Ignite Creation Date:
2024-05-06 @ 1:03 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03916328
Status:
RECRUITING
Last Update Posted:
2023-04-07
First Post:
2018-10-19
Brief Title:
BONE STAR Switching to TAF Based Anti-Retroviral Therapy Study
Sponsor:
MU-JHU CARE
Organization:
MU-JHU CARE
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BONESTAR
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 BFTAF Biktarvy in a randomized fashion HIV infected women on TDF and non-hormonal contraception will be switched to Biktarvy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None