Clinical trial NCT00100867: Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Perinatal Transmission
Mother-to-Child Transmission
Lead sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2005-01-07
Enrollment: 236
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born to HIV-infected women

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: The Gaborone BHP Study Clinic
city: Gaborone
country: Botswana
facility: The Molepolole BHP Study Clinic
city: Rio de Janeiro,
country: Brazil
facility: Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz
city: Rio de Janeiro
country: Brazil
facility: Hospital dos Servidores do Estado
city: Rio de Janeiro
country: Brazil
facility: Hospital Geral de Nova Iguacu
city: Chennai
country: India
facility: YRG Center for AIDS Research and Education
city: Pune
country: India
facility: NARI AIDS Research Institute, Department of Clinical Science
city: Pune
country: India
facility: NARI AIDS Research Institute, Dr. Kotnis Dispensary
city: Pune
country: India
facility: NARI-NIV Clinic
city: Blantyre
country: Malawi
facility: Univ. of Malawi, John Hopkins Project
city: Lilongwe
country: Malawi
facility: University of North Carolina Project (UNC Project)
city: Miraflores
country: Peru
facility: Asociacion Civil IMPACTA Salud y Educacion,
state: Lima
city: Lima
country: Peru
facility: Asociacion Civil IMPACTA Salud y Educacion, Lince
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit at Chris Baragwanath Hospital
city: Johannesburg
country: South Africa
facility: University of the Witwatersrand
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bankok
city: Muang
country: Thailand
facility: Chonburi Regional Hospital, Chonburi
state: Chonburi
city: Tambol Mae Sai
country: Thailand
facility: Phayao Provincial Hospital, Phayao
state: Muang Phayao
city: Bangkok
country: Thailand
facility: Bhumibol Adulyadej Hospital, Bangkok
city: Chang Mai
country: Thailand
facility: Chiang Mai University
city: Chiang Mai
country: Thailand
facility: Institut de Recherche pour Developpement (IRD)
city: Muang Chantaburi
country: Thailand
facility: Prapokklao Hospital Chantaburi
city: Harare
country: Zimbabwe
facility: University of Zimbabwe
Study officials:
affiliation: University of California, Los Angeles
name: Karin Nielsen, MD, MPH
role: STUDY_CHAIR
affiliation: Center for AIDS Research and Education, University of California, Los Angeles
name: Judith S. Currier, MD, MSc
role: STUDY_CHAIR
References:
citation: Abrams EJ. Prevention of mother-to-child transmission of HIV--successes, controversies and critical questions. AIDS Rev. 2004 Jul-Sep;6(3):131-43.
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.
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. doi: 10.1097/00001703-200412000-00006.
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. doi: 10.1097/00126334-200309011-00010.