Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed

Phase 3

Conditions

HIV Infections

Treatments

Drug: Nevirapine

Drug: Nevirapine placebo

Study type

Interventional

Funder types

NIH

Identifiers

NCT00074399

5R01AI038576-05

NIGAT Project

Details and patient eligibility

About

HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission.

Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding.

Full description

The use of antiretroviral therapy during late pregnancy, intrapartum, and immediately postpartum prevents a high proportion of vertical transmission. Potential means of decreasing HIV transmission through breastfeeding, along with the risks and benefits of early weaning, need to be further evaluated. The potential impact of early weaning interventions on the breastfeeding habits of the HIV uninfected population needs to be considered as well. This study seeks to identify a way to make breastfeeding safe for HIV infected women who choose to breastfeed.

A single dose of NVP given to infants of HIV infected mothers appears to provide some protection against vertical transmission. NVP's long half-life allows simple dosing, making it more feasible and affordable to implement in a developing country. This study will determine whether extending the NVP dosing to six weeks will significantly decrease transmission during the first several months of breastfeeding.

Enrollment

775 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

HIV infection, documented on two separate specimens
Estimated gestational age at enrollment of 32 weeks or more as indicated by last menstrual cycle and fundal height
Permanent residency in Addis Ababa
Plan to deliver at a hospital affliated with the study (Tikur Anbessa Hospital, Gandhi hospital, or St. Paul's Hospital)
Hemoglobin >= 7.5 gm/dl within 4 weeks prior to study entry
Serum glutamic pyruvic transaminase (SGPT) < 5 times upper limit of normal within 4 weeks prior to study entry
Serum creatinine < 1.5 mg/dl within 4 weeks prior to study entry
Consent form signed by the mother and, when possible, by the father, prior to the onset of labor