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Clinical Trials

MainTitle

HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV (Nearly Naive)

This study has been completed
Sponsor
AIDS Clinical Trials Group

Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party)
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier
NCT00442962

First received: March 2, 2007
Last updated: June 1, 2015
Last Verified: June 2015
History of Changes
Purpose

Purpose

The purpose of this study is to determine if pregnancy-limited, short-term combination HIV treatment regimens -- which were used solely for the prevention of mother to child transmission of HIV and discontinued postpartum -- decreases the effectiveness of a standard initial regimen of anti-HIV drugs when subsequent treatment is needed.

Condition Intervention Phase
HIV Infections

Drug : Efavirenz
Drug : Emtricitabine/Tenofovir disoproxil fumarate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Prior Short Course Combination Antiretroviral Therapy Administered for the Prevention of Mother-to-Child Transmission (pMTCT) of HIV-1 on Subsequent Treatment Efficacy in Treatment-"Nearly Naive" Participants

Further study details as provided by AIDS Clinical Trials Group:

Primary Outcome Measures

  • Percentage of Participants With Early Virologic Response [ Time Frame: At Week 24 ]
    Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml
Secondary Outcome Measures:
  • Time to First Safety Event [ Time Frame: Throughout study ]
    Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.
  • Percentage of Participants With Early Virologic Suppression [ Time Frame: At Weeks 24 ]
    Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml
  • Percentage of Participants With Late Virologic Response [ Time Frame: At Week 48 ]
    Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml
  • Time to Initial Virologic Response [ Time Frame: Throughout study ]
    Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.
  • Time to Initial Virological Failure [ Time Frame: Throughout study ]
    Virologic failure defined as two consecutive measurements of plasma HIV-1 RNA at least 400 copies/mL at or after the week 16 study visit. Time measured from enrollment.
  • Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm) [ Time Frame: Throughout study ]
  • Early Changes in CD4 Count From Baseline [ Time Frame: At weeks 0(baseline), 4, 8, 16, 24 ]
    Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline.
  • Percentage of Participants With Late Virologic Suppression [ Time Frame: At Week 48 ]
    Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml
  • Time to First Dose Modification [ Time Frame: Throughout study ]
    Time from starting study treatment to first dose/drug modification.
  • Late Change in CD4 Count From Baseline [ Time Frame: At week 48 ]
    Change in CD4+ lymphocyte counts between week 48 study visit and baseline.

Enrollment: 54
Study Start Date: May 2007
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: EFV + FTC/TDF
Participants will efavirenz (600mg in pill form, taken orally, once daily) and emtricitabine/tenofovir disoproxil fumarate (200/300mg in pill form, taken orally, once daily), for 48 weeks
Drug: Efavirenz

600-mg tablet taken orally daily

Other Name: EFV
Drug: Emtricitabine/Tenofovir disoproxil fumarate

200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily

Other Name: Truvada

Detailed Description:

Stopping and restarting highly active antiretroviral therapy (HAART) is not generally recommended because it has the potential to allow drug-resistant HIV to emerge. However, to prevent mother-to-child transmission (MTCT), HIV infected women who are pregnant are temporarily put on HAART, even if HIV treatment is not indicated at the time. It is unknown if such short-term therapy affects the viral response to HAART later, when permanent therapy is clinically indicated. The purpose of this study is to determine if HAART taken to prevent MTCT during pregnancy has an effect on the ability of a standard initial regimen of HAART to suppress HIV viral load.
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> Study follow-up will last for 48 weeks per participant. Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate. There will be 8 clinical visits in this study; visits will occur at baseline and at Weeks 2, 4, 8, 16, 24, 36, and 48. At each visit, a physical exam, blood and urine collection, and pregnancy tests will occur. At some visits, adherence, quality-of-life, and birth control interviews will be completed.
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> Enrollment in this study will last until 47 participants have joined or until December 31, 2009, whichever comes later.

Eligibility

Eligibility

Ages Eligible for Study: 16 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • HIV-1 infected
  • Viral load of 500 copies/mL or more
  • Prior HAART for more than 7 days, but less than 40 weeks during at least one previous pregnancy for prevention of MTCT of HIV
  • Clinical or laboratory indication to start HAART, in the opinion of the participant's physician
  • Certain laboratory values
  • Willingness to use acceptable forms of contraception
  • Parent or guardian willing to provide informed consent, if applicable

  • Exclusion Criteria:
  • Taking any antiretroviral medication within 24 weeks prior to study entry
  • Evidence of certain HIV-1 RT mutations within 90 days prior to study entry (version ~#o1~0)
    • Evidence of certain HIV-1 RT mutations identified by standard bulk viral population genotypic resistance tests at any time prior to study entry, if available (version ~#o1~0, 09/03/2009)
      • Treatment at any time, for any reason with nevirapine as a single agent OR addition of any part of the study regimen as a single agent to a failing regimen
      • Use of certain antihistamines, certain anti-infectives, cisapride, St John's wort, midazolam, triazolam, dihydroergotamine, ergonovine, ergotamine, or methylergonovine within 14 days prior to study entry
      • Use of HIV vaccine, chronic systemic corticosteroids, interleukins, interferons, other cytokines, or investigational therapy within 30 days prior to study entry
      • Acute or chronic therapy for certain serious medical illnesses within 14 days of study entry. Participants who have completed 7 days of therapy and are judged clinically stable are not excluded.
      • Cancer requiring systemic chemotherapy
      • Known allergy/sensitivity to the study drugs or their formulations
      • Current drug or alcohol use that, in the opinion of the investigator, would interfere with the study
      • Two consecutive HIV viral loads of more than 5,000 copies/mL 8 weeks or more following initiation of HAART during pregnancy and while still receiving HAART
      • Two consecutive viral loads of more than 400 copies/mL 24 weeks or more following initiation of HAART during pregnancy while still receiving HAART
      • Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness
      • Pregnancy or breastfeeding

      contacts and locations

      Contacts and Locations

      Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

      Please refer to this study by its ClinicalTrials.gov identifier: NCT00442962

      Locations

      United States, California
      Ucsd, Avrc
      San Diego, California, United States, 92103
      United States, Massachusetts
      Brigham and Women's Hospital, Division of Infectious Disease
      Boston, Massachusetts, United States, 02115
      United States, Missouri
      Washington University School of Medicine
      St. Louis, Missouri, United States, 63108
      United States, New York
      Bronx-Lebanon Hosp. Ctr. CRS
      Bronx, New York, United States, 10457
      Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea
      New York, New York, United States, 10011
      United States, North Carolina
      University of North Carolina
      Chapel Hill, North Carolina, United States, 27514
      Brazil
      Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz
      Rio de Janeiro, Brazil, 21045
      Peru
      San Miguel CRS
      San Miguel, Lima, Peru
      Barranco CRS
      Lima, Peru, 18

      Sponsors and Collaborators

      AIDS Clinical Trials Group
      National Institute of Allergy and Infectious Diseases (NIAID)

      Investigators

      Study Chair: Mary A. Vogler, MD Division of Infectious Diseases, Weill College of Medicine of Cornell University
      More Information

      More Information

      Additional Information:

      Click here for more information on this network of studies

      Responsible Party: AIDS Clinical Trials Group  
      ClinicalTrials.gov Identifier: NCT00442962   History of Changes  
      Other Study ID Numbers: ACTG A5227  
        1U01AI068636  
      Study First Received: March 2, 2007  
      Last Updated: June 1, 2015  

      Additional relevant MeSH terms:
      HIV Infections
      Tenofovir
      Emtricitabine
      Efavirenz
      Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

      ClinicalTrials.gov processed this data on October 18, 2017
      This information is provided by ClinicalTrials.gov.