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Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings (PEARLS)

11. září 2018 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

1571

Fáze

  • Fáze 4

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Brazílie
    • RS
      • Porto Alegre, RS, Brazílie, 91350-200
        • Hospital Nossa Senhora da Conceicao
    • Rio De Janeiro
      • Manguinhos, Rio De Janeiro, Brazílie
        • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
  • Haiti
    • Port-au-Prince
      • Bicentenaire, Port-au-Prince, Haiti, HT-6110
        • Les Centres GHESKIO CRS
  • Indie
      • Pune, Indie, 411026
        • Dr. Kotnis Dispensary
    • Chennai
      • Rajiv Gandhi Salai Taramani, Chennai, Indie, 600113
        • YRG CARE Medical Ctr., VHS Chennai CRS
    • Maharashtra
      • Pune, Maharashtra, Indie
        • NARI Pune CRS
    • Pune
      • Maharashtra State, Pune, Indie
        • NARI Clinic at NIV CRS
  • Jižní Afrika
    • Gauteng
      • Johannesburg, Gauteng, Jižní Afrika, 2092
        • Wits HIV CRS
    • KwaZulu Natal
      • Durban, KwaZulu Natal, Jižní Afrika, 4001
        • Durban Adult HIV CRS
  • Malawi
    • Blantyre
      • P.O. Box 1131, Blantyre, Malawi
        • College of Med. JHU CRS
    • Lilongwe
      • Mzimba Road, Lilongwe, Malawi
        • University of North Carolina Lilongwe CRS
  • Peru
    • Lima
      • Barranco, Lima, Peru
        • Asociacion Civil Impacta Salud y Educacion - Miraf CRS
      • San Miguel, Lima, Peru
        • San Miguel CRS
  • Spojené státy
    • California
      • Los Angeles, California, Spojené státy, 90033-1079
        • University of Southern California
      • Los Angeles, California, Spojené státy, 90095-1793
        • UCLA CARE Center CRS
      • Torrance, California, Spojené státy, 90502-2052
        • Harbor General/UCLA
    • Colorado
      • Denver, Colorado, Spojené státy
        • Univ. of Colorado Health Sciences Center, Denver
    • Hawaii
      • Honolulu, Hawaii, Spojené státy, 96816-2396
        • Univ. of Hawaii at Manoa, Leahi Hosp.
    • Illinois
      • Chicago, Illinois, Spojené státy, 60611-3015
        • Northwestern University
      • Chicago, Illinois, Spojené státy, 60612
        • Cook County Hospital Core Center
      • Chicago, Illinois, Spojené státy, 60612-3806
        • Rush-Presbyterian/St. Lukes (Chicago)
    • Minnesota
      • Minneapolis, Minnesota, Spojené státy, 55455-0392
        • University of Minnesota
    • Missouri
      • Saint Louis, Missouri, Spojené státy, 63108-2138
        • Washington University (St. Louis)
    • New York
      • HVTN 722 West 168th Street MSPH Bldg., New York, Spojené státy, 10032
        • HIV Prevention & Treatment CRS
      • New York, New York, Spojené státy, 10003
        • Beth Israel Medical Center
      • New York, New York, Spojené státy, 10016
        • NY Univ. HIV/AIDS CRS
      • New York, New York, Spojené státy, 10011
        • Cornell CRS
      • Rochester, New York, Spojené státy, 14642-0001
        • Univ. of Rochester ACTG CRS
      • Rochester, New York, Spojené státy, 14642-0001
        • Community Health Network, Inc.
    • North Carolina
      • Chapel Hill, North Carolina, Spojené státy, 27514
        • University of North Carolina
      • Chapel Hill, North Carolina, Spojené státy, 27514
        • Wake County Health and Human Services Clinical Research Site
      • Durham, North Carolina, Spojené státy, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45267-0405
        • University of Cincinnati
      • Columbus, Ohio, Spojené státy, 43210
        • The Ohio State Univ. AIDS CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, Spojené státy, 19104
        • Hosp. of the Univ. of Pennsylvania CRS
    • Rhode Island
      • Providence, Rhode Island, Spojené státy, 02906
        • The Miriam Hosp. ACTG CRS
      • Providence, Rhode Island, Spojené státy, 02906
        • Stanley Street Treatment and Resource
    • Tennessee
      • Nashville, Tennessee, Spojené státy, 37204
        • Vanderbilt Therapeutics CRS
    • Texas
      • Dallas, Texas, Spojené státy
        • University of Texas, Southwestern Medical Center
      • Galveston, Texas, Spojené státy, 77555-0435
        • University of Texas, Galveston
  • Thajsko
    • Chiang Mai
      • P.O. Box 80, Chiang Mai, Thajsko, 50200
        • Chiang Mai Univ. ACTG CRS
  • Zimbabwe
    • Harare
      • AIDS Research Unit P.O. Box A178, Harare, Zimbabwe
        • UZ-Parirenyatwa CRS

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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>

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: ZDV/3TC+EFV
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
Lék: Efavirenz
600 mg taken orally daily
Ostatní jména:
  • EFV
Lék: Lamivudine/Zidovudine
150 mg/300 mg taken orally twice daily
Ostatní jména:
  • 3TC/ZDV
Experimentální: ddI+FTC+ATV
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
Lék: Atazanavir
400 mg taken orally daily
Ostatní jména:
  • ATV
Lék: Didanosine (enteric-coated)
400 mg taken orally daily
Ostatní jména:
  • ddl
Lék: Emtricitabine
200 mg taken orally daily
Ostatní jména:
  • FTC
Experimentální: TDF/FTC+EFV
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Lék: Efavirenz
600 mg taken orally daily
Ostatní jména:
  • EFV
Lék: Emtricitabine/Tenofovir disoproxil fumarate
200 mg/300 mg taken orally once daily
Ostatní jména:
  • FTC/TDF

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to Treatment Failure (PI Comparison)
Časové okno: 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).
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 until ddI+FTC+ATV arm closed (May 22, 2008).
Time to Treatment Failure (NRTI Comparison)
Časové okno: 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).
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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
Časové okno: Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)
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 ddI+FTC+ATV arm closed (May 22,2008)
Time to Immunologic Failure (PI Comparison)
Časové okno: At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)
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 only follow-up until ddI+FTV+ATV arm closed - May 22,2008)
Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)
Časové okno: weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
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 follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)
Časové okno: Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)
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 ddI+FTC+ATV arm closed (May 22, 2008)
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)
Časové okno: At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
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 only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)
Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)
Časové okno: 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.
Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)
Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)
Časové okno: 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)
Časové okno: 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)
Time to Immunologic Failure (NRTI Comparison)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

AIDS Clinical Trials Group

Spolupracovníci

National Institute of Allergy and Infectious Diseases (NIAID)

Vyšetřovatelé

  • Studijní židle: Thomas B. Campbell, MD, University of Colorado, Denver
  • Studijní židle: Timothy Flanigan, MD, The Miriam Hospital
  • Studijní židle: James Hakim, MscClinEpi, FRCP, Department of Medicine, University of Zimbabwe
  • Studijní židle: Nagalingeswaran Kumarasamy, MD, Centre for AIDS Research and Education

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. května 2005

Primární dokončení (Aktuální)

1. května 2010

Dokončení studie (Aktuální)

1. května 2010

Termíny zápisu do studia

První předloženo

7. června 2004

První předloženo, které splnilo kritéria kontroly kvality

7. června 2004

První zveřejněno (Odhad)

8. června 2004

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

10. října 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. září 2018

Naposledy ověřeno

1. září 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ACTG A5175
  • 1U01AI068636 (Grant/smlouva NIH USA)
  • 5K24AI051966-03 (Grant/smlouva NIH USA)
  • PEARLS
  • A5185s

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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