Clinical trial NCT02367599: Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
Official title: Effect of Vitamin D Supplementation on Bone Turnover Markers During Tenofovir-Emtricitibine Pre-Exposure Prophylaxis in Men Who Have Sex With Men; A Sub-study of CCTG 595
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patient Adherence
Keywords: PrEP
Pre exposure Prophylaxis
Truvada
CCTG
595
Vitamin D
Bone mineral density
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: University of California, Los Angeles
name: City of Long Beach Department of Health and Human Services
name: California HIV/AIDS Research Program
name: Gilead Sciences
First posted: 2015-02-20
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: A total of 50 HIV-uninfected men who have sex with men (MSM) and male to female (M to F) transgender individuals already enrolled in CCTG 595 will be offered participation in the sub-study at Week 24 of the main study. All subjects enrolled into the sub-study will be provided Vitamin D 4000 IU/day supplements in addition to their PrEP at Weeks 24 and 36; clinic visits will proceed normally per main study protocol. Upon completion of the sub-study subjects will continue on the main study.

The primary endpoint, bone turnover markers, will be measured from Week 24 to Week 48 via plasma samples collected through the main study. Concurrent controls who are not enrolled in the vitamin D substudy who are reporting supplementation with \< 400 IU of vitamin D/day will be matched 1:1 by randomization arm in the CCTG 595 main study (text messaging arm vs. standard of care), age (± 5 years), race/ethnicity, season of study entry, and BMI (± 3 kg/m2).

Eligibility 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

Primary outcomes:
measure: Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels
timeFrame: Weeks 24-48
Secondary outcomes:
measure: Change in CTX-1 Levels
timeFrame: Weeks 24-48
measure: Change in PTH Levels
timeFrame: Weeks 24-48
measure: Change in 25-OH Vitamin D3 Levels
timeFrame: Weeks 24-48
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University Southern California
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
Study officials:
affiliation: CCTG, USC
name: Michael P Dube, MD
role: STUDY_CHAIR
affiliation: UC San Diego AntiViral Research Center (AVRC)
name: Sheldon Morris, MD
role: PRINCIPAL_INVESTIGATOR
References: