Patient AdherencePhase 4CCTG595VitDNCT02367599
Effect of Vitamin D Supplementation on Bone Turnover Markers During PrEP in MSM
A Phase 4 study testing Vitamin D Supplement in people with Patient Adherence, run by University of California, San Diego at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Patient Adherence
- What is being tested?
- Vitamin D Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Dec 2014to 11 Jul 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects must meet CCTG 595 inclusion criteria.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Southern California
Los Angeles, California, 90033
University of California, San Diego
San Diego, California, 92103
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
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
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.
Read the 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).
- Conditions
- Patient Adherence
- Being tested
- Vitamin D Supplement
- Keywords
- PrEP, Pre exposure Prophylaxis, Truvada, CCTG, 595, Vitamin D, Bone mineral density
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D SupplementDrug
Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vitamin D Supplement |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Weeks 24-48
Secondary outcomes (3)
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
Measured: Weeks 24-48
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
Measured: 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
Measured: Weeks 24-48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study start15 Dec 2014
- Primary completion13 Jun 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patient AdherenceStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Sheldon Morris, University of California, San Diego
- Investigators
- Michael P Dube, MD, Study chair, CCTG, USCSheldon Morris, MD, Principal investigator, UC San Diego AntiViral Research Center (AVRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367599
- Sponsor's protocol ID
- CCTG 595 Vitamin D Sub-Study
- Acronym
- CCTG595VitD
- Status last verified
- Jun 2020
- First submitted
- 10 Feb 2015
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02367599
- Acronym / sponsor ID
- CCTG595VitD / CCTG 595 Vitamin D Sub-Study
- Conditions
- Patient Adherence
- Keywords
- PrEP, Pre exposure Prophylaxis, Truvada, CCTG, 595, Vitamin D, Bone mineral density
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- 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
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Posted 2 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Supplement + PrEP | Active comparator | Drug: Vitamin D SupplementSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects must meet CCTG 595 inclusion criteria.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D SupplementSubjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks. | Drug | Vitamin D Supplement + PrEP |
Primary outcome
Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels
Time frame: 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
3 secondary outcomes
Change in CTX-1 Levels
Time frame: Weeks 24-48
Change in PTH Levels
Time frame: Weeks 24-48
Change in 25-OH Vitamin D3 Levels
Time frame: Weeks 24-48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Dube, MD study chair
CCTG, USC
Sheldon Morris, MD principal investigator
UC San Diego AntiViral Research Center (AVRC)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D Supplement in people with Patient Adherence, run by University of California, San Diego at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Procollagen Type 1 N-terminal Propeptide (a Marker of Bone Formation) [P1NP] Levels (time frame: Weeks 24-48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.