Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM

• Status: Completed
• Trial end date: 2018-07-11
• Target enrollment: 0
• Participant gender: Male

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• All subjects must meet CCTG 595 inclusion criteria.

Exclusion Criteria:

• All subjects must meet CCTG 595 exclusion criteria.

• Current or prior use of bisphosphonate therapy.

• Current use of Vitamin D supplements greater than 400 IU/day.

• Current use of androgenic hormones or growth hormones.

• History of nephrolithiasis (kidney stones).

• History of fragility fracture.

• No use of tenofovir prior to entry into CCTG 595