Overview of Nevirapine Research Projects
What is Nevirapine? Nevirapine is an inexpensive, easy-to-use drug that can help reduce the chances that HIV is passed from mother-to-infant during labor and delivery and breastfeeding. Nevirapine research projects have been running in Chitungwiza for almost 2 years.
Overall Objective and Goal: The goal of these projects is to identify a safe and effective regimen of Nevirapine that can be given to HIV-exposed infants (those with HIV+ mothers) so that infants can simultaneously breastfeed and also be protected against HIV virus in the mother’s breastmilk.
HIVNET 023: Phase I/II
Location: Seke North Clinic, Chitungwiza
Duration: March 2000 - August 2001
Adminstered by: ZAPP
Participants: 32 mother-infant pairs
Description: All mothers were given a single dose
of Nevirapine at the onset of labor to reduce the chances of HIV transmission,
and all infants were given a single dose of Nevirapine within 72 hours
of birth. In addition, infants were randomized to receive one of three
different Nevirapine dosing regimens (once a week, twice a week or a
daily dose) for the first six months of life. Mothers were counseled
and encouraged to maintain exclusive breastfeeding and wean at or before
6 months.
Results: Nevirapine was safe and well tolerated in the infants. Although
the sample was too small to generalize broadly, only 9% of the infants
were HIV-positive at 6 months, demonstrating a dramatic improvement
in reduction of transmission.
HPTN 046: Phase III
Location: Seke North, St. Mary’s, Seke South
and Zengeza Clinics in Chitungwiza and Harare Hospital
Duration: Estimated Start Date of March 2002, for 3-5 years
Administered by: UZ-UCSF Collaborative Research Programme
Participants: 450-500 mother-infant pairs
Description: All mothers are given a single dose of Nevirapine at the onset of labor to reduce the chances of HIV transmission, and all infants are given a single dose of Nevirapine within 72 hours of birth. In addition, infants will be randomized to receive either a daily dose of Nevirapine or a daily dose of a Nevirapine placebo for the first six months of life.
Results: To be determined
The HPTN 046 Study is being administered by the UZ-UCSF Collaborative Programme in Women’s Health, 15 Phillips Avenue, Belgravia, Harare, in collaboration with the University of Zimbabwe, Department of Community Medicine and Stanford University, Department of Pediatrics (USA).
For more information, please contact Jennifer Wells or Liz Montgomery at 091-268-522 or 04-704-890
You can also visit this site for further information
on the Zimbabwe HIV Prevention TrialsNetwork (PTN)
at http://www.uz-ucsf.co.zw