Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women
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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: | Observational Model: Cohort Time Perspective: 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 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 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:
- 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
Exclusion Criteria:
- Infant with no exposure to antiretrovirals OR who received only intrapartum antiretroviral exposure
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00100867
| 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 | |
| Hospital Geral de Nova Iguacu | |
| Rio de Janeiro, Brazil | |
| Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz | |
| Rio de Janeiro,, Brazil, 21045-900 | |
| India | |
| YRG Center for AIDS Research and Education | |
| Chennai, India, 60001-7 | |
| NARI-NIV Clinic | |
| Pune, India | |
| NARI AIDS Research Institute, Dr. Kotnis Dispensary | |
| Pune, India | |
| NARI AIDS Research Institute, Department of Clinical Science | |
| Pune, India | |
| Malawi | |
| Univ. of Malawi, John Hopkins Project | |
| Blantyre, Malawi | |
| University of North Carolina Project (UNC Project) | |
| Lilongwe, Malawi | |
| Peru | |
| Asociacion Civil IMPACTA Salud y Educacion, | |
| Miraflores, Lima, Peru, 18 | |
| Asociacion Civil IMPACTA Salud y Educacion, Lince | |
| Lima, Peru, 18 | |
| South Africa | |
| Perinatal HIV Research Unit at Chris Baragwanath Hospital | |
| Johannesburg, South Africa | |
| University of the Witwatersrand | |
| Johannesburg, South Africa | |
| Thailand | |
| Siriraj Hospital | |
| Bangkok Noi, Bankok, Thailand, 10700 | |
| Chonburi Regional Hospital, Chonburi | |
| Muang, Chonburi, Thailand, 20000 | |
| Phayao Provincial Hospital, Phayao | |
| Tambol Mae Sai, Muang Phayao, Thailand, 56000 | |
| Bhumibol Adulyadej Hospital, Bangkok | |
| Bangkok, Thailand, 10120 | |
| Chiang Mai University | |
| Chang Mai, Thailand | |
| Institut de Recherche pour Developpement (IRD) | |
| Chiang Mai, Thailand, 50200 | |
| Prapokklao Hospital Chantaburi | |
| Muang Chantaburi, Thailand, 22000 | |
| 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
Additional Information:
Publications:
| Responsible Party: | Daniel R. Kuritzkes, M.D., Social & Scientific Systems, Inc. |
| ClinicalTrials.gov Identifier: | NCT00100867 History of Changes |
| Other Study ID Numbers: | ACTG A5190-P1054, 1U01AI068636, ACTG A5190, PACTG P1054 |
| Study First Received: | January 6, 2005 |
| Last Updated: | September 15, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by AIDS Clinical Trials Group:
|
Perinatal Transmission Mother-to-Child Transmission |
ClinicalTrials.gov processed this record on February 27, 2015