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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 27, 2000 | ||||||||
| Last Updated Date | September 26, 2008 | ||||||||
| Start Date ICMJE | |||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00006075 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Study of Chlorhexidine in the Prevention of HIV-1 Transmission From Mothers to Their Babies | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Dose Comparison | ||||||||
| Condition ICMJE | HIV Infections | ||||||||
| Intervention ICMJE | Drug: Chlorhexidine gluconate | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 150 | ||||||||
| Completion Date | August 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria Mothers may be eligible for this study if they:
Exclusion Criteria Mothers will not be eligible if they:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00006075 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | HIVNET 025 | ||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Verification Date | June 2004 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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