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

11 settembre 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1571

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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>

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ZDV/3TC+EFV
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
Droga: Efavirenz
600 mg taken orally daily
Altri nomi:
  • EFV
Droga: Lamivudine/Zidovudine
150 mg/300 mg taken orally twice daily
Altri nomi:
  • 3TC/ZDV
Sperimentale: ddI+FTC+ATV
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
Droga: Atazanavir
400 mg taken orally daily
Altri nomi:
  • Quad
Droga: Didanosine (enteric-coated)
400 mg taken orally daily
Altri nomi:
  • ddl
Droga: Emtricitabine
200 mg taken orally daily
Altri nomi:
  • FTC
Sperimentale: TDF/FTC+EFV
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Droga: Efavirenz
600 mg taken orally daily
Altri nomi:
  • EFV
Droga: Emtricitabine/Tenofovir disoproxil fumarate
200 mg/300 mg taken orally once daily
Altri nomi:
  • FTC/TDF

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Treatment Failure (PI Comparison)
Lasso di tempo: 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)
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AIDS Clinical Trials Group

Collaboratori

National Institute of Allergy and Infectious Diseases (NIAID)

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2005

Completamento primario (Effettivo)

1 maggio 2010

Completamento dello studio (Effettivo)

1 maggio 2010

Date di iscrizione allo studio

Primo inviato

7 giugno 2004

Primo inviato che soddisfa i criteri di controllo qualità

7 giugno 2004

Primo Inserito (Stima)

8 giugno 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 ottobre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 settembre 2018

Ultimo verificato

1 settembre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ACTG A5175
  • 1U01AI068636 (Sovvenzione/contratto NIH degli Stati Uniti)
  • 5K24AI051966-03 (Sovvenzione/contratto NIH degli Stati Uniti)
  • PEARLS
  • A5185s

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

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Sponsor / Collaboratori

Sedi

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