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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00100867 |
Purpose
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.
| Condition |
|---|
|
HIV Infections |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Assessment of Safety and Toxicity Among Infants Born to HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World |
Blood and urine collection
| Estimated Enrollment: | 410 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Many HIV-infected women outside the United States enroll in clinical trials that provide them antiretroviral therapy (ART) to prevent mother-to-child transmission of HIV. However, data are limited on the safety, toxicity, and adverse effects that maternal ART may have on infants born to HIV-infected women. This study will monitor the adverse effects and potential benefits of maternal ART on these infants.
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Infants born to HIV-infected women
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Botswana | |
| The Gaborone BHP Study Clinic | |
| Gaborone, Botswana | |
| The Molepolole BHP Study Clinic | |
| Gaborone, Botswana | |
| Brazil | |
| Hospital dos Servidores do Estado | |
| Rio de Janeiro, Brazil, 22261-161 | |
| Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz | |
| Rio de Janeiro,, Brazil, 21045-900 | |
| Hospital Geral de Nova Iguacu | |
| Rio de Janeiro, Brazil | |
| India | |
| YRG Center for AIDS Research and Education | |
| Chennai, India, 60001-7 | |
| NARI AIDS Research Institute, Department of Clinical Science | |
| Pune, India | |
| NARI AIDS Research Institute, Dr. Kotnis Dispensary | |
| Pune, India | |
| NARI-NIV Clinic | |
| Pune, India | |
| Malawi | |
| University of North Carolina Project (UNC Project) | |
| Lilongwe, Malawi | |
| Univ. of Malawi, John Hopkins Project | |
| Blantyre, Malawi | |
| Peru | |
| Asociacion Civil IMPACTA Salud y Educacion, Lince | |
| Lima, Peru, 18 | |
| Peru, Lima | |
| Asociacion Civil IMPACTA Salud y Educacion, | |
| Miraflores, Lima, Peru, 18 | |
| South Africa | |
| University of the Witwatersrand | |
| Johannesburg, South Africa | |
| Perinatal HIV Research Unit at Chris Baragwanath Hospital | |
| Johannesburg, South Africa | |
| Thailand | |
| Chiang Mai University | |
| Chang Mai, Thailand | |
| Bhumibol Adulyadej Hospital, Bangkok | |
| Bangkok, Thailand, 10120 | |
| Prapokklao Hospital Chantaburi | |
| Muang Chantaburi, Thailand, 22000 | |
| Institut de Recherche pour Developpement (IRD) | |
| Chiang Mai, Thailand, 50200 | |
| Thailand, Bankok | |
| Siriraj Hospital | |
| Bangkok Noi, Bankok, Thailand, 10700 | |
| Thailand, Chonburi | |
| Chonburi Regional Hospital, Chonburi | |
| Muang, Chonburi, Thailand, 20000 | |
| Thailand, Muang Phayao | |
| Phayao Provincial Hospital, Phayao | |
| Tambol Mae Sai, Muang Phayao, Thailand, 56000 | |
| Zimbabwe | |
| University of Zimbabwe | |
| Harare, Zimbabwe | |
| 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 |
More Information
| Responsible Party: | DAIDS ( Rona Siskind ) |
| Study ID Numbers: | ACTG A5190-P1054, ACTG A5190, PACTG P1054 |
| Study First Received: | January 6, 2005 |
| Last Updated: | December 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00100867 |
| Health Authority: | United States: Federal Government |
|
Perinatal Transmission Mother-to-Child Transmission |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |
