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

This study has been completed.
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: March 1, 2016
Last verified: March 2016
  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:


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 ] [ Designated as safety issue: No ]
    Change in GALT (gut-associated lymphoid tissue) RNA from baseline


Secondary Outcome Measures:
  • Change in HIV DNA (Copies/Million Rectal Cells) [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
    Change in GALT (gut-associated lymphoid tissue) DNA from baseline


Enrollment: 30
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 9, 2012
Results First Received: March 1, 2016
Last Updated: March 1, 2016
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 27, 2016