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

May 12, 2016 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo group
Drug: Placebo
Placebo QD x24wks
ACTIVE_COMPARATOR: ACE Inhibitor
Active group
Drug: Lisinopril
Lisinopril 20mg QD x 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
22 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

amfAR, The Foundation for AIDS Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

February 9, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (ESTIMATE)

February 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-08132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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