Trials / Withdrawn
WithdrawnNCT03549689
Effect of Reducing Nucleotide Exposure on Bone Health (ReNew)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Philip Grant · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open-label, randomized pilot study to assess the effect on bone mineral density (BMD) of a switch from a tenofovir alafenamide-containing antiretroviral regimen to dolutegravir/lamivudine vs. a continuation of the tenofovir alafenamide-containing regimen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dolutegravir (DTG) 50MG/lamivudine (3TC) 300MG FIXED DOSE COMBINATION (FDC) | Participants randomized to the Switch Arm will take DTG 50mg/3TC 300mg FDC once daily with or without food at approximately the same time each day. |
| DRUG | Current tenofovir alafenamide (TAF)-containing ART regimen | Continuation of current TAF-containing ART for 96 weeks. |
Timeline
- Start date
- 2019-08-01
- Primary completion
- 2021-07-01
- Completion
- 2021-07-01
- First posted
- 2018-06-08
- Last updated
- 2021-03-15
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03549689. Inclusion in this directory is not an endorsement.