Clinical Trials Logo
  1. Home
  2. HIV Infection
  3. NCT01769469

Renal, Endocrine, and Bone Changes in Response to FTC/TDF in Uninfected Young Men Who Have Sex With Men (YMSM).

HIV Infection Clinical Trial

Official title:
Renal, Endocrine, and Bone Changes in Response to Treatment With Coformulated Emtricitabine-Tenofovir for Pre-Exposure HIV Prophylaxis (PrEP) in HIV Uninfected Young Men Who Have Sex With Men.

Clinical Trial Summary

This is a prospective observational cohort sub-study of subjects enrolled in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 110 (NCT01772823) or ATN 113 (NCT01769456), which is a prospective interventional trial.

Clinical Trial Description

This is a prospective observational cohort sub-study of subjects enrolled in the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. All subjects will be followed for at least 48 weeks. Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study will be followed for an additional 48 weeks in the Extension Phase of ATN 110 (NCT01772823) or ATN 113 (NCT01769456) and ATN 117 (NCT01769469). The maximum duration of participation will be 96 weeks.

There is no therapeutic intervention specific to this sub-study, and there are no extra study visits required for participation in this sub-study. Questionnaires will be administered and blood and urine samples for laboratory evaluation of potential emtricitabine (FTC)/tenofovir (TDF) (Truvada®) toxicities will be obtained for this sub-study at visits that are required by the ATN 110 (NCT01772823) or ATN 113 (NCT01769456) study. Measurement of bone mineral density (BMD) and bone mineral content (BMC) by dual-energy X-ray absorptiometry (DXA) scan are planned as a part of the ATN 110 (NCT01772823) and ATN 113 (NCT01769456) studies, and results will be utilized for the analysis in this study. This study does not require extra BMD or BMC measurements. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01769469
Study type Observational
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase
Start date November 2012
Completion date November 2015
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02135419 - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions Phase 3
Active, not recruiting NCT02663856 - My Smart Age With HIV: Smartphone Self-assessment of Frailty
Completed NCT02921516 - Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings N/A
Completed NCT02846402 - Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda N/A
Completed NCT02659306 - Metformin Immunotherapy in HIV Infection Phase 1
Terminated NCT02743598 - Liraglutide for HIV-associated Neurocognitive Disorder Phase 4
Completed NCT02663869 - Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Completed NCT02564341 - Targeting Effective Analgesia in Clinics for HIV - Intervention N/A
Active, not recruiting NCT02302950 - A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas N/A
Completed NCT01852942 - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV Phase 2
Completed NCT01830595 - Lactoferrin Treatment in HIV Patients Phase 2
Terminated NCT01902186 - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir Phase 4
Terminated NCT02109224 - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection Phase 1
Completed NCT02269605 - Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment Phase 1
Completed NCT02525146 - Birmingham Access to Care Study N/A
Completed NCT01946217 - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials N/A
Completed NCT02527135 - Text Messaging to Improve HIV Testing Among Young Women in Kenya N/A
Completed NCT02118168 - Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002 N/A
Active, not recruiting NCT02602418 - Neural Correlates of Working Memory Training for HIV Patients N/A
Completed NCT01702974 - Immune Reconstitution in HIV Disease (IREHIV) Phase 2