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

Bone Loss Clinical Trial

— BONE:STAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03916328
• Other study ID #: CO-EU-380-5327
• Status: Recruiting
• Phase: Phase 4
• Start date: December 3, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2023
• Source: MU-JHU CARE
• Contact: Judith Mbanza, MA
• Phone: +256414541044
• Email: jmbanza[@]mujhu.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Bone Loss

Intervention

Drug:
• B/F/TAF
A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®).
• 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.

Locations

Country	Name	City	State
Uganda	MU-JHU Care Limited	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
MU-JHU CARE

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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