At a glance
ClinicalIndex Comparison Record- ✓HIV infection confirmed
- ✓CD4 count <200 cells/mm³ within 90 days prior to entry
- ✓Plasma HIV-1 RNA documented within 45 days prior to entry
- ✓Karnofsky performance score ≥70 within 45 days of entry
- ✕Prior antiretroviral use except nevirapine for MTCT prophylaxis (Trial 1) or ≤10 weeks of zidovudine alone completed ≥6 months prior
- ✕Systemic cancer chemotherapy, systemic investigational agents, immunomodulators, or rifampin within 30 days of entry
- ✕Pregnancy or breastfeeding
- ✕TB treatment within 30 days prior to entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Optimal Combination Therapy After Nevirapine Exposure
In Brief
A Phase 3 clinical trial evaluating Emtricitabine, Emtricitabine/Tenofovir disoproxil fumarate, and 3 other interventions for HIV Infections. Completed, enrolled 745 participants across 11 sites in 7 countries.
Detailed Summary
Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly included in anti-HIV drug regimens. However, HIV infected women who have previously taken the single dose NNRTI nevirapine (SD NVP) for the prevention of mother-to-child transmission (MTCT) of HIV may not respond as well to NNRTIs as women who have never taken NVP. Another class of anti-HIV drugs, protease inhibitors (PIs), may be more effective for women who have previously taken NNRTIs. This study will compare the effectiveness of NNRTI- and PI-based regimens in women who have taken NVP for prevention of MTCT of HIV. This study will also compare regimens including an NNRTI with regimens including a PI in women who have never taken NVP.
Study Details
Timeline
Interventions
200 mg taken orally
200/300 mg taken orally
400/100 mg taken orally
200 mg taken orally
300 mg taken orally