Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00006075 |
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 II |
Study Type: | Interventional |
Study Design: | Prevention, Dose Comparison |
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 |
Estimated Enrollment: | 150 |
Study Completion Date: | August 2007 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Mothers may be eligible for this study if they:
Exclusion Criteria
Mothers will not be eligible if they:
Study ID Numbers: | HIVNET 025 |
Study First Received: | July 27, 2000 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00006075 History of Changes |
Health Authority: | United States: Federal Government |
Pregnancy Complications, Infectious Dose-Response Relationship, Drug Polymerase Chain Reaction Disease Transmission, Vertical Labor |
Disinfectants Vagina Chlorhexidine Irrigation |
Sexually Transmitted Diseases, Viral Pregnancy Complications Chlorhexidine Pregnancy Complications, Infectious Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases |
Anti-Infective Agents, Local Disinfectants HIV Infections Chlorhexidine gluconate Sexually Transmitted Diseases Retroviridae Infections |
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Chlorhexidine Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Pharmacologic Actions Immunologic Deficiency Syndromes |
Virus Diseases Anti-Infective Agents, Local Disinfectants HIV Infections Chlorhexidine gluconate Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Dermatologic Agents Retroviridae Infections |