MedTrace Logo

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

NCT03916328 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2023-04-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • MU-JHU CARE

    lead OTHER

Principal Investigators

  • Flavia Kiweewa Matovu, MBChB, MSc · MU-JHU CARE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-03
Primary Completion
2024-03-31
Completion
2024-03-31
FDA Drug
Yes

Countries

  • Uganda

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916328 on ClinicalTrials.gov