Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Didanosine; Lopinavir; Nevirapine; Ritonavir; Zidovudine

Criteria

Inclusion Criteria for Mothers:

• HIV infected

• Pregnant with a viable fetus

• Between 28 and 38 weeks of pregnancy

• CD4 count greater than 250 cells/mm3 within 30 days prior to study entry

• Able to receive oral ART during labor

• Willing to use acceptable forms of contraception while on study treatment

• Able to provide written informed consent

Exclusion Criteria for Mothers:

• Known allergy or hypersensitivity to ddI, LPV, NVP, ritonavir (RTV), or ZDV

• Any ART other than ZDV during a previous pregnancy or the current pregnancy

• Certain medications

• Planning to receive additional ART during the first 8 weeks postpartum

• Planning to breastfeed

• Unlikely to comply with postpartum study requirements, in the opinion of the investigator

• Certain abnormal laboratory values within 30 days prior to study entry