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

11 de septiembre de 2018 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

1571

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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>

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: ZDV/3TC+EFV
ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
Droga: Efavirenz
600 mg taken orally daily
Otros nombres:
  • EFV
Droga: Lamivudine/Zidovudine
150 mg/300 mg taken orally twice daily
Otros nombres:
  • 3TC/ZDV
Experimental: ddI+FTC+ATV
ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
Droga: Atazanavir
400 mg taken orally daily
Otros nombres:
  • Canal de televisión británico
Droga: Didanosine (enteric-coated)
400 mg taken orally daily
Otros nombres:
  • ddl
Droga: Emtricitabine
200 mg taken orally daily
Otros nombres:
  • FTC
Experimental: TDF/FTC+EFV
TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
Droga: Efavirenz
600 mg taken orally daily
Otros nombres:
  • EFV
Droga: Emtricitabine/Tenofovir disoproxil fumarate
200 mg/300 mg taken orally once daily
Otros nombres:
  • FTC/TDF

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Treatment Failure (PI Comparison)
Periodo de tiempo: 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)
Periodo de tiempo: 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).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AIDS Clinical Trials Group

Colaboradores

National Institute of Allergy and Infectious Diseases (NIAID)

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2005

Finalización primaria (Actual)

1 de mayo de 2010

Finalización del estudio (Actual)

1 de mayo de 2010

Fechas de registro del estudio

Enviado por primera vez

7 de junio de 2004

Primero enviado que cumplió con los criterios de control de calidad

7 de junio de 2004

Publicado por primera vez (Estimar)

8 de junio de 2004

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de octubre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

11 de septiembre de 2018

Última verificación

1 de septiembre de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ACTG A5175
  • 1U01AI068636 (Subvención/contrato del NIH de EE. UU.)
  • 5K24AI051966-03 (Subvención/contrato del NIH de EE. UU.)
  • PEARLS
  • A5185s

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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