Patient Adherence
Conditions
Keywords
PrEP, Pre exposure Prophylaxis, Truvada, CCTG, 595, Vitamin D, Bone mineral density
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).
Interventions
Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks.
Sponsors
University of Southern California
University of California, Los Angeles
City of Long Beach Department of Health and Human Services
California HIV/AIDS Research Program
Gilead Sciences
University of California, San Diego
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All subjects must meet CCTG 595 inclusion criteria.
Exclusion criteria
* All subjects must meet CCTG 595
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels | Weeks 24-48 | To compare the change in P1NP levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CTX-1 Levels | Weeks 24-48 | To compare the change in CTX-1 levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls |
| Change in PTH Levels | Weeks 24-48 | To compare the change in PTH levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls |
| Change in 25-OH Vitamin D3 Levels | Weeks 24-48 | To compare the change in 25-OH vitamin D3 levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls |
Countries
United States
Participant flow
Recruitment details
Participants in the parent trial (CCTG 595) were offered the opportunity to enroll in this sub-study providing Vitamin D supplementation to HIV pre-exposure prophylaxis (PrEP).
Pre-assignment details
48 enrolled, 48 matched from parent study. Total 96 evaluated participants.
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D Supplement + PrEP Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks in addition to their PrEP provided through the main study. | 48 |
| PrEP Only Matched Group A cohort of main-study participants will be selected to match subjects enrolled in the sub-study to serve as controls for comparison. | 48 |
| Total | 96 |
Baseline characteristics
| Characteristic | Vitamin D Supplement + PrEP | PrEP Only Matched Group | Total |
|---|---|---|---|
| Age, Continuous | 33.5 years | 33.0 years | 33.2 years |
| Race/Ethnicity, Customized Asian | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Black | 13 Participants | 14 Participants | 27 Participants |
| Race/Ethnicity, Customized Hispanic | 16 Participants | 8 Participants | 24 Participants |
| Race/Ethnicity, Customized Multiracial | 6 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 26 Participants | 25 Participants | 51 Participants |
| Region of Enrollment United States | 48 participants | 48 participants | 96 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 48 Participants | 48 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
Primary
Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels
To compare the change in P1NP levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls
Time frame: Weeks 24-48
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D Supplement + PrEP | Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels | -27.6 pg/mL | Standard Deviation 49.9 |
| PrEP Only Matched Group | Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels | -2.5 pg/mL | Standard Deviation 40.2 |
Secondary
Change in 25-OH Vitamin D3 Levels
To compare the change in 25-OH vitamin D3 levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls
Time frame: Weeks 24-48
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D Supplement + PrEP | Change in 25-OH Vitamin D3 Levels | 4.4 ng/mL | Standard Deviation 16.2 |
| PrEP Only Matched Group | Change in 25-OH Vitamin D3 Levels | -0.9 ng/mL | Standard Deviation 13.7 |
Secondary
Change in CTX-1 Levels
To compare the change in CTX-1 levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls
Time frame: Weeks 24-48
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D Supplement + PrEP | Change in CTX-1 Levels | 0.03 ng/mL | Standard Deviation 1.12 |
| PrEP Only Matched Group | Change in CTX-1 Levels | 0.29 ng/mL | Standard Deviation 2.1 |
Secondary
Change in PTH Levels
To compare the change in PTH levels from Week 24 through Week 48 among subjects (cases) who receive vitamin D 4000 IU/day to the change in levels seen in matched unsupplemented controls
Time frame: Weeks 24-48
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D Supplement + PrEP | Change in PTH Levels | 57.3 pg/mL | Standard Deviation 128.9 |
| PrEP Only Matched Group | Change in PTH Levels | 108.4 pg/mL | Standard Deviation 210.5 |