HIV InfectionPhase 2NCT01852942
Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
A Phase 2 study testing Losartan in people with HIV Infection and HIV Infections, run by University of Minnesota at 1 site in United States.
Trial summary
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: 1. reverse existing lymphoid tissue fibrosis, 2. restore lymphoid tissue architecture, 3. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, HIV Infections
- What is being tested?
- Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 16 Jul 2019
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
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:
- Use of any immunomodulator within the 12 months prior to study enrollment. An immunomodulator for the purposes of this study is defined as a drug known to either diminish or augment a patient's immune system. Examples of these include, but are not limited to, systemic corticosteroids (use of topical steroids will be permitted), TNF-inhibitors, rituximab, cyclophosphamide, abatacept,cyclosporine, azathioprine, 6-mercaptopurine, methotrexate, sulfasalazine, cyclosporine, tacrolimus,sirolimus, and intravenous immune globulin.
- Current use of an ARB or ACEi.
- Current use of rifaximin, fluconazole or lithium given potential for drug interactions with losartan.
- Prior reaction or intolerance to an ARB or ACEi.
- Prior diagnosis of a chronic inflammatory disease with serologic or clinical evidence as diagnosed by a primary care physician or specialist. Examples of these include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren's syndrome, mixed connective tissue disease, psoriasis, polymyositis, dermatomyositis, vasculitis, sarcoidosis, Wegener's granulomatosis, giant cell arteritis, polyarteritis nodosa, gastrointestinal pemphigoid, eosinophilic colitis, Crohn's disease, ulcerative colitis, autoimmune hepatitis, and hepatitis C.
- Prior diagnosis of a connective tissue disease with genetic, serologic or clinical evidence as diagnosed by a primary care physician or specialist (Marfan's syndrome, Ehlers-Danlos syndrome).
- Baseline blood pressure < 110/70.
- Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 within 4 weeks of study initiation or history of advanced renal disease.
- AST and/or ALT > 3 times the upper limit of normal within 4 weeks of study enrollment.
- Potassium > 5.0 within 4 weeks of study enrollment.
- Pregnancy.
- In women of childbearing age, unwillingness to use birth control for the duration of the study.
- Breast feeding.
- Prior vaccination with an HPV vaccine, including Cervarix (GlaxoSmithKline) or Gardasil (Merck).
- History of hypersensitivity or severe allergic reactions to yeast.
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:
- Use of any immunomodulator within the 12 months prior to study enrollment (as defined above).
- Current use of an ARB or ACEi.
- Prior diagnosis of a chronic inflammatory disease with serologic or clinical evidence (as defined above).
- Prior diagnosis of a connective tissue disease with genetic, serologic or clinical evidence as diagnosed by a primary care physician or specialist (Marfan's syndrome, Ehlers-Danlos syndrome).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Division of Infectious Diseases
Minneapolis, Minnesota, 55455
About this study
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:
- reverse existing lymphoid tissue fibrosis,
- restore lymphoid tissue architecture,
- increase the number and improve the function of peripheral and lymphatic CD4 T cells,
- decrease levels of systemic immune activation (IA),
- decrease size of the HIV reservoir, and
- be safe and well tolerated.
Read the detailed description
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).
- Conditions
- HIV Infection, HIV Infections
- Being tested
- Losartan, Placebo
- Keywords
- Infection, HIV 1, HIV, Losartan, Fibrosis, Immune Activation, Immune Reconstitution
- Medical subject headings
- HIV Infections, Infections, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
Also called Cozaar
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.
PlaceboDrug
one tablet by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Experimental | Not described Receives: Drug: Losartan |
| Sugar Pill | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 months
Secondary outcomes (41)
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.
Measured: 30 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startSep 2014
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
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 HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Schacker, M.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852942
- Sponsor's protocol ID
- 1111M06585
- Other IDs
- 13-3613, U01AI105872
- Status last verified
- Nov 2020
- First submitted
- 20 Feb 2012
- Last updated
- 11 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV
- ClinicalTrials.gov ID
- NCT01852942
- Acronym / sponsor ID
- 1111M06585
- Conditions
- HIV Infection, HIV Infections
- Keywords
- Infection, HIV 1, HIV, Losartan, Fibrosis, Immune Activation, Immune Reconstitution
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Merck Sharp & Dohme LLC
- Study start
- Sep 2014 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 14 May 2013 (estimated)
- Results
- Posted 11 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- reverse existing lymphoid tissue fibrosis,
- restore lymphoid tissue architecture,
- increase the number and improve the function of peripheral and lymphatic CD4 T cells,
- decrease levels of systemic immune activation (IA),
- decrease size of the HIV reservoir, and
- be safe and well tolerated.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan | Experimental | Drug: Losartan |
| Sugar Pill | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LosartanAlso: CozaarParticipants 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. | Drug | Losartan |
| Placeboone tablet by mouth daily | Drug | Sugar Pill |
Primary outcome
Collagen Deposition in LT
Time frame: 30 months
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.
Integrity of the Fibroblastic Reticular Cell Network (FRCn)
Time frame: 30 months
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.
41 secondary outcomes
Frequency of CD4+ T Cells
Time frame: 30 months
Frequency TUNEL+CD3+CD8+ T Cells
Time frame: 30 months
Frequency of Cells Expressing TGF-beta and Lymphotoxin-beta
Time frame: 30 months
Serum Concentration of IL-7
Time frame: 30 months
Serum Concentration of TGF-beta
Time frame: 30 months
Immune Response to HPV Vaccination
Time frame: 30 months
Frequency of Activated T-cell Populations - Immunofluorescent Staining
Time frame: 30 months
Percent of Activated T Cells in PBMCs - Flow Cytometry
Time frame: 30 months
Percent of Activated Macrophages in PBMCs - Flow Cytometry
Time frame: 30 months
Percent of Activated Dendritic Cells in PBMCs - Flow Cytometry
Time frame: 30 months
Percent of Activated T Cells in LT - Flow Cytometry
Time frame: 30 months
Percent of Activated Macrophages in LT - Flow Cytometry
Time frame: 30 months
Percent of Activated Dendritic Cells in LT - Flow Cytometry
Time frame: 30 months
Intracellular Concentration of IL-17 in PBMCs
Time frame: 30 months
Intracellular Concentration of IFNg in PBMCs
Time frame: 30 months
Intracellular Concentration of IL-2 in PBMCs
Time frame: 30 months
Intracellular Concentration of TNF in PBMCs
Time frame: 30 months
Intracellular Concentration of IL-10 in PBMCs
Time frame: 30 months
Intracellular Concentration of GM-CSF in PBMCs
Time frame: 30 months
Intracellular Concentration of IL-17 in LT
Time frame: 30 months
Intracellular Concentration of IFNg in LT
Time frame: 30 months
Intracellular Concentration of IL-2 in LT
Time frame: 30 months
Intracellular Concentration of TNF in LT
Time frame: 30 months
Intracellular Concentration of IL-10 in LT
Time frame: 30 months
Intracellular Concentration of GM-CSF in LT
Time frame: 30 months
Plasma Concentration of LPS
Time frame: 30 months
Plasma Concentration of sCD14
Time frame: 30 months
Plasma Concentration of I-FABP
Time frame: 30 months
Plasma Concentration of IL-1b
Time frame: 30 months
Plasma Concentration of IL-1RA
Time frame: 30 months
Plasma Concentration of IL-6
Time frame: 30 months
Plasma Concentration of TNF
Time frame: 30 months
Plasma Concentration of Amyloid A
Time frame: 30 months
Plasma Concentration of CRP
Time frame: 30 months
Plasma Concentration of D-dimer
Time frame: 30 months
Frequency of HIV RNA+ and DNA+ Cells in LN - Radiolabeled ISH
Time frame: 30 months
Frequency of HIV RNA+ and DNA+ Cells in LN - RNAscopeTM in Situ Technology
Time frame: 30 months
Frequency of HIV RNA+ and DNA+ Cells in GALT - Radiolabeled in Situ Hybridization (ISH)
Time frame: 30 months
Frequency of HIV RNA+ and DNA+ Cells in GALT - RNAscopeTM in Situ Technology
Time frame: 30 months
Concentration of Losartan and Antiretrovirals (ARVs)
Time frame: 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for HIV Infection
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Timothy Schacker, M.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Losartan in people with HIV Infection and HIV Infections, run by University of Minnesota 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?
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 11 Dec 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2020). 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?
Collagen Deposition in LT (time frame: 30 months). The study lists 2 primary outcomes in all. 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 11 Dec 2020.