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

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

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®).

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 330
• Phase: Phase 4

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda, +256
    • Recruiting
    • MU-JHU Care Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DMPA+ and TDF+; HIV-infected women on DMPA, and TDF containing ART.	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.; Other Names: Depo-provera
Experimental: DMPA+ and B/F/TAF+; HIV-infected women on DMPA, and B/F/TAF.	Other: DMPA; Two thirds of the women will be on DMPA for contraception.; Other Names: Depo-provera; Drug: B/F/TAF; A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®).; Other Names: Biktarvy®)
Experimental: DMPA- and B/F/TAF+; HIV-infected women on non hormonal contraception, and B/F/TAF.	Drug: B/F/TAF; A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®).; Other Names: Biktarvy®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in bone mineral density	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	2 years
Changes in trabeculae bone score (TBS)	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	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: MU-JHU CARE

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): March 31, 2024

Study Registration Dates

• First Submitted: October 19, 2018
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents, Male; Medroxyprogesterone Acetate
• Other Study ID Numbers: CO-EU-380-5327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes