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Last Updated: December 6, 2021

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CLINICAL TRIALS PROFILE FOR DESCOVY

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All Clinical Trials for DESCOVY

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02815566 ↗ Bone Health in Aging HIV Infected Women Active, not recruiting CIHR Canadian HIV Trials Network Phase 4 2017-09-12 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.
NCT02815566 ↗ Bone Health in Aging HIV Infected Women Active, not recruiting Gilead Sciences Phase 4 2017-09-12 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.
NCT02815566 ↗ Bone Health in Aging HIV Infected Women Active, not recruiting San Raffaele University Hospital, Italy Phase 4 2017-09-12 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for DESCOVY

Condition Name

Condition Name for DESCOVY
Intervention Trials
HIV 5
HIV Infections 2
HIV-1-infection 2
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Condition MeSH

Condition MeSH for DESCOVY
Intervention Trials
HIV Infections 2
Coronavirus Infections 1
Renal Insufficiency, Chronic 1
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Clinical Trial Locations for DESCOVY

Trials by Country

Trials by Country for DESCOVY
Location Trials
United States 17
Canada 3
South Africa 3
Netherlands 2
Spain 2
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Trials by US State

Trials by US State for DESCOVY
Location Trials
California 3
Texas 2
Pennsylvania 2
New York 1
North Carolina 1
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Clinical Trial Progress for DESCOVY

Clinical Trial Phase

Clinical Trial Phase for DESCOVY
Clinical Trial Phase Trials
Phase 4 4
Phase 3 3
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for DESCOVY
Clinical Trial Phase Trials
Not yet recruiting 4
Recruiting 4
Completed 3
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Clinical Trial Sponsors for DESCOVY

Sponsor Name

Sponsor Name for DESCOVY
Sponsor Trials
Gilead Sciences 6
Hospital Universitari de Bellvitge 3
Fundacio Lluita Contra la SIDA 2
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Sponsor Type

Sponsor Type for DESCOVY
Sponsor Trials
Other 47
Industry 7
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