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

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ClinicalTrials.gov Identifier: NCT03916328
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
MU-JHU CARE

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®).

Condition or disease Intervention/treatment Phase
Bone Loss Drug: B/F/TAF Drug: TDF/3TC/EFV or DTG or NVP Other: DMPA Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 7, 2019
Estimated Primary Completion Date : June 6, 2022
Estimated Study Completion Date : June 6, 2022

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 Name: Depo-provera

Experimental: DMPA+ and B/F/TAF+
HIV-infected women on DMPA, 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 Name: Biktarvy®)

Other: DMPA
Two thirds of the women will be on DMPA for contraception.
Other Name: Depo-provera

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 Name: Biktarvy®)




Primary Outcome Measures :
  1. Changes in bone mineral density [ Time Frame: 2 years ]
    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. Changes in trabeculae bone score (TBS) [ Time Frame: 2 years ]
    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


Secondary Outcome Measures :
  1. Changes in bone biomarkers [ Time Frame: 2 years ]
    We will compare changes in bone turnover markers (CTX and P1NP) in B/F/TAF switchers with and without DMPA use



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   20 - 40 year old HIV-infected non pregnant women
Accepts Healthy Volunteers:   No
Criteria

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
  • 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.).

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Responsible Party: MU-JHU CARE
ClinicalTrials.gov Identifier: NCT03916328     History of Changes
Other Study ID Numbers: CO-EU-380-5327
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Tenofovir
Anti-Retroviral Agents
Medroxyprogesterone Acetate
Medroxyprogesterone
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral