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| Name | Class |
|---|---|
| amfAR, The Foundation for AIDS Research | OTHER |
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The investigators propose a proof-of-concept, pathogenesis-oriented, randomized, placebo-controlled pilot study to assess whether the addition of an angiotensin converting enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune responses and an accelerated clearance of the latent reservoir.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACE Inhibitor | Active Comparator | Active group |
|
| Placebo | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisinopril | Drug | Lisinopril 20mg QD x 24 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HIV RNA (Copies/Million Rectal Cells) | Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline | 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HIV DNA (Copies/Million Rectal Cells) | Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline | 22 weeks |
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Inclusion Criteria include:
Exclusion Criteria include:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroyu Hatano, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94110 | United States |
The trial over enrolled by one individual as one participant discontinued the study after enrollment due to an adverse event.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACE Inhibitor | Active group Lisinopril: Lisinopril 20mg QD x 24 weeks |
| FG001 | Placebo | Placebo group Placebo: Placebo QD x24wks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACE Inhibitor | Active group Lisinopril: Lisinopril 20mg Daily x 24 weeks |
| BG001 | Placebo | Placebo group Placebo: Placebo Daily x24wks |
| 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 | Change in HIV RNA (Copies/Million Rectal Cells) | Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline | Three participants in the placebo group did not have sufficient cells for analysis for one of the time points. | Posted | Median | Inter-Quartile Range | copies/million rectal cells | 22 weeks |
|
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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 | ACE Inhibitor | Active group Lisinopril: Lisinopril 20mg QD x 24 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevation in serum creatinine | Renal and urinary disorders | One subject had elevation of serum creatinine and was withdrawn from the study at Week 12 for this. However, labs drawn at that time showed that the serum creatinine had returned to baseline and was likely secondary to another medical condition. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leslie Cockerham | Medical College of Wisconsin | 414-805-0738 | lcockerham@mcw.edu |
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| ID | Term |
|---|---|
| D017706 | Lisinopril |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Drug |
Placebo QD x24wks |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| CD4+ T cell count | Median | Inter-Quartile Range | cells/mm^3 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Change in HIV DNA (Copies/Million Rectal Cells) | Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline | Three participants in the placebo group did not have sufficient cells for analysis for one of the time points. | Posted | Median | Inter-Quartile Range | copies/million rectal cells | 22 weeks |
|
|
|
|
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | Placebo | Placebo group Placebo: Placebo QD x24wks | 0 | 15 | 0 | 15 |
|
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