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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01535235
First Posted: February 17, 2012
Last Update Posted: June 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
amfAR, The Foundation for AIDS Research
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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 Intervention Phase
HIV Drug: Lisinopril Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 31
Study Start Date: February 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACE Inhibitor
Active group
Drug: Lisinopril
Lisinopril 20mg QD x 24 weeks
Placebo Comparator: Placebo
Placebo group
Drug: Placebo
Placebo QD x24wks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01535235     History of Changes
Other Study ID Numbers: 11-08132
First Submitted: February 9, 2012
First Posted: February 17, 2012
Results First Submitted: March 1, 2016
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