Study Details

Protocol Status:
Study Purpose:

To determine the safety and minimum dosing schedule of nevirapine (NVP) given as prophylaxis which will maintain a trough concentration of greater than 0.1 microgram/ml among breastfeeding infants from birth to 6 months.

Study Design:

Phase I/II randomized open label clinical trial of 3 dosing frequencies of NVP

Study Population:

Mothers: HIV-1infected South African and Zimbabwean pregnant women who are planning to breastfeed will be consented for screening 28 to 34 weeks of gestation and for enrollment 30 to 38 weeks gestation. Infants: Breastfeeding infants born to HIV-1 infected enrolled mothers.

Study Size:

75 - Each dosing arm will enroll approximately 25 breastfed infants. Eighteen infants in each arm will contribute pre-dose trough, 4 hour post-dose, and post-dose trough NVP levels. The remaining infants will contribute data on safety and pre-dose trough NVP levels only.

Study Duration:

Mothers: from about 28 - 34 weeks gestation to 8 months postpartum
Infants: from birth to 8 months

Treatment Regimen:

Pregnant women who are 28 to 34 weeks gestation will be offered HIV testing to screen for the HIVNET 023 study. Women who test HIV-positive will be offered intrapartum/newborn NVP regimen (as in HIVNET 012) or, if eligible, enrollment in the 023 NVP breastfeeding study. Women and infants who do not enroll in the 023 NVP breastfeeding study, but who accept the intrapartum/newborn NVP regimen, will be enrolled for safety follow-up.

Pregnant HIV-positive women who are eligible and enroll in the 023 NVP breastfeeding study will take an oral dose of 200 mg NVP at the onset of labor. Newborn infants who do not initiate breastfeeding within 48 hours of birth will receive a single oral dose of 2 mg/kg NVP within 72 hours of birth. Infants who initiate breastfeeding will be randomized to one of the 3 study arms below and will receive their first dose of NVP between birth and 48 hours postpartum.

Primary Objectives:

To determine the dose and frequency of NVP that is safe and maintains levels above 0.1microgram/ml continuously from birth to 24 weeks life.

Secondary Objectives:

To determine the incidence of NVP resistance in those infants who become infected with HIV during the study
To monitor the rates of cessation of breastfeeding during the first 6 months
To monitor the rates of weaning when study drug is discontinued at 6 months
To monitor the loss to follow-up of infants
To determine the rates of compliance within each dosing arm

Key Study Personnel

Personnel list available upon request.

Study Sites List