Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT01066858
Status:
COMPLETED
Last Update Posted:
2022-09-23
First Post:
2010-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India', 'Tanzania', 'Zambia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D001942', 'term': 'Breast Feeding'}], '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'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1765}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-22', 'studyFirstSubmitDate': '2010-02-09', 'studyFirstSubmitQcDate': '2010-02-09', 'lastUpdatePostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antepartum Component: Creatinine clearance (CrCl)', 'timeFrame': 'For women and infants: at delivery/birth, up to Week 1', 'description': 'Antepartum Component: Creatinine clearance (CrCl)'}, {'measure': 'Antepartum Component: Bone resorption (Dpyr)', 'timeFrame': 'For women and infants: at delivery/birth, up to Week 1', 'description': 'Antepartum Component: Bone resorption (Dpyr)'}, {'measure': 'Antepartum Component: Lumbar spine bone mineral density (BMD) via dual energy e-ray absorptiometry (DXA)', 'timeFrame': 'For women: at delivery/birth, up to Week 1', 'description': 'Antepartum Component: Lumbar spine bone mineral density (BMD) via dual energy e-ray absorptiometry (DXA)'}, {'measure': 'Antepartum Component: Lumbar spine bone mineral content (BMC) and whole body BMC via DXA', 'timeFrame': 'For infants: at delivery/birth, up to Week 1', 'description': 'Antepartum Component: Lumbar spine bone mineral content (BMC) and whole body BMC via DXA'}, {'measure': 'Antepartum Component: Length-for-age Z-score', 'timeFrame': 'For infants: at delivery/birth, up to Week 1 and Week 26', 'description': 'Antepartum Component: Length-for-age Z-score'}, {'measure': 'Postpartum Component: CrCl', 'timeFrame': 'For women: at postpartum entry (delivery/birth, up to Week 1) and Week 74; for infants: at Week 26', 'description': 'Postpartum Component: CrCl'}, {'measure': 'Postpartum Component: Dpyr', 'timeFrame': 'For women: at Week 74; for infants: at Week 26', 'description': 'Postpartum Component: Dpyr'}, {'measure': 'Postpartum Component: Lumbar spine BMD via DXA', 'timeFrame': 'For women: at postpartum entry (delivery/birth, up to Week 1) and Week 74', 'description': 'Postpartum Component: Lumbar spine BMD via DXA'}, {'measure': 'Postpartum Component: Lumbar spine BMC via DXA', 'timeFrame': 'For infants: at Week 26', 'description': 'Postpartum Component: Lumbar spine BMC via DXA'}, {'measure': 'Postpartum Component: Length-for-age Z-score', 'timeFrame': 'For infants: at postpartum entry (delivery/birth, up to Week 1) and Week 26', 'description': 'Postpartum Component: Length-for-age Z-score'}], 'secondaryOutcomes': [{'measure': 'CrCl', 'timeFrame': 'For women: Weeks 6, 26, and 74; for infants: at Weeks 10, 26, and 74', 'description': 'CrCl'}, {'measure': 'BMD', 'timeFrame': 'For women: at delivery and change in hip BMD from delivery to Week 74', 'description': 'BMD'}, {'measure': 'Dpyr', 'timeFrame': 'For women: at Weeks 6, 26, and 74; for infants: at Weeks 10, 26, and 74', 'description': 'Dpyr'}, {'measure': 'Mineral composition of breast milk', 'timeFrame': 'For women: at Weeks 1, 6, 26, and 74', 'description': 'Mineral composition of breast milk'}, {'measure': 'Lumbar spine BMC', 'timeFrame': 'For infants: Week 26', 'description': 'Lumbar spine BMC'}, {'measure': 'Infant growth', 'timeFrame': 'For infants: at Weeks 10 and 74', 'description': 'Infant growth'}, {'measure': 'Concentration of hormonal growth factors (for infants)', 'timeFrame': 'For infants: at birth and Weeks 10, 26, and 74', 'description': 'Concentration of hormonal growth factors (for infants)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tenofovir', 'renal and bone toxicity', 'pregnancy', 'breastfeeding', 'mother to child transmission'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '19459986', 'type': 'BACKGROUND', 'citation': 'Foster C, Lyall H, Olmscheid B, Pearce G, Zhang S, Gibb DM. Tenofovir disoproxil fumarate in pregnancy and prevention of mother-to-child transmission of HIV-1: is it time to move on from zidovudine? HIV Med. 2009 Aug;10(7):397-406. doi: 10.1111/j.1468-1293.2009.00709.x. Epub 2009 May 12.'}, {'pmid': '18957630', 'type': 'BACKGROUND', 'citation': 'Nurutdinova D, Onen NF, Hayes E, Mondy K, Overton ET. Adverse effects of tenofovir use in HIV-infected pregnant women and their infants. Ann Pharmacother. 2008 Nov;42(11):1581-5. doi: 10.1345/aph.1L083. Epub 2008 Oct 28.'}, {'pmid': '35858874', 'type': 'DERIVED', 'citation': 'Baltrusaitis K, Makanani B, Tierney C, Fowler MG, Moodley D, Theron G, Nyakudya LH, Tomu M, Fairlie L, George K, Heckman B, Knowles K, Browning R, Siberry GK, Taha TE, Stranix-Chibanda L; PROMISE P1084s Study Team. Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial. BMC Infect Dis. 2022 Jul 20;22(1):634. doi: 10.1186/s12879-022-07608-8.'}, {'pmid': '33544759', 'type': 'DERIVED', 'citation': 'Stranix-Chibanda L, Tierney C, Sebikari D, Aizire J, Dadabhai S, Zanga A, Mukwasi-Kahari C, Vhembo T, Violari A, Theron G, Moodley D, George K, Fan B, Sommer MJ, Browning R, Mofenson LM, Shepherd J, Nelson B, Fowler MG, Siberry GK; PROMISE P1084s study team. Impact of postpartum tenofovir-based antiretroviral therapy on bone mineral density in breastfeeding women with HIV enrolled in a randomized clinical trial. PLoS One. 2021 Feb 5;16(2):e0246272. doi: 10.1371/journal.pone.0246272. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and while breastfeeding. The study will also look at the changes in overall health, bone health and how the kidneys work in the infants of these women.', 'detailedDescription': 'A small number of adults (who are not pregnant) and children who take anti-HIV medications develop problems with their kidneys and with the strength of their bones. These problems may be more common when tenofovir disoproxil fumarate (TDF) is used. Studies about these bone and kidney effects have not been done in pregnant and breastfeeding women and their infants.\n\nThis is a substudy of a larger study (IMPAACT 1077 PROMISE \\[Promoting Maternal and Infant Survival Everywhere\\]) to evaluate the safety of anti-HIV medications used in pregnancy and during breastfeeding. Only participants in the larger study randomly assigned to receive maternal tenofovir disoproxil fumarate (TDF) or no maternal TDF during pregnancy or during breastfeeding will be enrolled in this substudy.\n\nThis substudy will look at two groups of participants:\n\n* An antepartum exposure group to look at the effects of TDF during pregnancy\n* A postpartum exposure group to look at the effects of TDF during breastfeeding\n\nAll mother-infant pairs in the substudy will be followed for 74 weeks after delivery. During this time, the women and their infants will have medical checkups and tests. The tests will include tests of blood, urine, cord blood, and breast milk. Some of the women and infants will have a special x-ray called a dual energy e-ray absorptiometry (DXA) scan to measure bone strength. The timing of the tests-at enrollment, at delivery, at 6, 10, 26, or 74 weeks-will vary dependent on which part of this substudy women and infants are enrolled in. Those in charge of the substudy will try to schedule medical visits and tests at the same time as tests scheduled for the larger IMPAACT 1077 study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For antepartum (AP) exposure part of P1084s: Mother/infant pairs enrolled in the antepartum components of 1077BF or 1077FF (1077BA and 1077FA respectively) at African clinical sites approved as P1084s DXA sites.\n\nFor postpartum (PP) exposure part of P1084s: Mothers and their infants enrolled in the postpartum component of 1077BF (107BP) at African clinical sites approved as P1084s DXA sites.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Antepartum (AP) Part of Study (TDF Exposure During Pregnancy)\n\nInclusion Criteria:\n\n* Mother-infant pair enrolled in 1077BA or 1077FA\n* At a clinical site that has been approved as a P1084s DXA site\n* Enrolled in the substudy up to the Week 2 visit of 1077BA/1077FA (within 21 days after 1077BA/1077FA study entry) and prior to the start of labor\n* Willing and able to provide written informed consent to participate in this substudy\n\nExclusion Criteria:\n\n* None\n\nPostpartum (PP) Part of Substudy (TDF Exposure During Breastfeeding) (Note: this applies only to the new enrollment to P1084s, i.e., those who were not enrolled to P1084s while on the AP component)\n\nInclusion Criteria:\n\n* Mother and their infant enrolled in 1077BP\n* At a clinical site that has been approved as a P1084s DXA site\n* Enrolled in the substudy within 6 to 14 days of delivery, on the same day as enrollment in 1077BP\n* Willing and able to provide written informed consent to participate in this substudy\n\nExclusion Criteria:\n\n* TDF exposure during pregnancy \\[NOTE: TDF use for up to 12 days beginning at labor allowed\\]\n* Enrolled in the AP part of P1084s'}, 'identificationModule': {'nctId': 'NCT01066858', 'briefTitle': 'Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere)', 'orgStudyIdInfo': {'id': 'P1084s (PROMISE)'}, 'secondaryIdInfos': [{'id': '10790', 'type': 'REGISTRY', 'domain': 'DAIDS ES'}, {'id': 'IMPAACT P1084s'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Maternal/infant antepartum exposure', 'description': '* HIV-infected women exposed to TDF during pregnancy\n* Infants of HIV-infected women exposed to TDF during pregnancy', 'interventionNames': ['Drug: Tenofovir disoproxil fumarate (TDF)']}, {'label': 'Maternal/infant postpartum exposure', 'description': '* HIV-infected women exposed to TDF while breastfeeding\n* Infants of HIV-infected women exposed to TDF while breastfeeding', 'interventionNames': ['Drug: Tenofovir disoproxil fumarate (TDF)']}, {'label': 'Maternal/infant antepartum no exposure', 'description': '* HIV-infected women not exposed to TDF during pregnancy\n* Infants of HIV-infected women not exposed to TDF during pregnancy'}, {'label': 'Maternal/infant postpartum no exposure', 'description': '* HIV-infected women not exposed to TDF during breastfeeding\n* Infants of HIV-infected women not exposed to TDF during breastfeeding'}], 'interventions': [{'name': 'Tenofovir disoproxil fumarate (TDF)', 'type': 'DRUG', 'description': 'Some participants will receive varying doses of TDF during pregnancy or breastfeeding as part of the larger study (IMPAACT 1077 PROMISE).', 'armGroupLabels': ['Maternal/infant antepartum exposure', 'Maternal/infant postpartum exposure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Blantyre CRS', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}, {'city': 'Lilongwe', 'country': 'Malawi', 'facility': 'Malawi CRS', 'geoPoint': {'lat': -13.96692, 'lon': 33.78725}}, {'zip': '1862', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Soweto IMPAACT CRS', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2001', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Shandukani Research CRS', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '4001', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Durban Paediatric HIV CRS', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '4001', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Umlazi CRS', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '7505', 'city': 'Tygerberg', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Family Clinical Research Unit (FAM-CRU) CRS'}, {'city': 'Kampala', 'state': 'Mpigi', 'country': 'Uganda', 'facility': 'MU-JHU Research Collaboration (MUJHU CARE LTD) CRS', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Chitungwiza', 'country': 'Zimbabwe', 'facility': 'Seke North CRS', 'geoPoint': {'lat': -18.01274, 'lon': 31.07555}}, {'city': 'Chitungwiza', 'country': 'Zimbabwe', 'facility': "St Mary's CRS", 'geoPoint': {'lat': -18.01274, 'lon': 31.07555}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'Harare Family Care CRS', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'George K. Siberry, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'NICHD/NIH'}, {'name': 'Lynda Stranix-Chibanda, MBChB, MMED', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Zimbabwe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}