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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
600-mg tablet taken orally daily
200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily
Ucsd, Avrc
San Diego, California, United States
Brigham and Women's Hospital, Division of Infectious Disease
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Percentage of Participants With Early Virologic Response
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml
Time frame: At Week 24
Time to First Safety Event
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.
Time frame: Throughout study
Percentage of Participants With Early Virologic Suppression
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml
Time frame: At Weeks 24
Percentage of Participants With Late Virologic Response
Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml
Time frame: At Week 48
Time to Initial Virologic Response
Time from enrollment to scheduled week of first plasma HIV-1 RNA viral load fewer than 400 copies/mL.
Time frame: Throughout study
Time to Initial Virological Failure
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 frame: Throughout study
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
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Weill Med. College of Cornell Univ., The Cornell CTU -Chelsea
New York, New York, United States
Bronx-Lebanon Hosp. Ctr. CRS
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz
Rio de Janeiro, Brazil
San Miguel CRS
San Miguel, Lima region, Peru
Barranco CRS
Lima, Peru
Changes in CD4+ lymphocyte counts between study visit weeks 4, 8 16 and 24 and baseline.
Time frame: At weeks 0(baseline), 4, 8, 16, 24
Percentage of Participants With Late Virologic Suppression
Plasma HIV-1 Viral Load Fewer Than 50 Copies/ml
Time frame: At Week 48
Time to First Dose Modification
Time from starting study treatment to first dose/drug modification.
Time frame: Throughout study
Late Change in CD4 Count From Baseline
Change in CD4+ lymphocyte counts between week 48 study visit and baseline.
Time frame: At week 48