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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00100867
Recruitment Status : Completed
First Posted : January 7, 2005
Last Update Posted : April 1, 2016
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

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.

Condition or disease
HIV Infections

Detailed 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.

Study Type : Observational
Actual Enrollment : 236 participants
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
Study Start Date : June 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Biospecimen Retention:   Samples With DNA
Blood and urine collection

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00100867

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, 21045-900
Hospital dos Servidores do Estado
Rio de Janeiro, Brazil, 22261-161
Hospital Geral de Nova Iguacu
Rio de Janeiro, Brazil
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
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, 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
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
University of Zimbabwe
Harare, Zimbabwe
Sponsors and Collaborators
AIDS Clinical Trials Group
National Institute of Allergy and Infectious Diseases (NIAID)
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

Responsible Party: AIDS Clinical Trials Group Identifier: NCT00100867     History of Changes
Other Study ID Numbers: ACTG A5190-P1054
1U01AI068636 ( U.S. NIH Grant/Contract )
First Posted: January 7, 2005    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016

Keywords provided by AIDS Clinical Trials Group:
Perinatal Transmission
Mother-to-Child Transmission

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases