HIVCTSI-PLACENCT02597790
A Prospective, Longitudinal Study of Endothelial Function in HIV/HCV Coinfected Subjects
An observational study of HIV and Hepatitis C, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Hepatitis C
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2020
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV/HCV coinfected and HIV monoinfected adults with well-controlled HIV
Who may be able to join
- Men and women ≥ 18 years
- Hepatitis C negative or chronic hepatitis C infection
- Chronic HIV infection
- CD4+ T-cell count > 200 cells/mm3
- Plasma HIV-1 RNA < 50 copies/mL
- On continuous and stable ART for at least 12 weeks
- Ability and willingness to provide written informed consent.
Who cannot join
- Known cardiovascular disease
- Diabetes requiring insulin therapy or hemoglobin A1c > 8%
- Inability to conform to requirements for PAT testing
- Decompensated liver disease
- Other known causes of significant liver disease
- Serious illness including acute liver-related disease and malignancy requiring systemic treatment or hospitalization within 12 weeks prior to study entry
Show all 13Show fewer
- Presence of active or acute AIDS-defining opportunistic infections (OIs) within 12 weeks prior to study entry
- History of major organ transplantation with an existing functional graft and on immunosuppressive therapy
- History of known vascular or autoimmune disease
- Pregnancy
- HCV treatment (any approved or investigational agents) within 24 weeks prior to study entry
- Use of immune-based therapies or systemic corticosteroids within 12 weeks prior to study entry
- Advanced renal insufficiency as defined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 or treatment by dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Translational Science Institute Prospective Longitudinal Assessment of Coinfected Subjects With HIV/Hepatitis C for Endothelial Function Study
The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Participants will undergo non-invasive assessment of cardiovascular disease risk through measurements of endothelial function and blood biomarkers at baseline and 1 year (or 4 weeks and 24 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).
- Conditions
- HIV, Hepatitis C
- Keywords
- endothelial function, cardiovascular risk, HIV, Hepatitis C, metabolic disease, inflammation
- Medical subject headings
- Hepatitis C, Metabolic Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A (HIV/HCV coinfected) | Not described | |
| Group B (HIV monoinfected) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT)
Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)
Measured: Baseline
Secondary outcomes (11)
Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Serum hsCRP
Measured: Baseline
Reactive Hyperemia Index (RHI)
Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)
Measured: Week 52
Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Serum hsCRP
Measured: Week 52
Insulin Resistance by HOMA-IR
fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405
Measured: Baseline
Insulin Resistance by HOMA-IR
fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405
Measured: Week 52
Framingham Risk Score (FRS), 10-year Risk (%)
Estimate of 10-year risk for developing coronary heart disease (CHD), calculated as described in ATP III Executive Summary, JAMA, May 16, 2001-Vol 285, No. 19. Range of values is <1 to >/= 30% Higher risk % is worse predicted outcome.
Measured: Baseline
Framingham Risk Score (FRS), 10-year Risk (%)
Estimate of 10-year risk for developing coronary heart disease (CHD), calculated as described in ATP III Executive Summary, JAMA, May 16, 2001-Vol 285, No. 19. Range of values is <1 to >/= 30% Higher risk % is worse predicted outcome.
Measured: Week 52
Change in RHI
Measured: Baseline to Week 52
Change in Level of Each Soluble Biomarker (Components of Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Change in serum hsCRP level
Measured: Baseline to Week 52
Change in HOMA-IR
Measured: Baseline to Week 52
Change in Framingham Risk Score (10-year Risk, %)
Change in estimated 10-year risk (% risk) for developing coronary heart disease (CHD). Positive value indicates increase in estimated 10-year risk for CHD from baseline to Week 52. Negative value indicates decrease in estimated 10-year risk for CHD from baseline to Week 52.
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startOct 2013
- Primary completionJan 2019
- Study completionJan 2020
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 HIVStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Kara Chew, University of California, Los Angeles
- Investigators
- Kara W. Chew, M.D., M.S., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597790
- Sponsor's protocol ID
- 12-001792 (CTSI-PLACE)
- Other IDs
- N/A (Parent P30AI028697), N/A (Parent UL1TR000124), 52767
- Acronym
- CTSI-PLACE
- Status last verified
- Dec 2021
- First submitted
- 30 Oct 2015
- Last updated
- 20 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Translational Science Institute Prospective Longitudinal Assessment of Coinfected Subjects With HIV/Hepatitis C for Endothelial Function Study
- ClinicalTrials.gov ID
- NCT02597790
- Acronym / sponsor ID
- CTSI-PLACE / 12-001792 (CTSI-PLACE)
- Conditions
- HIV, Hepatitis C
- Keywords
- endothelial function, cardiovascular risk, HIV, Hepatitis C, metabolic disease, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Oct 2013
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Posted 20 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Participants will undergo non-invasive assessment of cardiovascular disease risk through measurements of endothelial function and blood biomarkers at baseline and 1 year (or 4 weeks and 24 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (HIV/HCV coinfected) | – | – |
| Group B (HIV monoinfected) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV/HCV coinfected and HIV monoinfected adults with well-controlled HIV
Key inclusion criteria (7 listed)
- Men and women ≥ 18 years
- Hepatitis C negative or chronic hepatitis C infection
- Chronic HIV infection
- CD4+ T-cell count > 200 cells/mm3
- Plasma HIV-1 RNA < 50 copies/mL
Key exclusion criteria (13 listed)
- Known cardiovascular disease
- Diabetes requiring insulin therapy or hemoglobin A1c > 8%
- Inability to conform to requirements for PAT testing
- Decompensated liver disease
- Other known causes of significant liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT)
Time frame: Baseline
Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)
11 secondary outcomes
Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Time frame: Baseline
Reactive Hyperemia Index (RHI)
Time frame: Week 52
Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Time frame: Week 52
Insulin Resistance by HOMA-IR
Time frame: Baseline
Insulin Resistance by HOMA-IR
Time frame: Week 52
Framingham Risk Score (FRS), 10-year Risk (%)
Time frame: Baseline
Framingham Risk Score (FRS), 10-year Risk (%)
Time frame: Week 52
Change in RHI
Time frame: Baseline to Week 52
Change in Level of Each Soluble Biomarker (Components of Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Time frame: Baseline to Week 52
Change in HOMA-IR
Time frame: Baseline to Week 52
Change in Framingham Risk Score (10-year Risk, %)
Time frame: Baseline to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- 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.
Kara W. Chew, M.D., M.S. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Hepatitis C, run by University of California, Los Angeles at 1 site 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 7 inclusion and 13 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 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2022). 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?
Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT) (time frame: Baseline). 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 20 Jan 2022.