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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute on Drug Abuse (NIDA) National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00074412 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Nevirapine Drug: Nevirapine placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Trial to Determine the Efficacy and Safety of an Extended Regimen of Nevirapine in Infants Born to HIV-Infected Women to Prevent Vertical HIV Transmission During Breastfeeding |
Estimated Enrollment: | 1670 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2A: Experimental
For infants: extended treatment with NVP
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Drug: Nevirapine
10 mg/ml oral suspension taken once daily up to 6 months of age. Dosage will increase throughout study.
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2B: Placebo Comparator
For infants: extended treatment with NVP placebo
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Drug: Nevirapine placebo
Oral suspension taken once daily up to 6 months of age
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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.
This study will last approximately 3.5 years. 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. Infants who were randomly assigned to receive a placebo and older than 6 weeks of age as of 08/10/07 OR to receive NVP will continue their treatment assignment. Infants who were randomly assigned to receive a placebo and are 6 weeks of age or less as of 08/10/07 will receive open-label NVP through Day 42 of life. For all other participants, all randomized infants will receive extended NVP through 6 weeks (Day 42) of life. All eligible infants will be randomly assigned to one of two groups at Week 6 following birth. The first group will receive extended NVP treatment; the second group will receive nevirapine placebo. Randomized infants will receive the extended NVP or NVP placebo through the first 6 months of life or until cessation of breastfeeding, whichever occurs earlier. Mothers will be instructed to begin giving their infants their assigned intervention starting at Day 3 to Day 7 postpartum. All mothers and infants outside of the study will be offered the local standard of care antiretroviral (ARV) regimen for the prevention of MTCT, but these ARVs will not be provided by the study.
Follow-up evaluations will be conducted at Weeks 2 and 6 and Months 3, 6, 12, and 18 for mothers, and at Weeks 2, 5, 6, and 8 and Months 3, 4, 5, 6, 9, 12, and 18 for infants. Study visits will include physical examinations, blood tests (including HIV tests), and medical histories. Study participants will be followed for up to 3.5 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Note: As of 08/10/07, the arm assignments for current and new participants have changed. Please see the above description for this trial for more information.
Inclusion Criteria for Mothers:
Exclusion Criteria for Mothers:
Inclusion Criteria for Infants:
Exclusion Criteria for Infants:
South Africa | |
Prince Mshiyeni Hospital | Not yet recruiting |
Durban, South Africa | |
Contact: Vanni Chetty Chettyv1@ukzn.ac.za | |
Principal Investigator: Dhayendre Moodley, PhD | |
CAPRISA Umlazi CRS | Recruiting |
Durban, South Africa | |
Contact: Michelle Singh 27 31 2604339 moodleyj@nu.ac.za | |
Principal Investigator: Dhayendre Moodley, PhD | |
Tanzania | |
Muhimbili Hospital | Not yet recruiting |
Dar es Salaam, Tanzania | |
Contact: Jan Cooper 255-754-620-378 cooperj@hsph.harvard.edu | |
Principal Investigator: Karim Manji, MBBS, Mmed | |
Uganda | |
Mulago Hospital | Recruiting |
Kampala, Uganda | |
Contact: Jim Aizire 256-415-410-44 jaizire@mujhu.org | |
Principal Investigator: Philippa Musoke, MBChB | |
Zimbabwe | |
Chitungwiza Clinics | Recruiting |
Harare, Zimbabwe | |
Contact: Lynda Stranix-Chibanda 263-470-4890 lynda@uz-ucsf.co.zw | |
Principal Investigator: Tsungai Chipato, MD | |
Principal Investigator: Rose Kambarami, MBChB, MSc | |
Principal Investigator: Avinash K Shetty, MBBS, DCH, MD | |
Seke North | Recruiting |
Harare, Zimbabwe | |
Contact: Lynda Stranix-Chibanda 263-470-4890 lynda@uz-ucsf.co.zw |
Study Chair: | Hoosen M. Coovadia, MD, MBBS | Centre for HIV Networking (HIVAN), Nelson Mandela School of Medicine, University of Natal |
Study Chair: | Laura Guay, MD | Johns Hopkins University |
Study Chair: | Wafaie Fawzi, MD, PhD | Department of Nutrition, Harvard School of Public Health |
Study Chair: | Yvonne Maldonado, MD | Stanford University |
Study Chair: | Daya Moodley, MSc, PhD | Department of Obstetrics and Gynaecology, Nelson R Mandela School of Medicine, University of Natal |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | HPTN 046 |
Study First Received: | December 11, 2003 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00074412 |
Health Authority: | United States: Food and Drug Administration |
HIV Seronegativity Treatment Experienced Treatment Naive |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |