NCT00442962

HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

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.\> \>\> \> \>\> 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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Efavirenz	600-mg tablet taken orally daily
DRUG	Emtricitabine/Tenofovir disoproxil fumarate	200-mg emtricitabine/300-mg tenofovir disoproxil fumarate tablet taken orally once daily

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2007-03-05
• Last updated: 2018-10-12
• Results posted: 2011-08-09

Locations

9 sites across 3 countries: United States, Brazil, Peru