Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IIS RFA _Asmuth:TMC114HIV2029 | Other Identifier | Other |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation (CD)4+ T-cell populations, normalization of systemic immune activation, and improved HIV-associated cardiovascular disease (CVD) risk.
Rationale Infection with HIV causes significant morbidity and mortality, even among individuals who are virologically suppressed with combination anti-retroviral therapy (ART). ART is effective in prolonging life and enabling individuals who are HIV positive to live near-normal life spans. However, these individuals are increasingly developing a number of chronic diseases of aging, such as atherosclerotic cardiovascular disease (ASCVD). The proposed studies will examine the role of highly active antiretroviral therapy in restoring the mucosal immunity and the systemic effect on immune activation, bacterial translocation, and change in HIV-associated cardiovascular disease risk.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV positive naive to ART | Active Comparator | HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART. |
|
| normal control volunteers | No Intervention | HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| darunavir with ritonavir and fixed-dose viread+emtricitabine daily | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV | CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV. | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage of Total Artery Diameter | computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systemic Immune Activation | Change in systemic immune activation, as measured by change in plasma cytokine levels (IL-6). | Baseline, 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis | Sacramento | California | 95617 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | HIV Positive Naive to ART | HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART. darunavir with ritonavir and fixed-dose viread+emtricitabine daily |
| FG001 | Normal Control Volunteers | HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HIV Positive Naive to ART | HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART. darunavir with ritonavir and fixed-dose viread+emtricitabine daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV | CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV. | HIV negative participants underwent the procedures only once at Screening (entry). In the HIV group the comparison between before and after ART was done using a Wilcoxon signed-rank test. | Posted | Median | Inter-Quartile Range | cells / mm^2 | Baseline, 12 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HIV Positive Naive to ART | HIV subjects will receive open-label darunavir 800 mg in combination with ritonavir 100 mg tablets and fixed-dose combination viread + emtricitabine (Truvada®) to be taken once daily without regard to food. Subjects will undergo upper endoscopy, CT cardiac angiogram, intimal-medial thickening, and peripheral blood collection before and after 12 months of ART. darunavir with ritonavir and fixed-dose viread+emtricitabine daily |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Asmuth, Professor of Medicine | University of California, Davis Health, Department of Internal Medicine | 916-734-8695 | dasmuth@UCDAVIS.EDU |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG001 | Normal Control Volunteers | HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CD4+ T-cells | Median | Inter-Quartile Range | cells/mm^3 |
|
| HIV viral load | Median | Inter-Quartile Range | copies/ml |
|
| weight | Median | Inter-Quartile Range | lbs |
|
| OG001 | Normal Control Volunteers | HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months. |
|
|
|
| Secondary | Change in Percentage of Total Artery Diameter | computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy | We compare wall thickness between HIV+ infected individuals and in the HIV group before and after 12-months of ART. | Posted | Median | Inter-Quartile Range | % of total artery diameter | Baseline, 12 months |
|
|
|
|
| Other Pre-specified | Change in Systemic Immune Activation | Change in systemic immune activation, as measured by change in plasma cytokine levels (IL-6). | Posted | Median | Inter-Quartile Range | pg/ml | Baseline, 12 months |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Normal Control Volunteers | HIV negative age-matched controls will undergo the same interventions and procedures without receiving ART at study entry and after 12 months. | 0 | 17 | 0 | 17 |
Not provided
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| 0.826 |
| Other |
Wilcoxon signed-rank test |
| Sign test |
| 0.807 |
| Other |