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

Last updated: April 6, 2023
Sponsor: MU-JHU CARE
Overall Status: Active - Recruiting

Phase

4

Condition

Periodontitis

Osteopenia

Osteoporosis

Treatment

N/A

Clinical Study ID

NCT03916328
CO-EU-380-5327
  • Ages 20-40
  • Female

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®).

Eligibility Criteria

Inclusion

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 takepart 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 recruitedfrom the health centers where the BONE: CARE participants were receiving HIV care, andthese will be matched to those from the BONE: CARE cohort based on age, duration onART and contraception use.
  • Per participant report, plans to stay in the study catchment area in the next 24months
  • Per participant report, willing to continue using similar contraceptive method as inthe BONE: CARE study.

Exclusion

Exclusion Criteria:

  • Currently pregnant/ breastfeeding or was pregnant/ breastfeeding in the last 6 monthsprior 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

Total Participants: 330
Study Start date:
December 03, 2019
Estimated Completion Date:
March 31, 2024

Connect with a study center

  • MU-JHU Care Limited

    Kampala, +256
    Uganda

    Active - Recruiting

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