HIV Infections Clinical Trial
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
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.
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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.
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