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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00006075
First received: July 27, 2000
Last updated: September 26, 2008
Last verified: June 2004
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Chlorhexidine gluconate
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Prevention
Official Title: Phase IIA Study of Tolerance and Safety of Differing Concentrations of Chlorhexidine, for Peripartum Vaginal and Infant Washes, to Prevent Mother to Infant HIV-1 Transmission

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 150
Study Completion Date: August 2007
Detailed Description:

The principal hypothesis of this protocol is that, in the context of routine oral/nasal suctioning of infants, a higher concentration of chlorhexidine for peripartum vaginal and postpartum newborn cleansing results in reduction in maternal child transmission (MCT) of HIV. The in vitro data suggest that a higher concentration of chlorhexidine in the primary wash solution is much more likely to have a virucidal effect perinatally and thus reduce MCT.

Perinatal intervention consists of the following: 1) cervicovaginal wash of the entire birth canal with a chlorhexidine solution at the time of each vaginal examination of a mother in labor; 2) immediate suctioning of the nasal and oral passages of the infant at the time the head emerges (fluids to be tested for viral load at future date); and 3) thorough washing of the baby with a chlorhexidine solution immediately after delivery. Blood samples are collected from some infants for measurement of chlorhexidine levels approximately 2 hours post-washing. During the 24 to 48 hours following delivery, infants are examined and mothers are queried using standardized questionnaires for subjective complaints related to the chlorhexidine washes. Speculum-aided vaginal exams are done for any persistent (greater than 24 hours) or severe complaints.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006075

Locations
United States, North Carolina
Ann Koonce
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Investigators
Study Chair: Craig Wilson
Study Chair: Sten Vermund
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006075     History of Changes
Other Study ID Numbers: HIVNET 025
Study First Received: July 27, 2000
Last Updated: September 26, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Pregnancy Complications, Infectious
Dose-Response Relationship, Drug
Polymerase Chain Reaction
Disease Transmission, Vertical
Labor
Disinfectants
Vagina
Chlorhexidine
Irrigation

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014