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:
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Formic acid
Emtricitabine
Tenofovir
Efavirenz
Tenofovir Disoproxil Fumarate
Truvada
U.S. FDA Resources
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
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 June 18, 2013