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| ID | Type | Description | Link |
|---|---|---|---|
| N/A (Parent P30AI028697) | Other Grant/Funding Number | UCLA AIDS Institute/Center for AIDS Research | |
| N/A (Parent UL1TR000124) | Other Grant/Funding Number | UCLA Clinical and Translational Science Institute | |
| 52767 | Other Grant/Funding Number | Merck Investigator Studies Program |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (HIV/HCV coinfected) | |||
| Group B (HIV monoinfected) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163) | Serum hsCRP | 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) |
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Inclusion Criteria
Exclusion Criteria
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HIV/HCV coinfected and HIV monoinfected adults with well-controlled HIV
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| Name | Affiliation | Role |
|---|---|---|
| Kara W. Chew, M.D., M.S. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA CARE Center | Los Angeles | California | 90025 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (HIV/HCV Coinfected) | HIV+, HCV viremic at study entry |
| FG001 | Group B (HIV Monoinfected) | HIV+, HCV negative at study entry |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (HIV/HCV Coinfected) | HIV+, HCV viremic at study entry |
| BG001 | Group B (HIV Monoinfected) | HIV+, HCV negative at study entry |
| 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 | 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) | Posted | Median | Inter-Quartile Range | ratio | Baseline |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | Group A (HIV/HCV Coinfected) | HIV+, HCV viremic at study entry | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kara Chew, MD, MS | David Geffen School of Medicine at UCLA | 310-825-0796 | kchew@mednet.ucla.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 | Mar 22, 2015 | Jan 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D008659 | Metabolic Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Plasma and serum
| Week 52 |
| Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163) | Serum hsCRP | Week 52 |
| Insulin Resistance by HOMA-IR | fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405 | Baseline |
| Insulin Resistance by HOMA-IR | fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405 | 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. | 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. | Week 52 |
| Change in RHI | 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 | Baseline to Week 52 |
| Change in HOMA-IR | 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. | Baseline to Week 52 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body mass index (kg/m2) | Median | Inter-Quartile Range | kg/m2 |
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| Hypertension | Count of Participants | Participants |
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| Dyslipidemia | Count of Participants | Participants |
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| CD4+ T cell count | Median | Inter-Quartile Range | cells/mm3 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163) | Serum hsCRP | All participants with available data. | Posted | Median | Inter-Quartile Range | mg/L | Baseline |
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | ratio | Week 52 |
|
|
|
| Secondary | Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163) | Serum hsCRP | All participants with available data. | Posted | Median | Inter-Quartile Range | mg/L | Week 52 |
|
|
|
| Secondary | Insulin Resistance by HOMA-IR | fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405 | All participants with available data. | Posted | Median | Inter-Quartile Range | HOMA-IR score | Baseline |
|
|
|
| Secondary | Insulin Resistance by HOMA-IR | fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405 | All participants with available data | Posted | Median | Inter-Quartile Range | HOMA-IR score | Week 52 |
|
|
|
| Secondary | 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. | All participants with available data | Posted | Median | Inter-Quartile Range | percent, 10-year risk | Baseline |
|
|
|
| Secondary | 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. | All participants with available data | Posted | Median | Inter-Quartile Range | percent, 10-year risk | Week 52 |
|
|
|
| Secondary | Change in RHI | All with available data | Posted | Median | Inter-Quartile Range | ratio | Baseline to Week 52 |
|
|
|
| Secondary | 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 | All participants with available data | Posted | Median | Inter-Quartile Range | mg/L | Baseline to Week 52 |
|
|
|
| Secondary | Change in HOMA-IR | All participants with available data | Posted | Median | Inter-Quartile Range | HOMA-IR score | Baseline to Week 52 |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | percent | Baseline to Week 52 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group B (HIV Monoinfected) | HIV+, HCV negative at study entry | 0 | 0 | 0 | 0 | 0 | 0 |
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |