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: May 12, 2016

Last verified: May 2016

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 Intervention Model: Parallel Assignment Masking: Double Blind (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:

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/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


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

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:	May 12, 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

ClinicalTrials.gov processed this record on July 17, 2017

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