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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00100867
First received: January 6, 2005
Last updated: September 15, 2010
Last verified: September 2010
  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

Resource links provided by NLM:


Further study details as provided by AIDS Clinical Trials Group:

Biospecimen Retention:   Samples With DNA

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)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Infants born to HIV-infected women

Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100867

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
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 AIDS Research Institute, Department of Clinical Science
Pune, India
NARI AIDS Research Institute, Dr. Kotnis Dispensary
Pune, India
NARI-NIV Clinic
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
University of the Witwatersrand
Johannesburg, South Africa
Perinatal HIV Research Unit at Chris Baragwanath Hospital
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
Sponsors and Collaborators
AIDS Clinical Trials Group
Investigators
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

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

ClinicalTrials.gov processed this record on August 27, 2014