Bone Loss
Conditions
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®).
Interventions
DRUGB/F/TAF
A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®).
DRUGTDF/3TC/EFV or DTG or NVP
A third of the women will remain on Tenofovir Disoproxil Fumurate.(TDF) containing ART.
OTHERDMPA
Two thirds of the women will be on DMPA for contraception.
Sponsors
MU-JHU CARE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in bone mineral density | 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 |
| Changes in trabeculae bone score (TBS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in bone biomarkers | 2 years | We will compare changes in bone turnover markers (CTX and P1NP) in B/F/TAF switchers with and without DMPA use |
Countries
Uganda
Contacts
Primary ContactJudith Mbanza, MA
Backup ContactFlavia Matovu Kiweewa, MBChB, MSc.
Outcome results
None listed