NCT03916328

BONE: STAR (Switching to TAF Based Anti-Retroviral Therapy) Study

A Phase IV Open-Label Trial to Assess Bone Mineral Density in a Cohort of African Women on Depo-provera and Tenofovir Disoproxil Fumurate Switched to Tenofovir Alafenamide Fumarate Based Anti-Retroviral Therapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: MU-JHU CARE · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The primarily objective of this study is to assess the effect of switching from Tenofovir Disoproxil Fumurate (TDF) to TAF based ART on bone mass and turnover among women on DMPA for contraception. HIV virologically suppressed women on DMPA will be switched from their TDF based regimen to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®) in a randomized fashion. HIV infected women on TDF and non-hormonal contraception will be switched to Biktarvy®).

Conditions

• Bone Loss

Interventions

Type	Name	Description
DRUG	B/F/TAF	A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®).
DRUG	TDF/3TC/EFV or DTG or NVP	A third of the women will remain on Tenofovir Disoproxil Fumurate.(TDF) containing ART.
OTHER	DMPA	Two thirds of the women will be on DMPA for contraception.

Timeline

• Start date: 2019-12-03
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2019-04-16
• Last updated: 2023-04-07

Locations

1 site across 1 country: Uganda

Regulatory

• FDA-regulated drug study