Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Nevirapine (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Official title: Nevirapine (NVP) Use to Prevent Maternal-Infant HIV Transmission: A Randomized Clinical Trial of Two Doses of NVP Compared to Six Weeks of NVP for the Prevention of Maternal-Infant HIV Transmission in the Breastfeeding Infant
Study design: Prevention, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Infant HIV infection status at 6 and 12 months of age
Infant mortality rate
infant morbidity rate
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.
Minimum age: N/A.
Maximum age: N/A.
- 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
Locations and Contacts
Tikur Anbessa Hospital, Addis Ababa, Ethiopia
Click here for more information on nevirapine
Starting date: February 2001
Last updated: September 17, 2007