Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women
Assessment of Safety and Toxicity Among Infants Born to HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World
2 other identifiers
observational
236
8 countries
23
Brief Summary
In clinical trials being conducted throughout the world, pregnant HIV-infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV. However, the effects of this anti-HIV treatment on infants is unknown. The purpose of this study is to determine the safety, toxicity, and potential side effects of maternal anti-HIV treatment on infants born to these HIV-infected women. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2006
Longer than P75 for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2005
CompletedFirst Posted
Study publicly available on registry
January 7, 2005
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedApril 1, 2016
March 1, 2016
3.9 years
January 6, 2005
March 31, 2016
Conditions
Keywords
Eligibility Criteria
Infants born to HIV-infected women
You may qualify if:
- Infant born to HIV-1 infected mother enrolled in NIH-sponsored, international antiretroviral treatment trial AND who has had either in utero or postpartum antiretroviral exposure
- Parent or guardian willing to provide informed consent
You may not qualify if:
- Infant with no exposure to antiretrovirals OR who received only intrapartum antiretroviral exposure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
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, 21045-900, Brazil
Hospital dos Servidores do Estado
Rio de Janeiro, 22261-161, Brazil
Hospital Geral de Nova Iguacu
Rio de Janeiro, Brazil
YRG Center for AIDS Research and Education
Chennai, 60001-7, 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, 18, Peru
Asociacion Civil IMPACTA Salud y Educacion, Lince
Lima, 18, Peru
Perinatal HIV Research Unit at Chris Baragwanath Hospital
Johannesburg, South Africa
University of the Witwatersrand
Johannesburg, South Africa
Siriraj Hospital
Bangkok Noi, Bankok, 10700, Thailand
Chonburi Regional Hospital, Chonburi
Muang, Changwat Chon Buri, 20000, Thailand
Phayao Provincial Hospital, Phayao
Tambol Mae Sai, Muang Phayao, 56000, Thailand
Bhumibol Adulyadej Hospital, Bangkok
Bangkok, 10120, Thailand
Chiang Mai University
Chang Mai, Thailand
Institut de Recherche pour Developpement (IRD)
Chiang Mai, 50200, Thailand
Prapokklao Hospital Chantaburi
Muang Chantaburi, 22000, Thailand
University of Zimbabwe
Harare, Zimbabwe
Related Publications (4)
Abrams EJ. Prevention of mother-to-child transmission of HIV--successes, controversies and critical questions. AIDS Rev. 2004 Jul-Sep;6(3):131-43.
PMID: 15595430BACKGROUNDScarlatti G. Mother-to-child transmission of HIV-1: advances and controversies of the twentieth centuries. AIDS Rev. 2004 Apr-Jun;6(2):67-78.
PMID: 15332429BACKGROUNDSemprini 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.
PMID: 15534442BACKGROUNDSullivan 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.
PMID: 14562860BACKGROUND
Biospecimen
Blood and urine collection
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Karin Nielsen, MD, MPH
University of California, Los Angeles
- STUDY CHAIR
Judith S. Currier, MD, MSc
Center for AIDS Research and Education, University of California, Los Angeles
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2005
First Posted
January 7, 2005
Study Start
June 1, 2006
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
April 1, 2016
Record last verified: 2016-03