O. Box 1131, Blantyre, Малави
- College of Med. JHU CRS
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Lilongwe
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Mzimba Road, Lilongwe, Малави
- University of North Carolina Lilongwe CRS
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Lima
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Barranco, Lima, Перу
- Asociacion Civil Impacta Salud y Educacion - Miraf CRS
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San Miguel, Lima, Перу
- San Miguel CRS
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California
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Los Angeles, California, Соединенные Штаты, 90033-1079
- University of Southern California
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Los Angeles, California, Соединенные Штаты, 90095-1793
- UCLA CARE Center CRS
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Torrance, California, Соединенные Штаты, 90502-2052
- Harbor General/UCLA
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Colorado
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Denver, Colorado, Соединенные Штаты
- Univ. of Colorado Health Sciences Center, Denver
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Hawaii
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Honolulu, Hawaii, Соединенные Штаты, 96816-2396
- Univ. of Hawaii at Manoa, Leahi Hosp.
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Illinois
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Chicago, Illinois, Соединенные Штаты, 60611-3015
- Northwestern University
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Chicago, Illinois, Соединенные Штаты, 60612
- Cook County Hospital Core Center
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Chicago, Illinois, Соединенные Штаты, 60612-3806
- Rush-Presbyterian/St. Lukes (Chicago)
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Minnesota
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Minneapolis, Minnesota, Соединенные Штаты, 55455-0392
- University of Minnesota
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Missouri
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Saint Louis, Missouri, Соединенные Штаты, 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, Соединенные Штаты, 10032
- HIV Prevention & Treatment CRS
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New York, New York, Соединенные Штаты, 10003
- Beth Israel Medical Center
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New York, New York, Соединенные Штаты, 10016
- NY Univ. HIV/AIDS CRS
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New York, New York, Соединенные Штаты, 10011
- Cornell CRS
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Rochester, New York, Соединенные Штаты, 14642-0001
- Univ. of Rochester ACTG CRS
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Rochester, New York, Соединенные Штаты, 14642-0001
- Community Health Network, Inc.
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North Carolina
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Chapel Hill, North Carolina, Соединенные Штаты, 27514
- University of North Carolina
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Chapel Hill, North Carolina, Соединенные Штаты, 27514
- Wake County Health and Human Services Clinical Research Site
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Durham, North Carolina, Соединенные Штаты, 27710
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45267-0405
- University of Cincinnati
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Columbus, Ohio, Соединенные Штаты, 43210
- The Ohio State Univ. AIDS CRS
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- Hosp. of the Univ. of Pennsylvania CRS
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Rhode Island
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Providence, Rhode Island, Соединенные Штаты, 02906
- The Miriam Hosp. ACTG CRS
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Providence, Rhode Island, Соединенные Штаты, 02906
- Stanley Street Treatment and Resource
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Tennessee
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Nashville, Tennessee, Соединенные Штаты, 37204
- Vanderbilt Therapeutics CRS
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Texas
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Dallas, Texas, Соединенные Штаты
- University of Texas, Southwestern Medical Center
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Galveston, Texas, Соединенные Штаты, 77555-0435
- University of Texas, Galveston
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Chiang Mai
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P.O. Box 80, Chiang Mai, Таиланд, 50200
- Chiang Mai Univ. ACTG CRS
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Gauteng
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Johannesburg, Gauteng, Южная Африка, 2092
- Wits HIV CRS
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KwaZulu Natal
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Durban, KwaZulu Natal, Южная Африка, 4001
- Durban Adult HIV CRS
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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>
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: ZDV/3TC+EFV
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
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600 mg taken orally daily
Другие имена:
150 mg/300 mg taken orally twice daily
Другие имена:
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Экспериментальный: ddI+FTC+ATV
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
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400 mg taken orally daily
Другие имена:
400 mg taken orally daily
Другие имена:
200 mg taken orally daily
Другие имена:
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Экспериментальный: TDF/FTC+EFV
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
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600 mg taken orally daily
Другие имена:
200 mg/300 mg taken orally once daily
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Time to Treatment Failure (PI Comparison)
Временное ограничение: 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)
Временное ограничение: 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).
|
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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
|
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)
Временное ограничение: Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
|
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.
|
Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
|
|
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)
Временное ограничение: Throughout follow-up until study closed (May 31,2010)
|
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).
|
Throughout follow-up until study closed (May 31,2010)
|
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Time to Immunologic Failure (NRTI Comparison)
Временное ограничение: At or after Week 48 (including all follow-up through study closure - May 31,2010)
|
Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.
|
At or after Week 48 (including all follow-up through study closure - May 31,2010)
|
|
Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)
Временное ограничение: weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)
|
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).
|
weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)
|
|
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)
Временное ограничение: At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)
|
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.
|
At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)
|
|
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Временное ограничение: Week 48 (using follow-up through study closure on May 31,2010)
|
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.
|
Week 48 (using follow-up through study closure on May 31,2010)
|
|
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)
Временное ограничение: Week 96 (using follow-up through to study closure on May 31,2010)
|
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.
|
Week 96 (using follow-up through to study closure on May 31,2010)
|
|
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Временное ограничение: Week 48 using follow-up through study closure on May 31,2010
|
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.
|
Week 48 using follow-up through study closure on May 31,2010
|
|
Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)
Временное ограничение: Week 96 using follow-up through study closure on May 31,2010
|
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.
|
Week 96 using follow-up through study closure on May 31,2010
|
|
Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)
Временное ограничение: Throughout study follow-up until study closure (May 31, 2010)
|
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.
|
Throughout study follow-up until study closure (May 31, 2010)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Учебный стул: Thomas B. Campbell, MD, University of Colorado, Denver
- Учебный стул: Timothy Flanigan, MD, The Miriam Hospital
- Учебный стул: James Hakim, MscClinEpi, FRCP, Department of Medicine, University of Zimbabwe
- Учебный стул: Nagalingeswaran Kumarasamy, MD, Centre for AIDS Research and Education
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 мая 2005 г.
Первичное завершение (Действительный)
1 мая 2010 г.
Завершение исследования (Действительный)
1 мая 2010 г.
Даты регистрации исследования
Первый отправленный
7 июня 2004 г.
Впервые представлено, что соответствует критериям контроля качества
7 июня 2004 г.
Первый опубликованный (Оценивать)
8 июня 2004 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
10 октября 2018 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
11 сентября 2018 г.
Последняя проверка
1 сентября 2018 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- РНК-вирусные инфекции
- Вирусные заболевания
- Инфекции
- Инфекции, передающиеся через кровь
- Передающиеся заболевания
- Заболевания, передающиеся половым путем, вирусные
- Заболевания, передающиеся половым путем
- Лентивирусные инфекции
- Ретровирусные инфекции
- Синдромы иммунологического дефицита
- Заболевания иммунной системы
- ВИЧ-инфекции
- Молекулярные механизмы фармакологического действия
- Противоинфекционные агенты
- Противовирусные агенты
- Ингибиторы обратной транскриптазы
- Ингибиторы синтеза нуклеиновых кислот
- Ингибиторы ферментов
- Агенты против ВИЧ
- Антиретровирусные агенты
- Антиметаболиты
- Ингибиторы протеазы
- Ингибиторы фермента цитохрома Р-450
- Индукторы фермента цитохрома Р-450
- Индукторы цитохрома P-450 CYP3A
- Ингибиторы протеазы ВИЧ
- Ингибиторы вирусной протеазы
- Индукторы цитохрома P-450 CYP2B6
- Ингибиторы цитохрома P-450 CYP2C9
- Ингибиторы цитохрома P-450 CYP2C19
- Тенофовир
- Эмтрицитабин
- Ламивудин
- Зидовудин
- Комбинация эмтрицитабина и тенофовира дизопроксила фумарата
- Диданозин
- Атазанавира сульфат
- Эфавиренц
- Комбинация ламивудина и зидовудина
Другие идентификационные номера исследования
- ACTG A5175
- 1U01AI068636 (Грант/контракт NIH США)
- 5K24AI051966-03 (Грант/контракт NIH США)
- PEARLS
- A5185s
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .