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:
Collaborator:
Information provided by:
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00442962
First received: March 2, 2007
Last updated: December 22, 2011
Last verified: December 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml


Secondary Outcome Measures:
  • Time to First Safety Event [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml

  • Percentage of Participants With Late Virologic Response [ Time Frame: At Week 48 ] [ Designated as safety issue: No ]
    Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml

  • Time to Initial Virologic Response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Early Changes in CD4 Count From Baseline [ Time Frame: At weeks 0(baseline), 4, 8, 16, 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml

  • Time to First Dose Modification [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
    Time from starting study treatment to first dose/drug modification.

  • Late Change in CD4 Count From Baseline [ Time Frame: At week 48 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   16 Years and older
Genders 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 1.0)
  • 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 2.0, 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
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
Barranco CRS
Lima, 18, Peru
San Miguel CRS
San Miguel, Lima, Peru
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
Study Chair: Mary A. Vogler, MD Division of Infectious Diseases, Weill College of Medicine of Cornell University
  More Information

Additional Information:
Publications:
Responsible Party: Daniel R. Kuritzkes, M.D., Social & Scientific Systems, Inc.
ClinicalTrials.gov Identifier: NCT00442962     History of Changes
Other Study ID Numbers: ACTG A5227, 1U01AI068636
Study First Received: March 2, 2007
Results First Received: July 13, 2011
Last Updated: December 22, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Tenofovir
Tenofovir disoproxil
Efavirenz
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 24, 2014