Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-21 @ 2:55 PM
Study NCT ID:
NCT00100867
Status:
COMPLETED
Last Update Posted:
2016-04-01
First Post:
2005-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and urine collection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-31', 'studyFirstSubmitDate': '2005-01-06', 'studyFirstSubmitQcDate': '2005-01-06', 'lastUpdatePostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Perinatal Transmission', 'Mother-to-Child Transmission'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '15595430', 'type': 'BACKGROUND', '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.'}, {'pmid': '15332429', 'type': 'BACKGROUND', '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.'}, {'pmid': '15534442', 'type': 'BACKGROUND', '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.'}, {'pmid': '14562860', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nStudy 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.', 'detailedDescription': '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.\n\nNo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants born to HIV-infected women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Parent or guardian willing to provide informed consent\n\nExclusion Criteria:\n\n* Infant with no exposure to antiretrovirals OR who received only intrapartum antiretroviral exposure'}, 'identificationModule': {'nctId': 'NCT00100867', 'briefTitle': 'Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women', 'organization': {'class': 'NETWORK', 'fullName': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections'}, 'officialTitle': 'Assessment of Safety and Toxicity Among Infants Born to HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World', 'orgStudyIdInfo': {'id': 'ACTG A5190-P1054'}, 'secondaryIdInfos': [{'id': '1U01AI068636', 'link': 'https://reporter.nih.gov/quickSearch/1U01AI068636', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaborone', 'country': 'Botswana', 'facility': 'The Gaborone BHP Study Clinic', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}, {'city': 'Gaborone', 'country': 'Botswana', 'facility': 'The Molepolole BHP Study Clinic', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}, {'zip': '21045-900', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Fundacao Oswaldo Cruz', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '22261-161', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital dos Servidores do Estado', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Geral de Nova Iguacu', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '60001-7', 'city': 'Chennai', 'country': 'India', 'facility': 'YRG Center for AIDS Research and Education', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'city': 'Pune', 'country': 'India', 'facility': 'NARI AIDS Research Institute, Department of Clinical Science', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Pune', 'country': 'India', 'facility': 'NARI AIDS Research Institute, Dr. Kotnis Dispensary', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Pune', 'country': 'India', 'facility': 'NARI-NIV Clinic', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Univ. of Malawi, John Hopkins Project', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}, {'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'University of North Carolina Project (UNC Project)', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}, {'zip': '18', 'city': 'Miraflores', 'state': 'Lima region', 'country': 'Peru', 'facility': 'Asociacion Civil IMPACTA Salud y Educacion,', 'geoPoint': {'lat': -12.11331, 'lon': -77.03274}}, {'zip': '18', 'city': 'Lima', 'country': 'Peru', 'facility': 'Asociacion Civil IMPACTA Salud y Educacion, Lince', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Perinatal HIV Research Unit at Chris Baragwanath Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'University of the Witwatersrand', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '10700', 'city': 'Bangkok Noi', 'state': 'Bankok', 'country': 'Thailand', 'facility': 'Siriraj Hospital', 'geoPoint': {'lat': 13.76266, 'lon': 100.47798}}, {'zip': '20000', 'city': 'Muang', 'state': 'Changwat Chon Buri', 'country': 'Thailand', 'facility': 'Chonburi Regional Hospital, Chonburi'}, {'zip': '56000', 'city': 'Tambol Mae Sai', 'state': 'Muang Phayao', 'country': 'Thailand', 'facility': 'Phayao Provincial Hospital, Phayao'}, {'zip': '10120', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Bhumibol Adulyadej Hospital, Bangkok', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Chang Mai', 'country': 'Thailand', 'facility': 'Chiang Mai University'}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Institut de Recherche pour Developpement (IRD)', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '22000', 'city': 'Muang Chantaburi', 'country': 'Thailand', 'facility': 'Prapokklao Hospital Chantaburi'}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'University of Zimbabwe', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Karin Nielsen, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, Los Angeles'}, {'name': 'Judith S. Currier, MD, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Center for AIDS Research and Education, University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}