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

NCT03916328 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: CO-EU-380-5327
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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®).

Conditions

Bone Loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Changes in bone biomarkers

  2 years

Study Arms (3)

DMPA+ and TDF+

ACTIVE COMPARATOR

HIV-infected women on DMPA, and TDF containing ART.

Drug: TDF/3TC/EFV or DTG or NVP; Other: DMPA

DMPA+ and B/F/TAF+

EXPERIMENTAL

HIV-infected women on DMPA, and B/F/TAF.

Drug: B/F/TAF; Other: DMPA

DMPA- and B/F/TAF+

EXPERIMENTAL

HIV-infected women on non hormonal contraception, and B/F/TAF.

Drug: B/F/TAF

Interventions

B/F/TAF DRUG

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

Also known as: Biktarvy®)

DMPA+ and B/F/TAF+; DMPA- and B/F/TAF+

TDF/3TC/EFV or DTG or NVP DRUG

A third of the women will remain on Tenofovir Disoproxil Fumurate.(TDF) containing ART.

DMPA+ and TDF+

DMPA OTHER

Two thirds of the women will be on DMPA for contraception.

Also known as: Depo-provera

DMPA+ and B/F/TAF+; DMPA+ and TDF+

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: 20 - 40 year old HIV-infected non pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• MU-JHU CARE: lead

Study Sites (1)

MU-JHU Care Limited

Kampala, +256, Uganda

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination; dolutegravir; Nevirapine; N,N-dimethyl-4-anisidine; Medroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Flavia Kiweewa Matovu, MBChB, MSc

  MU-JHU CARE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Mbanza, MA

CONTACT

+256414541044; jmbanza@mujhu.org

Flavia Matovu Kiweewa, MBChB, MSc.

CONTACT

+256414541044; fmatovu@mujhu.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: April 16, 2019
• Study Start: December 3, 2019
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)