Nevirapine Study for the Prevention of Maternal-Infant HIV Transmission in Uganda

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The increase in pediatric HIV infection has a substantial impact on childhood mortality in the developing world. A number of recent studies suggest that as many as half or more of mother-to-child HIV transmissions in developing countries occur in late pregnancy or during labor and delivery. Interventions targeted during the perinatal period have shown to be effective and to have a significant impact in reducing transmission. The purpose of this study is to investigate the effectiveness of nevirapine (NVP) plus immunoprophylaxis or extended NVP dosing regimens in HIV-infected pregnant women and their infants during the perinatal period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Nevirapine; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Pregnant between 32-36 weeks estimated gestation

• HIV Infected

• Intent to breastfeed infant

• Certain laboratory criteria. More information on this criterion can be found in the protocol.

Exclusion Criteria:

• Sensitivity to immune globulin preparations or any benzodiazepine

• Clinically significant disease, as determined by the investigator, that would compromise the ability of the participant to complete the study requirements

• Currently receiving antiretroviral therapy (other than the intrapartum NVP or other peripartum regimens)

• Participation in any HIV vaccine trials

• History of cytotoxic chemotherapy within one month of study entry

• Uncontrolled hypertension

• Chronic alcohol or illicit drug use

• History of non-compliance with visits or medication

• Women who become pregnant again during study follow-up will not be eligible for re-enrollment in the trial