drugset / Trial / NCT02367599
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
Phase 4
Completed
48 enrolled
University of California, San Diego
California HIV/AIDS Research Program · collabCity of Long Beach Department of Health and Human Services · collabGilead Sciences · collabUniversity of California, Los Angeles · collabUniversity of Southern California · collab
Non-randomizedSingle-groupOpen-labelOther
Summary
CCTG 595 is an open-label clinical trial of the effect of a text messaging intervention vs. standard of care on adherence to Truvada as PrEP in MSM at increased risk for HIV infection (ClinicalTrials.gov Identifier: NCT01761643). Eligible subjects for this matched case control substudy will receive vitamin D 4000 IU/day for 24 weeks, from week 24 through week 48. In CCTG 595, plasma from participants are being collected and stored at entry and every 12 weeks. These plasma samples will be used to measure P1NP, CTX, PTH, and vitamin D levels in both cases and controls at entry, week 24, and week 48.
Timeline
- Start
- 2014-12-15
- Primary completion
- 2018-06-13
- Completion
- 2018-07-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Vitamin D | Other / unclassified | 4000 iu | — |
Indications
No indication recorded.