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Home > "U" Clinical Trials Conditions > Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding  Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
For Condition: HIV Infections,HIV Seronegativity
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD),National Institute on Drug Abuse (NIDA),National Institute of Mental Health (NIMH)
Synopsis: The many benefits of breastfeeding are well documented. However, because of the risk of mother-to-child transmission (MTCT) of HIV from an HIV infected mother to her infant, there is considerable concern over the practice, especially in developing countries. The purpose of this study is to determine the safety and effectiveness of the anti-HIV drug nevirapine (NVP) in preventing MTCT of HIV in breastfeeding infants born to HIV infected women in South Africa, Tanzania, Uganda, and Zimbabwe.
Details: Breastfeeding provides general health, growth, and development benefits to an infant and significantly decreases the risk of certain acute and chronic diseases. Breastfeeding also decreases financial burden on the mother by decreasing the need for infant formula and health care for the infant. However, clinical evidence has shown that HIV can be readily transmitted through breast milk, although the risk of HIV MTCT over time while breastfeeding has been difficult to determine. Given the many advantages of breastfeeding and the significant obstacles to substituting formula for breast milk in developing countries, there is an urgent need to make breastfeeding by HIV infected women safe. This study will evaluate the safety and efficacy of an extended NVP regimen for prevention of MTCT of HIV through breastfeeding. Mother/infant pairs will be enrolled over a period of 18 to 24 months. During the third trimester of pregnancy, HIV infected participants will receive HIV counseling and the intrapartum/neonatal two-dose NVP prophylaxis regimen to prevent MTCT. Mothers will also be given infant feeding options counseling and information on administering the study drug to the infant. Eligible infants will be randomly assigned to one of two groups. The first group will receive NVP; the second group will receive placebo. Infants will receive the NVP or placebo for the first 6 months of life or until cessation of breastfeeding, whichever occurs earlier. Follow-up evaluations will be conducted at Weeks 2 and 6 and Months 3, 6, 12, and 18 for mothers, and at Weeks 2, 4, 6, and 8 and Months 3, 4, 5, 6, 9, 12, and 18 for infants. Study visits will include physical examinations, blood tests, and medical histories. Study participants will be followed for up to 3.5 years.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria for Mothers - 18 years of age or older - HIV infected - In third trimester of pregnancy, or at most 3 days post-delivery - If baby is not yet born, planning to deliver at a facility where the study is being conducted - Planning on breastfeeding Exclusion Criteria for Mothers - Complications with this pregnancy - Active serious infection other than HIV - Other serious illnesses Inclusion Criteria for Infants - Born to an HIV infected mother who is eligible for the study - Weighed at least 2000 grams (4.4 lbs) at birth - Blood sample obtained from the infant for HIV-1 DNA PCR, CBC with differential, and ALT - Infants in a multiple birth are eligible only if both/all infants are eligible for the study and assigned to the same study group Exclusion Criteria for Infants - Unable to breastfeed (e.g., mother died or is otherwise unable or unwilling to breastfeed) - Skin rash grade 2B (urticaria), grade 3 or above - Confirmed or suspected clinical hepatitis - Serious illness or condition that would interfere with compliance with study procedures
Total Enrollment: 1576
Location and Contact Information:
Overall Study Official:
HoosenCoovadia, Study Chair, Centre of HIV Networking (HIVAN), Nelson Mandela School of Medicine, University of Natal
Seke North
Harare, ,
Zimbabwe
Jennifer Wells 01-263-4-704-890
Prince Mshiyeni Hospital
Durban, ,
South Africa
Mulago Hospital
Kampala, ,
Uganda
Francis Mmiro 256-41-533-202
Chitungwiza Clinics
Harare, ,
Zimbabwe
Tsungai Chipato 263-4-704890
Muhimbili Hospital
Dar es Salaam, ,
Tanzania
Karim Manji 255-22-2150503
Additional Information:
Study ID Numbers: HPTN 046;
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074412
Other Hiv Seronegativity Studies:
1. Comparison of Stavudine Used Alone or in Combination with Didanosine in HIV-Infected Children
2. The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
3. A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients with HIV-Associated Immune Thrombocytopenic Purpura
4. A Study of the Safety and Effectiveness of an HIV Vaccine for HIV-Positive Patients Receiving Anti-HIV Drugs for at Least 2 Years
5. Immune Therapies and Anti-HIV Therapy Withdrawal in Controlling Viral Load
Related Studies:
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Other Clinical Trials
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Using Nevirapine to Prevent Mother-to-Child HIV Transmission During Breastfeeding
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