At a glance
ClinicalIndex Comparison Record- ✓HIV-1 infected
- ✓CD4 count ≥250 cells/mm3 within 30 days of study entry
- ✓Pregnant with viable fetus at 28-38 weeks gestation
- ✓Willing to give birth in a hospital or clinic
- ✕Any prior ART (except ZDV monotherapy prior to labor under site investigator supervision)
- ✕Known allergy or sensitivity to study drugs or formulations
- ✕Current drug or alcohol abuse that may interfere with study
- ✕Serious illness requiring systemic treatment or hospitalization (unless completed therapy or stable for ≥14 days prior)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Maintaining Options for Mothers Study (MOMS): A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of Nevirapine Resistant HIV-1 Following a Single Intrapartum Dose of Nevirapine
In Brief
A Phase 2 clinical trial evaluating Emtricitabine/Tenofovir Disoproxil Fumarate, Lamivudine/Zidovudine, and 2 other interventions for HIV Infections. Completed, enrolled 484 participants across 8 sites in 6 countries.
Detailed Summary
HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to prevent mother-to-child transmission (MTCT) of HIV. However, SD NVP may cause NVP resistance in the mother, potentially ruling out some treatment options in the future. The purpose of this study is to determine which of three anti-HIV drug regimens most effectively reduces the development of maternal NVP resistance in HIV infected pregnant women. The effectiveness of short-term (7 day therapy) versus long-term (21-day therapy) regimens will also be compared. The study hypotheses are: 1) intrapartum SD NVP with a 21-day course of antiretroviral therapy (ART) results in less frequent selection of NVP-resistant HIV-1 variants than intrapartum SD NVP with a 7-day course of ART, and 2) a 7- or 21-day course of lamivudine/zidovudine (3TC/ZDV), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), or lopinavir/ritonavir (LPV/r) following SD NVP will not select nucleoside reverse transcriptase inhibitor (NRTI)- or protease inhibitor (PI)- resistant HIV-1 variants.
Study Details
Timeline
Interventions
200mg/300mg as one tablet taken orally once daily
150mg/300mg as one tablet taken orally twice daily
133.3mg/33.3mg as three capsules taken orally twice daily
one 200 mg tablet taken orally