Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
Status:
Completed
Trial end date:
2018-07-11
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
California Collaborative Treatment Group University of California, San Diego
Collaborators:
California HIV/AIDS Research Program City of Long Beach Department of Health and Human Services Gilead Sciences University of California, Los Angeles University of California, San Diego University of Southern California