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

NCT00006075 | Completed Phase 2

• 1 other identifier: HIVNET 025
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Keywords

Pregnancy Complications, Infectious; Dose-Response Relationship, Drug; Polymerase Chain Reaction; Disease Transmission, Vertical; Labor; Disinfectants; Vagina; Chlorhexidine; Irrigation

Interventions

Chlorhexidine gluconate DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Ann Koonce

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (1)

• Wilson CM, Gray G, Read JS, Mwatha A, Lala S, Johnson S, Violari A, Sibiya PM, Fleming TR, Koonce A, Vermund SH, McIntyre J. Tolerance and safety of different concentrations of chlorhexidine for peripartum vaginal and infant washes: HIVNET 025. J Acquir Immune Defic Syndr. 2004 Feb 1;35(2):138-43. doi: 10.1097/00126334-200402010-00006.

  PMID: 14722445 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Craig Wilson

  STUDY CHAIR

• Sten Vermund

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 27, 2000
• First Posted: August 31, 2001
• Study Completion: August 1, 2007
• Last Updated: September 30, 2008

Record last verified: 2004-06

Locations

US (1)