HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV (Nearly Naive)
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.
Drug: Emtricitabine/Tenofovir disoproxil fumarate
|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|
- 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
- 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.
|Study Start Date:||May 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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
600-mg tablet taken orally daily
Other Name: EFVDrug: Emtricitabine/Tenofovir disoproxil fumarate
200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily
Other Name: Truvada
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.
> 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.
> Enrollment in this study will last until 47 participants have joined or until December 31, 2009, whichever comes later.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00442962
|United States, California|
|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|
|Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz|
|Rio de Janeiro, Brazil, 21045|
|San Miguel CRS|
|San Miguel, Lima, Peru|
|Lima, Peru, 18|
|Study Chair:||Mary A. Vogler, MD||Division of Infectious Diseases, Weill College of Medicine of Cornell University|