Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women
NCT01310023 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5169
Last updated 2025-06-27
Summary
SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers.
Conditions
- Antiretroviral Toxicity
Sponsors & Collaborators
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
National Institute on Drug Abuse (NIDA)
collaborator NIH -
National Institute of Allergy and Infectious Diseases (NIAID)
collaborator NIH -
National Institute of Mental Health (NIMH)
collaborator NIH -
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
National Institute on Deafness and Other Communication Disorders (NIDCD)
collaborator NIH -
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH -
National Institute of Neurological Disorders and Stroke (NINDS)
collaborator NIH -
Tulane University School of Medicine
collaborator OTHER -
National Institute of Dental and Craniofacial Research (NIDCR)
collaborator NIH -
NIH Office of AIDS Research (OAR)
collaborator NIH -
Harvard School of Public Health (HSPH)
lead OTHER
Principal Investigators
-
Paige L Williams · Harvard School of Public Health (HSPH)
-
Ellen Chadwick, M.D. · Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-03-31
- Primary Completion
- 2025-05-31
- Completion
- 2025-05-31
Countries
- United States
- Puerto Rico
Study Locations
More Related Trials
-
The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study
NCT04087239 ·Status: ACTIVE_NOT_RECRUITING
-
Adolescent Master Protocol
NCT01418014 ·Status: COMPLETED
-
Long Term Outcomes of Therapy in Women Initiated on Lifelong ART Because of Pregnancy in DR Congo
NCT03048669 ·Status: COMPLETED ·Phase: NA
-
A Study of Zidovudine in Infants Exposed to the HIV Before or Soon After Birth
NCT00001007 ·Status: COMPLETED ·Phase: PHASE1
-
Therapeutic Drug Monitoring and Viral Resistance Testing in the Treatment of HIV-Infected Children
NCT00032669 ·Status: COMPLETED ·Phase: PHASE1
-
Immune Function of Infants With HIV
NCT00073229 ·Status: COMPLETED
-
POC HIV Testing and Early DTG Use for Infants
NCT05393193 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Non-virologic Methods to Diagnose Treatment Eligibility in HIV-exposed Infants
NCT01222130 ·Status: COMPLETED
-
Long-term Effects of Highly Active Anti-Retroviral Therapy on HIV-Infected Children
NCT00260806 ·Status: COMPLETED
-
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
NCT01618305 ·Status: COMPLETED ·Phase: PHASE4
-
A Prospective, Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries
NCT00341302 ·Status: COMPLETED
-
Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
NCT06517693 ·Status: RECRUITING ·Phase: PHASE1
-
HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure
NCT03642704 ·Status: COMPLETED ·Phase: PHASE4
-
Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
NCT00115648 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
NCT05406583 ·Status: COMPLETED ·Phase: PHASE1
-
Stopping and Restarting Anti-HIV Drugs in Children and Adolescents With Low Blood Levels of HIV
NCT00016783 ·Status: COMPLETED
-
Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
NCT00000828 ·Status: COMPLETED
-
A Study to Collect Information About HIV-Positive Pregnant Women and Their Babies
NCT00000910 ·Status: COMPLETED
-
HIV Exposure in Utero and Metabolic Disease Risk in HIV-Negative Young Adults
NCT04132830 ·Status: COMPLETED
-
IMPAACT 1077HS: Examining Benefits of HAART Continuation in Postpartum Women
NCT00955968 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.
NCT00000855 ·Status: COMPLETED ·Phase: NA
-
Monitoring Highly Active Antiretroviral Therapy in HIV-infected Parents in Thailand
NCT00162682 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants
NCT00038480 ·Status: COMPLETED ·Phase: PHASE1
-
Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women
NCT01621347 ·Status: COMPLETED
-
HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV
NCT00442962 ·Status: COMPLETED ·Phase: PHASE4