At a glance
ClinicalIndex Comparison Record- ✓HIV-infected
- ✓Pregnant with a viable fetus between 28-38 weeks gestation
- ✓CD4 count >250 cells/mm3 within 30 days prior to study entry
- ✓Able to receive oral antiretroviral therapy during labor
- ✕Known allergy or hypersensitivity to didanosine, lopinavir, nevirapine, ritonavir, or zidovudine
- ✕Any antiretroviral therapy other than zidovudine during a previous pregnancy or current pregnancy
- ✕Planning to receive additional antiretroviral therapy during the first 8 weeks postpartum
- ✕Planning to breastfeed
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of the Pharmacokinetics of Nevirapine and the Incidence of Nevirapine Resistance Mutations in HIV-Infected Women Receiving a Single Intrapartum Dose of Nevirapine With the Concomitant Administration of Zidovudine/Didanosine or Zidovudine/Didanosine/Lopinavir/Ritonavir
In Brief
A Phase 2 clinical trial evaluating Didanosine, enteric-coated, Lopinavir/ritonavir, and 2 other interventions for HIV Infections. Completed, enrolled 175 participants across 7 sites.
Detailed Summary
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and lopinavir/ritonavir (LPV/r) will also be studied. Study hypothesis: NVP resistance following single-dose NVP can be prevented with the concomitant administration of additional antiretroviral therapy (ART).
Study Details
Timeline
Interventions
once daily
twice daily
single-dose at the onset of labor
twice daily