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

11 september 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

1571

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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>

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: ZDV/3TC+EFV
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
Läkemedel: Efavirenz
600 mg taken orally daily
Andra namn:
  • EFV
Läkemedel: Lamivudine/Zidovudine
150 mg/300 mg taken orally twice daily
Andra namn:
  • 3TC/ZDV
Experimentell: ddI+FTC+ATV
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
Läkemedel: Atazanavir
400 mg taken orally daily
Andra namn:
  • ATV
Läkemedel: Didanosine (enteric-coated)
400 mg taken orally daily
Andra namn:
  • ddI
Läkemedel: Emtricitabine
200 mg taken orally daily
Andra namn:
  • FTC
Experimentell: TDF/FTC+EFV
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Läkemedel: Efavirenz
600 mg taken orally daily
Andra namn:
  • EFV
Läkemedel: Emtricitabine/Tenofovir disoproxil fumarate
200 mg/300 mg taken orally once daily
Andra namn:
  • FTC/TDF

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Treatment Failure (PI Comparison)
Tidsram: 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)
Tidsram: 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).

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

AIDS Clinical Trials Group

Samarbetspartners

National Institute of Allergy and Infectious Diseases (NIAID)

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2005

Primärt slutförande (Faktisk)

1 maj 2010

Avslutad studie (Faktisk)

1 maj 2010

Studieregistreringsdatum

Först inskickad

7 juni 2004

Först inskickad som uppfyllde QC-kriterierna

7 juni 2004

Första postat (Uppskatta)

8 juni 2004

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 oktober 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 september 2018

Senast verifierad

1 september 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ACTG A5175
  • 1U01AI068636 (U.S.S. NIH-anslag/kontrakt)
  • 5K24AI051966-03 (U.S.S. NIH-anslag/kontrakt)
  • PEARLS
  • A5185s

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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