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| Name | Class |
|---|---|
| University of Southern California | OTHER |
| University of California, Los Angeles | OTHER |
| City of Long Beach Department of Health and Human Services | OTHER_GOV |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D Supplement + PrEP | Active Comparator | 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. |
|
| PrEP Only | No Intervention | Subjects not enrolled into this sub-study will continue receiving PrEP through the main study. Subjects taking unsupplemented PrEP may still be used as matched controls to sub-study subjects. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D Supplement | Drug | Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Weeks 24-48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Weeks 24-48 |
| Change in PTH Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Dube, MD | CCTG, USC | Study Chair |
| Sheldon Morris, MD | UC San Diego AntiViral Research Center (AVRC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Southern California | Los Angeles | California | 90033 | United States | ||
| University of California, San Diego |
48 enrolled, 48 matched from parent study. Total 96 evaluated participants.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 parent trial. |
| FG001 | PrEP Only Matched Group | A cohort of parent trial participants will be selected to match subjects enrolled in the sub-study to serve as comparative controls. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | PrEP Only Matched Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | pg/mL | Weeks 24-48 |
|
Weeks 24-48
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheldon Morris | UCSD | 6195438080 | shmorris@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2015 | Jun 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| California HIV/AIDS Research Program |
| OTHER |
| Gilead Sciences | INDUSTRY |
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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
| Weeks 24-48 |
| 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 | Weeks 24-48 |
| San Diego |
| California |
| 92103 |
| United States |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
A cohort of main-study participants will be selected to match subjects enrolled in the sub-study to serve as controls for comparison.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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 | Posted | Mean | Standard Deviation | ng/mL | Weeks 24-48 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | pg/mL | Weeks 24-48 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | ng/mL | Weeks 24-48 |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | 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. | 0 | 48 | 0 | 48 | 0 | 48 |
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