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

Phase 4

Recruiting

• Conditions: Bone Loss
• Interventions: Drug: B/F/TAF; Drug: TDF/3TC/EFV or DTG or NVP; Other: DMPA

• Registration Number: NCT03916328
• Lead Sponsor: MU-JHU CARE

Brief 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®).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Study Start: 2019-12-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 330

Inclusion Criteria

• Age 20 through 40 years (inclusive) at screening, verified per site SOPs
• Able and willing to provide written informed consent to be screened for and to take part in the study.
• Able and willing to provide adequate locator information, as defined in site SOPs
• Previously participated in the BONE: CARE study. Additional women will be recruited from the health centers where the BONE: CARE participants were receiving HIV care, and these will be matched to those from the BONE: CARE cohort based on age, duration on ART and contraception use.
• Per participant report, plans to stay in the study catchment area in the next 24 months
• Per participant report, willing to continue using similar contraceptive method as in the BONE: CARE study.

Exclusion Criteria

• Currently pregnant/ breastfeeding or was pregnant/ breastfeeding in the last 6 months prior to screening
• Intentions to get pregnant in the next two years
• History of active tuberculosis
• Pathologic bone fracture not related to trauma (ever)
• Has pre-existing condition known to affect bone metabolism (e.g. thyrotoxicosis, tuberculosis, diabetes mellitus, liver or renal disease)
• Is taking the following medications known to interfere with bone metabolism (steroids, anti-convulsants, bisphosphonates, cancer drugs, etc.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DMPA+ and B/F/TAF+	DMPA	HIV-infected women on DMPA, and B/F/TAF.
DMPA+ and TDF+	DMPA	HIV-infected women on DMPA, and TDF containing ART.
DMPA+ and B/F/TAF+	B/F/TAF	HIV-infected women on DMPA, and B/F/TAF.
DMPA- and B/F/TAF+	B/F/TAF	HIV-infected women on non hormonal contraception, and B/F/TAF.
DMPA+ and TDF+	TDF/3TC/EFV or DTG or NVP	HIV-infected women on DMPA, and TDF containing ART.

Primary Outcome Measures

Name	Time	Method
Changes in trabeculae bone score (TBS)	2 years	We will assess percent change in TBS among DMPA users who switch to B/F/TAF compared to DMPA users remaining on TDF based ART
Changes in bone mineral density	2 years	We will assess percent change in BMD among DMPA users who switch to B/F/TAF compared to DMPA users remaining on TDF based ART

Secondary Outcome Measures

Name	Time	Method
Changes in bone biomarkers	2 years	We will compare changes in bone turnover markers (CTX and P1NP) in B/F/TAF switchers with and without DMPA use

Trial Locations

Locations (1)

MU-JHU Care Limited; 🇺🇬 Kampala, Uganda