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ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study

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ClinicalTrials.gov Identifier: NCT01535235
Recruitment Status : Completed
First Posted : February 17, 2012
Results First Posted : March 31, 2016
Last Update Posted : June 16, 2016
Sponsor:
Collaborator:
amfAR, The Foundation for AIDS Research
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Drug: Lisinopril Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
Study Start Date : February 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lisinopril

Arm Intervention/treatment
Active Comparator: ACE Inhibitor
Active group
Drug: Lisinopril
Lisinopril 20mg QD x 24 weeks

Placebo Comparator: Placebo
Placebo group
Drug: Placebo
Placebo QD x24wks




Primary Outcome Measures :
  1. Change in HIV RNA (Copies/Million Rectal Cells) [ Time Frame: 22 weeks ]
    Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline


Secondary Outcome Measures :
  1. Change in HIV DNA (Copies/Million Rectal Cells) [ Time Frame: 22 weeks ]
    Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria include:

  • Stable HAART with maintenance of plasma HIV RNA levels below level of detection (< 40-75 copies/mL) for ≥ 12 months
  • > 90% adherence to HAART within preceding 30 days

Exclusion Criteria include:

  • Screening systolic blood pressure < 110mm Hg or diastolic blood pressure < 60mm Hg
  • Current use of any ACE inhibitor, angiotensin receptor blocker, or aldosterone antagonist
  • Known diabetes mellitus or cardiovascular/kidney/collagen vascular disease
  • Pregnant/breastfeeding women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535235


Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
amfAR, The Foundation for AIDS Research
Investigators
Principal Investigator: Hiroyu Hatano, MD University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01535235     History of Changes
Other Study ID Numbers: 11-08132
First Posted: February 17, 2012    Key Record Dates
Results First Posted: March 31, 2016
Last Update Posted: June 16, 2016
Last Verified: May 2016

Keywords provided by University of California, San Francisco:
HIV
Lymphoid fibrosis

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes
Lisinopril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs