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A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies Clinical research trials and A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies. A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies clinical trial. Participants typically obtain the most effective healthcare available for their A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies  A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies
A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Prevention, Dose Comparison
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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).
Total Enrollment: 150
Location and Contact Information:
Overall Study Official:
CraigWilson, Study Chair,
Ann Koonce
Research Triangle Park, North Carolina, 27709
United States
Additional Information:
Study ID Numbers: HIVNET 025;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006075
Other Hiv Infections Studies:
1. The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients
2. ALVAC-HIV vCP1452 Alone and Combined with MN rgp120
3. Dexamethasone in Cryptococcal Meningitis
4. A Study of an Adherence Plan to Help HIV-Positive Patients Take Their First Anti-HIV Medications Correctly
5. Metformin and Rosiglitazone, Alone or in Combination, in HIV-Infected Patients with Insulin and Fat Abnormalities
Related Studies:
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A Study of Chlorhexidine in the Prevention of HIV-1 Transmission from Mothers to Their Babies
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