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

This study is currently recruiting participants.
Verified October 2012 by University of California, San Francisco
Sponsor:
Collaborator:
amfAR, The Foundation for AIDS Research
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01535235
First received: February 9, 2012
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lisinopril
U.S. FDA Resources

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

Primary Outcome Measures:
  • Change in HIV RNA (copies/mil CD4) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in mean baseline GALT (gut-associated lymphoid tissue) RNA


Secondary Outcome Measures:
  • Change in HIV DNA (copies/mil CD4) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change in mean baseline GALT (gut-associated lymphoid tissue) DNA


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535235

Contacts
Contact: Hiroyu Hatano, MD 415-476-4082 ext 122 hhatano@php.ucsf.edu

Locations
United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Hiroyu Hatano, MD     415-476-4082 ext 122     hhatano@php.ucsf.edu    
Principal Investigator: Hiroyu Hatano, MD            
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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01535235     History of Changes
Other Study ID Numbers: 11-08132
Study First Received: February 9, 2012
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013