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NCT00100867 Clinical Trial

Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00100867
Other study ID # ACTG A5190-P1054
Secondary ID 1U01AI068636
Status Completed
Phase N/A
First received January 6, 2005
Last updated March 31, 2016
Start date June 2006
Est. completion date May 2010

Study information
Verified date March 2016
Source AIDS Clinical Trials Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 236
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Botswana The Gaborone BHP Study Clinic Gaborone
Botswana The Molepolole BHP Study Clinic Gaborone
Brazil Hospital dos Servidores do Estado Rio de Janeiro
Brazil Hospital Geral de Nova Iguacu Rio de Janeiro
Brazil Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz Rio de Janeiro,
India 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
Malawi Univ. of Malawi, John Hopkins Project Blantyre
Malawi University of North Carolina Project (UNC Project) Lilongwe
Peru Asociacion Civil IMPACTA Salud y Educacion, Lince Lima
Peru Asociacion Civil IMPACTA Salud y Educacion, Miraflores Lima
South Africa Perinatal HIV Research Unit at Chris Baragwanath Hospital Johannesburg
South Africa University of the Witwatersrand Johannesburg
Thailand Bhumibol Adulyadej Hospital, Bangkok Bangkok
Thailand Siriraj Hospital Bangkok Noi Bankok
Thailand Chiang Mai University Chang Mai
Thailand Institut de Recherche pour Developpement (IRD) Chiang Mai
Thailand Chonburi Regional Hospital, Chonburi Muang Chonburi
Thailand Prapokklao Hospital Chantaburi Muang Chantaburi
Thailand Phayao Provincial Hospital, Phayao Tambol Mae Sai Muang Phayao
Zimbabwe University of Zimbabwe Harare

Sponsors (2)
Lead Sponsor Collaborator
AIDS Clinical Trials Group National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

Botswana,  Brazil,  India,  Malawi,  Peru,  South Africa,  Thailand,  Zimbabwe, 

References & 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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Sullivan JL. Prevention of mother-to-child transmission of HIV--what next? J Acquir Immune Defic Syndr. 2003 Sep;34 Suppl 1:S67-72. Review. — View Citation

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