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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Changes in trabeculae bone score (TBS)
研究概览
简要总结
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®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.).
研究组 & 干预措施
DMPA+ and TDF+
HIV-infected women on DMPA, and TDF containing ART.
干预措施: TDF/3TC/EFV or DTG or NVP (Drug)
DMPA+ and TDF+
HIV-infected women on DMPA, and TDF containing ART.
干预措施: DMPA (Other)
DMPA+ and B/F/TAF+
HIV-infected women on DMPA, and B/F/TAF.
干预措施: B/F/TAF (Drug)
DMPA+ and B/F/TAF+
HIV-infected women on DMPA, and B/F/TAF.
干预措施: DMPA (Other)
DMPA- and B/F/TAF+
HIV-infected women on non hormonal contraception, and B/F/TAF.
干预措施: B/F/TAF (Drug)
结局指标
主要结局
Changes in trabeculae bone score (TBS)
时间窗: 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
Changes in bone mineral density
时间窗: 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
次要结局
- Changes in bone biomarkers(2 years)
研究者
Flavia Kiweewa Matovu
Study Principal Investigator
MU-JHU CARE