A Study of Chlorhexidine in the Prevention of HIV-1 Transmission From Mothers to Their Babies

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find the best strength of chlorhexidine (a solution that kills germs), for washing the mother's vagina during labor and the newborn baby, that may reduce the chance of HIV being passed from an HIV-positive mother to the baby.

When used as a wash on the vagina during labor, and on a newborn shortly after birth, a higher dose of chlorhexidine is more likely to reduce the rate of HIV-1 transmission from mother to baby. Laboratory tests suggest that a higher dose of chlorhexidine will be more effective in killing HIV.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

Inclusion Criteria

Mothers may be eligible for this study if they:

• Receive HIV testing and counseling (both HIV-positive and HIV-negative women will be enrolled).

• Are at least 36 weeks pregnant.

• Are receiving routine prenatal care at the Chris Hani Baragwanath Hospital maternity unit in Soweto, South Africa.

Exclusion Criteria

Mothers will not be eligible if they:

• Have severe complications during the pregnancy, such as bleeding before birth.

• Have a C-section by choice.

• Have obvious genital sores at the time of labor.

• Have a baby that is positioned a certain way during delivery.

• Receive prostaglandin tablets, in the vagina, during labor.

• Have major medical conditions, such as TB or diabetes (except HIV, in HIV-positive women).