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Bone Health in Aging HIV Infected Women

NCT02815566 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-12-19

Study results available
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Summary

Design: Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for \> 6 months to : 1. Immediate switch of TDF/FTC to tenofovir alafenamide-emtricitabine (TAF/FTC) while continuing the third antiretroviral agent.; 2. Delayed switch; with switch of TDF/FTC to TAF/FTC at 48 weeks while continuing the third agent. Follow up of all subjects to 96 weeks.

Subject Population: The anticipated sample size is 128 HIV infected women aged 45-55 years (peri or early post menopause). .

Primary endpoint: Percentage change from baseline bone mineral density (BMD) at the lumbar spine at weeks 48 and 96.

Secondary Endpoints: BMD change at hip, trabecular bone score, estimated bone strength by high resolution peripheral quantitative computerized tomography (HR-pQCT), muscle quality, geriatric assessment; biomarkers of bone, immune activation and inflammation; HIV viral suppression; safety, lipid and renal function, cardiovascular risk scores at weeks 48 and 96.

Expected Outcomes: To determine if a switch from TDF/FTC to TAF?FTC improves BMD to a degree correlating with a decreased risk of fragility fracture in aging HIV infected women. Secondary outcomes will assess bone strength using new imaging modalities, timing of switch, and renal health. This data will be used by health policy makers and providers to determine the proper use of TAF/FTC in the aging HIV population.

Conditions

Interventions

DRUG

tenofovir-alafenamide-emtricitabine

comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density

DRUG

tenofovir-emtricitabine

comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density

Sponsors & Collaborators

  • University of Modena and Reggio Emilia

    collaborator OTHER

  • San Raffaele University Hospital, Italy

    collaborator OTHER

  • Gilead Sciences

    collaborator INDUSTRY

  • CIHR Canadian HIV Trials Network

    collaborator NETWORK

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • sharon walmsley, MD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2021-02-25
Completion
2021-02-25
FDA Drug
Yes

Countries

  • Canada
  • Italy

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02815566 on ClinicalTrials.gov