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| ID | Type | Description | Link |
|---|---|---|---|
| 13-3613 | Other Identifier | Hennepin County Medical Center | |
| U01AI105872 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Merck Sharp & Dohme LLC | INDUSTRY |
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This study was designed to test the hypothesis that treatment of HIV infected subjects with losartan, an agent with specific anti-inflammatory and anti-fibrotic actions, will:
This is a randomized, double-blind, placebo-controlled trial of 50 HIV-1 infected individuals on stable ART randomized in a 1:1 ratio to losartan (50 mg orally daily titrated to 100 mg daily) vs placebo for 30 months. We plan to enroll a total of 63 HIV infected subjects to ensure that 50 complete the protocol. All HIV infected subjects will undergo biopsies of inguinal lymph node (LN) and gut associated lymphatic tissue (GALT) for primary endpoint analysis at baseline, 12 and 30 months after study enrollment. Blood will be collected at least quarterly throughout the study and an intensive blood pharmacokinetic (PK) study will be conducted at month 1. All HIV infected subjects will be vaccinated with the quadrivalent human papillomavirus (HPV) vaccine at months 23, 25 and 29.5 to measure immune function. 5 HIV uninfected control subjects will also be enrolled.
The primary endpoint is to determine the impact of losartan on lymphoid tissue fibrosis in HIV infected, ART treated adults. This will be determined by measuring the amount of collagen deposition in lymphoid tissues and the integrity of the FRCn using immunohistochemistry (IHC) and quantitative image analysis (QIA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan | Experimental |
| |
| Sugar Pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan | Drug | Participants will start with 50 mg of losartan by mouth daily. The dose will be increased to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Collagen Deposition in LT | The Impact of Losartan Treatment on Lymphoid Tissue (LT) Fibrosis will be determined by measuring the amount of collagen deposition in LT using immunohistochemistry (IHC) and quantitative image analysis (QIA). LT will be obtained at baseline, month 12 and month 30. | 30 months |
| Integrity of the Fibroblastic Reticular Cell Network (FRCn) | The Impact of Losartan Treatment on Lymphoid Tissue (LT) Fibrosis will be determined by measuring the Integrity of the fibroblastic reticular cell network (FRCn) using immunohistochemistry (IHC) and quantitative image analysis (QIA). LT will be obtained at baseline, month 12 and month 30. | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of CD4+ T Cells | Impact of losartan on immune reconstitution and function will be determined by frequency of CD4+ T cells in LT using IHC. | 30 months |
| Frequency TUNEL+CD3+CD8+ T Cells |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Dendritic Cell and CD4 T Cell Interactions With the FRCn | As an exploratory endpoint, we will determine the impact of losartan on frequency of dendritic cell and CD4 T cell interactions with the FRCn. This will be determined using two-photon microscopy in sections on LN obtained from study subjects. Given that this is an exploratory endpoint, these assays will be performed in a subset of subjects (5 losartan treated, 2 placebo treated and 5 HIV uninfected controls). |
HIV infected participants:
Inclusion Criteria:
Participants must meet all of the following inclusion criteria to participate in this study:
HIV-1 infected.
-≥ 18 years of age.
Baseline peripheral CD4+ T cell count 200-600 cells/mm3 for at least two measures over the 6 months prior to study enrollment.
-≥ 12 months of stable ART, defined as use of a given drug regimen without disruption lasting ≥ 1 week in the period leading up to study enrollment.
HIV viral load (VL) < 50 copies/mL for at least two consecutive measures over the 6 months prior to study enrollment.
No contraindication to proposed study procedures.
Women of child-bearing potential must be willing to use a form of effective contraception for the duration of the study. Effective contraception includes hormonal injection, implant or oral medication, IUD, diaphragm, or cervical cap with spermicide. Condoms cannot be used as the sole form of contraception.
Exclusion Criteria: Participants meeting any of the following exclusion criteria at baseline will be excluded from study participation:
HIV-uninfected:
Inclusion Criteria
Participants must meet all of the following inclusion criteria to participate in this study:
HIV uninfected.
-≥ 18 years of age.
No contraindication to proposed study procedures.
Exclusion Criteria: Participants meeting any of the following exclusion criteria at baseline will be excluded from study participation:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Schacker, M.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota, Division of Infectious Diseases | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan | Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months. |
| FG001 | Sugar Pill | Placebo: one tablet by mouth daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan | Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months. |
| BG001 | Sugar Pill |
| 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 | Collagen Deposition in LT | The Impact of Losartan Treatment on Lymphoid Tissue (LT) Fibrosis will be determined by measuring the amount of collagen deposition in LT using immunohistochemistry (IHC) and quantitative image analysis (QIA). LT will be obtained at baseline, month 12 and month 30. | Some participant data was left out of this analysis due to sample quality. | Posted | Mean | Standard Deviation | percent area | 30 months |
|
30 months
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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 | Losartan | Losartan: We will start with 50 mg of losartan by mouth daily. We will increase the dosage to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Chemotherapy | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Schacker, MD | University of Minnesota | 612-626-6577 | olso7966@umn.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 1, 2017 | Jul 16, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 26, 2018 | Jul 16, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D007239 | Infections |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Placebo | Drug | one tablet by mouth daily |
|
Impact of losartan on immune reconstitution and function will be determined by frequency of TUNEL+CD3+CD8+ T cells in LT using IHC.
| 30 months |
| Frequency of Cells Expressing TGF-beta and Lymphotoxin-beta | Impact of losartan on immune reconstitution and function will be determined by frequency of cells expressing TGF-beta and lymphotoxin-beta in LT using IHC. | 30 months |
| Serum Concentration of IL-7 | Impact of losartan on immune reconstitution and function will be determine by serum concentrations of IL-7 measured with ELISA. | 30 months |
| Serum Concentration of TGF-beta | Impact of losartan on immune reconstitution and function will be determine by serum concentrations of TGF-beta measured with ELISA. | 30 months |
| Immune Response to HPV Vaccination | Impact of losartan on immune reconstitution and function will be determine by measuring the immune response to HPV vaccination using flow cytometry to identify cells stimulated by specific HPV peptides. | 30 months |
| Frequency of Activated T-cell Populations - Immunofluorescent Staining | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the frequency of activated T-cell populations (specifically CD3+CD4+CD38+, CD3+,CD8+CD38+,CD4+Ki67+ and CD8+Ki67+ T cells) in LT using immunofluorescence staining | 30 months |
| Percent of Activated T Cells in PBMCs - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated T cells in peripheral blood mononuclear cells (PBMCs) using flow cytometry. | 30 months |
| Percent of Activated Macrophages in PBMCs - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated macrophages in peripheral blood mononuclear cells (PBMCs) using flow cytometry. | 30 months |
| Percent of Activated Dendritic Cells in PBMCs - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated dendritic cells in peripheral blood mononuclear cells (PBMCs) using flow cytometry. | 30 months |
| Percent of Activated T Cells in LT - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated T cells in lymphoid tissues (LT) using flow cytometry. | 30 months |
| Percent of Activated Macrophages in LT - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated macrophages in lymphoid tissues (LT) using flow cytometry. | 30 months |
| Percent of Activated Dendritic Cells in LT - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated dendritic cells in lymphoid tissues (LT) using flow cytometry. | 30 months |
| Intracellular Concentration of IL-17 in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-17 in PBMCs using cytokine staining. | 30 months |
| Intracellular Concentration of IFNg in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IFNg in PBMCs using cytokine staining. | 30 months |
| Intracellular Concentration of IL-2 in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-2 in PBMCs using cytokine staining. | 30 months |
| Intracellular Concentration of TNF in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine TNF in PBMCs using cytokine staining. | 30 months |
| Intracellular Concentration of IL-10 in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-10 in PBMCs using cytokine staining. | 30 months |
| Intracellular Concentration of GM-CSF in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine GM-CSF in PBMCs using cytokine staining. | 30 months |
| Intracellular Concentration of IL-17 in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-17 in lymphoid tissue (LT) using cytokine staining. | 30 months |
| Intracellular Concentration of IFNg in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IFNg in lymphoid tissue (LT) using cytokine staining. | 30 months |
| Intracellular Concentration of IL-2 in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-2 in lymphoid tissue (LT) using cytokine staining. | 30 months |
| Intracellular Concentration of TNF in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine TNF in lymphoid tissue (LT) using cytokine staining. | 30 months |
| Intracellular Concentration of IL-10 in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-10 in lymphoid tissue (LT) using cytokine staining. | 30 months |
| Intracellular Concentration of GM-CSF in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine GM-CSF in lymphoid tissue (LT) using cytokine staining. | 30 months |
| Plasma Concentration of LPS | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of LPS by ELISA. | 30 months |
| Plasma Concentration of sCD14 | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of sCD14 by limulus assay. | 30 months |
| Plasma Concentration of I-FABP | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of I-FABP using ELISA. | 30 months |
| Plasma Concentration of IL-1b | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of IL-1b using ELISA. | 30 months |
| Plasma Concentration of IL-1RA | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of IL-1RA using ELISA. | 30 months |
| Plasma Concentration of IL-6 | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of IL-6 using ELISA. | 30 months |
| Plasma Concentration of TNF | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of TNF using ELISA. | 30 months |
| Plasma Concentration of Amyloid A | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of amyloid A using ELISA. | 30 months |
| Plasma Concentration of CRP | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of CRP using ELISA. | 30 months |
| Plasma Concentration of D-dimer | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of D-dimer using ELISA. | 30 months |
| Frequency of HIV RNA+ and DNA+ Cells in LN - Radiolabeled ISH | The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in LN using radiolabeled in situ hybridization (ISH). | 30 months |
| Frequency of HIV RNA+ and DNA+ Cells in LN - RNAscopeTM in Situ Technology | The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in LN using RNAscopeTM in situ technology. | 30 months |
| Frequency of HIV RNA+ and DNA+ Cells in GALT - Radiolabeled in Situ Hybridization (ISH) | The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in GALT radiolabeled in situ hybridization (ISH). | 30 months |
| Frequency of HIV RNA+ and DNA+ Cells in GALT - RNAscopeTM in Situ Technology | The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in GALT using RNAscopeTM in situ technology. | 30 months |
| Concentration of Losartan and Antiretrovirals (ARVs) | Potential Drug-drug Interactions Between Losartan and Antiretrovirals (ARVs) will be assessed by measuring levels of ARVs and losartan in plasma and peripheral blood mononuclear cells (PBMCs). | 30 months |
| Intracellular Concentration of Losartan and Antiretrovirals (ARVs) | Potential Drug-drug Interactions Between Losartan and Antiretrovirals (ARVs) will be assessed by measuring intracellular concentration of losartan and ARVs in lympoidtissue. | 30 months |
| 30 months |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
Placebo: one tablet by mouth daily |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo: one tablet by mouth daily |
|
|
| Primary | Integrity of the Fibroblastic Reticular Cell Network (FRCn) | The Impact of Losartan Treatment on Lymphoid Tissue (LT) Fibrosis will be determined by measuring the Integrity of the fibroblastic reticular cell network (FRCn) using immunohistochemistry (IHC) and quantitative image analysis (QIA). LT will be obtained at baseline, month 12 and month 30. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Frequency of CD4+ T Cells | Impact of losartan on immune reconstitution and function will be determined by frequency of CD4+ T cells in LT using IHC. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Frequency TUNEL+CD3+CD8+ T Cells | Impact of losartan on immune reconstitution and function will be determined by frequency of TUNEL+CD3+CD8+ T cells in LT using IHC. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Frequency of Cells Expressing TGF-beta and Lymphotoxin-beta | Impact of losartan on immune reconstitution and function will be determined by frequency of cells expressing TGF-beta and lymphotoxin-beta in LT using IHC. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Serum Concentration of IL-7 | Impact of losartan on immune reconstitution and function will be determine by serum concentrations of IL-7 measured with ELISA. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Serum Concentration of TGF-beta | Impact of losartan on immune reconstitution and function will be determine by serum concentrations of TGF-beta measured with ELISA. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Immune Response to HPV Vaccination | Impact of losartan on immune reconstitution and function will be determine by measuring the immune response to HPV vaccination using flow cytometry to identify cells stimulated by specific HPV peptides. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Frequency of Activated T-cell Populations - Immunofluorescent Staining | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the frequency of activated T-cell populations (specifically CD3+CD4+CD38+, CD3+,CD8+CD38+,CD4+Ki67+ and CD8+Ki67+ T cells) in LT using immunofluorescence staining | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Percent of Activated T Cells in PBMCs - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated T cells in peripheral blood mononuclear cells (PBMCs) using flow cytometry. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Percent of Activated Macrophages in PBMCs - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated macrophages in peripheral blood mononuclear cells (PBMCs) using flow cytometry. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Percent of Activated Dendritic Cells in PBMCs - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated dendritic cells in peripheral blood mononuclear cells (PBMCs) using flow cytometry. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Percent of Activated T Cells in LT - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated T cells in lymphoid tissues (LT) using flow cytometry. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Percent of Activated Macrophages in LT - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated macrophages in lymphoid tissues (LT) using flow cytometry. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Percent of Activated Dendritic Cells in LT - Flow Cytometry | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the percentage of activated dendritic cells in lymphoid tissues (LT) using flow cytometry. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of IL-17 in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-17 in PBMCs using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of IFNg in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IFNg in PBMCs using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of IL-2 in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-2 in PBMCs using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of TNF in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine TNF in PBMCs using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of IL-10 in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-10 in PBMCs using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of GM-CSF in PBMCs | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine GM-CSF in PBMCs using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of IL-17 in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-17 in lymphoid tissue (LT) using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of IFNg in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IFNg in lymphoid tissue (LT) using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of IL-2 in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-2 in lymphoid tissue (LT) using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of TNF in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine TNF in lymphoid tissue (LT) using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of IL-10 in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine IL-10 in lymphoid tissue (LT) using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of GM-CSF in LT | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the intracellular levels of the inflammatory cytokine GM-CSF in lymphoid tissue (LT) using cytokine staining. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Plasma Concentration of LPS | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of LPS by ELISA. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Plasma Concentration of sCD14 | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of sCD14 by limulus assay. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Plasma Concentration of I-FABP | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of I-FABP using ELISA. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Plasma Concentration of IL-1b | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of IL-1b using ELISA. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Plasma Concentration of IL-1RA | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of IL-1RA using ELISA. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Plasma Concentration of IL-6 | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of IL-6 using ELISA. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Plasma Concentration of TNF | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of TNF using ELISA. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Plasma Concentration of Amyloid A | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of amyloid A using ELISA. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Plasma Concentration of CRP | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of CRP using ELISA. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Plasma Concentration of D-dimer | The Impact of Losartan on Immune Activation in HIV Infected, Treated Individuals will be determined by measuring the plasma concentration of D-dimer using ELISA. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Frequency of HIV RNA+ and DNA+ Cells in LN - Radiolabeled ISH | The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in LN using radiolabeled in situ hybridization (ISH). | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Frequency of HIV RNA+ and DNA+ Cells in LN - RNAscopeTM in Situ Technology | The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in LN using RNAscopeTM in situ technology. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Frequency of HIV RNA+ and DNA+ Cells in GALT - Radiolabeled in Situ Hybridization (ISH) | The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in GALT radiolabeled in situ hybridization (ISH). | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Frequency of HIV RNA+ and DNA+ Cells in GALT - RNAscopeTM in Situ Technology | The Potential for Losartan to Reduce the Size of the Viral Reservoir will be assessed by determining the frequency of HIV RNA+ and DNA+ cells in GALT using RNAscopeTM in situ technology. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Concentration of Losartan and Antiretrovirals (ARVs) | Potential Drug-drug Interactions Between Losartan and Antiretrovirals (ARVs) will be assessed by measuring levels of ARVs and losartan in plasma and peripheral blood mononuclear cells (PBMCs). | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Secondary | Intracellular Concentration of Losartan and Antiretrovirals (ARVs) | Potential Drug-drug Interactions Between Losartan and Antiretrovirals (ARVs) will be assessed by measuring intracellular concentration of losartan and ARVs in lympoidtissue. | This measure was planned at the time of registration, however it was not collected during the course of the trial. This data is not able to be reported. | Posted | 30 months |
|
|
| Other Pre-specified | Frequency of Dendritic Cell and CD4 T Cell Interactions With the FRCn | As an exploratory endpoint, we will determine the impact of losartan on frequency of dendritic cell and CD4 T cell interactions with the FRCn. This will be determined using two-photon microscopy in sections on LN obtained from study subjects. Given that this is an exploratory endpoint, these assays will be performed in a subset of subjects (5 losartan treated, 2 placebo treated and 5 HIV uninfected controls). | This exploratory endpoint was not analyzed and data are not available to be reported. | Posted | 30 months |
|
|
| 1 |
| 25 |
| 2 |
| 25 |
| 25 |
| 25 |
| EG001 | Sugar Pill | Placebo: one tablet by mouth daily | 1 | 27 | 6 | 27 | 27 | 27 |
| Hospitalization for Illness | General disorders | Systematic Assessment |
|
| Hospitalization for Surgery | General disorders | Systematic Assessment |
|
| Unintentional Weight Loss | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Orthopedic injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neuro-syphillis diagnosis | Infections and infestations | Systematic Assessment |
|
| Eye watering | Eye disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Arm pain/numbness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cold/flu symptoms | General disorders | Systematic Assessment |
|
| Toothache | General disorders | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Cellulitis | General disorders | Systematic Assessment |
|
| Light-headedness | General disorders | Systematic Assessment |
|
| Pustular node | General disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Jock itch | General disorders | Systematic Assessment |
|
| Sciatica, worsened | General disorders | Systematic Assessment |
|
| Neuropathy, worsened | Nervous system disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Infected scatch | Infections and infestations | Systematic Assessment |
|
| Gas, belching | Gastrointestinal disorders | Systematic Assessment |
|
| Food poisoning | Infections and infestations | Systematic Assessment |
|
| Brain aneurysm | Vascular disorders | Systematic Assessment |
|
| Pain/swelling at incision site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Elevated blood glucose | Metabolism and nutrition disorders | Systematic Assessment |
|
| Sinus infection | Infections and infestations | Systematic Assessment |
|
| Restless leg syndrome diagnoses | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Mild sleep apnea | General disorders | Systematic Assessment |
|
| Shingles | Infections and infestations | Systematic Assessment |
|
| Liver cirrhosis | Hepatobiliary disorders | Systematic Assessment |
|
| Fatigue/sluggishness | General disorders | Systematic Assessment |
|
| "Tight" feeling in nose and throat | General disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dry eyes | Eye disorders | Systematic Assessment |
|
| Dry mouth/cotton mouth | General disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Benign prostate hypertrophy | General disorders | Systematic Assessment |
|
| Night sweats | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Abdominal pain | General disorders | Systematic Assessment |
|
| Kidney stones | Renal and urinary disorders | Systematic Assessment |
|
| Fainting episode | General disorders | Systematic Assessment |
|
| Blood in stool | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| High blood pressure | General disorders | Systematic Assessment |
|
| Hot water burn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bump at injection site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Red, swollen area at drug injection site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sinus pain/congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
|
| Skin abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sores on gums | General disorders | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pinched nerve | Nervous system disorders | Systematic Assessment |
|
| Flu vaccine reaction | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Unknown weight loss | General disorders | Systematic Assessment |
|
| Borborygmus | Gastrointestinal disorders | Systematic Assessment |
|
| Bloody nose | General disorders | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
|
| Vertigo | Nervous system disorders | Systematic Assessment |
|
| Numbness in hand | Nervous system disorders | Systematic Assessment |
|
| Heart burn | Gastrointestinal disorders | Systematic Assessment |
|
| Lyme disease | Infections and infestations | Systematic Assessment |
|
| Groin pain | General disorders | Systematic Assessment |
|
| Heart palpitations | Cardiac disorders | Systematic Assessment |
|
| Blastocis hominus | Infections and infestations | Systematic Assessment |
|
| Venous insufficiency | Vascular disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Itchy rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Elevated creatinine | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Foot callus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hand injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Increased acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Mood swings | Psychiatric disorders | Systematic Assessment |
|
| Bilateral foot pain | General disorders | Systematic Assessment |
|
| Microdiscectomy | Surgical and medical procedures | Systematic Assessment |
|
| Giardia | Infections and infestations | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Colon polyp | Gastrointestinal disorders | Systematic Assessment |
|
| Syphilis | Infections and infestations | Systematic Assessment |
|
| Temporal mandibular joint pain | General disorders | Systematic Assessment |
|
| Seasonal allergies | Immune system disorders | Systematic Assessment |
|
| Sleep disturbance | General disorders | Systematic Assessment |
|
| Rectal pain | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Increased viral load | Infections and infestations | Systematic Assessment |
|
| Excision of anal lesion | Surgical and medical procedures | Systematic Assessment |
|
| Multiple sclerosis flare-up | General disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cold sore | General disorders | Systematic Assessment |
|
| Basal cell carcinoma | General disorders | Systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Toe infection | Infections and infestations | Systematic Assessment |
|
| Loss of consciousness during blood draw | General disorders | Systematic Assessment |
|
| Conjuctivitis | Eye disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Low blood pressure | Blood and lymphatic system disorders | Systematic Assessment |
|
| Sore throat | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |