Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women
NCT ID: NCT00100867
Last Updated: 2016-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
236 participants
OBSERVATIONAL
2006-06-30
2010-05-31
Brief Summary
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Study hypothesis: Specific combination antiretroviral regimens used in clinical trials in diverse areas of the world are safe and well tolerated during pregnancy and breastfeeding periods, and are not associated with adverse side effects to the fetus, neonate, and/or breastfeeding infant. These regimens are associated with reduction of mother-to-child HIV transmission.
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Detailed Description
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No antiretrovirals will be given in this study. This study will last 18 months. Infants will be enrolled in the study within 48 hours of birth. There will be 6 study visits starting at study entry and every 6 weeks thereafter. Infants will undergo blood and urine collection, and medical history assessments will occur at every visit. Mothers will also be evaluated at these visits.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Parent or guardian willing to provide informed consent
Exclusion Criteria
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
Responsible Party
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Principal Investigators
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Karin Nielsen, MD, MPH
Role: STUDY_CHAIR
University of California, Los Angeles
Judith S. Currier, MD, MSc
Role: STUDY_CHAIR
Center for AIDS Research and Education, University of California, Los Angeles
Locations
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The Gaborone BHP Study Clinic
Gaborone, , Botswana
The Molepolole BHP Study Clinic
Gaborone, , Botswana
Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz
Rio de Janeiro, , Brazil
Hospital dos Servidores do Estado
Rio de Janeiro, , Brazil
Hospital Geral de Nova Iguacu
Rio de Janeiro, , Brazil
YRG Center for AIDS Research and Education
Chennai, , India
NARI AIDS Research Institute, Department of Clinical Science
Pune, , India
NARI AIDS Research Institute, Dr. Kotnis Dispensary
Pune, , India
NARI-NIV Clinic
Pune, , India
Univ. of Malawi, John Hopkins Project
Blantyre, , Malawi
University of North Carolina Project (UNC Project)
Lilongwe, , Malawi
Asociacion Civil IMPACTA Salud y Educacion,
Miraflores, Lima region, Peru
Asociacion Civil IMPACTA Salud y Educacion, Lince
Lima, , Peru
Perinatal HIV Research Unit at Chris Baragwanath Hospital
Johannesburg, , South Africa
University of the Witwatersrand
Johannesburg, , South Africa
Siriraj Hospital
Bangkok Noi, Bankok, Thailand
Chonburi Regional Hospital, Chonburi
Muang, Changwat Chon Buri, Thailand
Phayao Provincial Hospital, Phayao
Tambol Mae Sai, Muang Phayao, Thailand
Bhumibol Adulyadej Hospital, Bangkok
Bangkok, , Thailand
Chiang Mai University
Chang Mai, , Thailand
Institut de Recherche pour Developpement (IRD)
Chiang Mai, , Thailand
Prapokklao Hospital Chantaburi
Muang Chantaburi, , Thailand
University of Zimbabwe
Harare, , Zimbabwe
Countries
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References
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Abrams EJ. Prevention of mother-to-child transmission of HIV--successes, controversies and critical questions. AIDS Rev. 2004 Jul-Sep;6(3):131-43.
Scarlatti G. Mother-to-child transmission of HIV-1: advances and controversies of the twentieth centuries. AIDS Rev. 2004 Apr-Jun;6(2):67-78.
Semprini AE, Fiore S. HIV and pregnancy: is the outlook for mother and baby transformed? Curr Opin Obstet Gynecol. 2004 Dec;16(6):471-5. doi: 10.1097/00001703-200412000-00006.
Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. doi: 10.1097/00126334-200309011-00010.
Other Identifiers
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ACTG A5190-P1054
Identifier Type: -
Identifier Source: org_study_id
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