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

Primary Purpose

HIV

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lisinopril
Placebo
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, Lymphoid fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ACE Inhibitor

Placebo

Arm Description

Active group

Placebo group

Outcomes

Primary Outcome Measures

Change in HIV RNA (Copies/Million Rectal Cells)
Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline

Secondary Outcome Measures

Change in HIV DNA (Copies/Million Rectal Cells)
Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline

Full Information

First Posted
February 9, 2012
Last Updated
May 12, 2016
Sponsor
University of California, San Francisco
Collaborators
amfAR, The Foundation for AIDS Research
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1. Study Identification

Unique Protocol Identification Number
NCT01535235
Brief Title
ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
Official Title
ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
amfAR, The Foundation for AIDS Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
HIV, Lymphoid fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACE Inhibitor
Arm Type
Active Comparator
Arm Description
Active group
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group
Intervention Type
Drug
Intervention Name(s)
Lisinopril
Intervention Description
Lisinopril 20mg QD x 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo QD x24wks
Primary Outcome Measure Information:
Title
Change in HIV RNA (Copies/Million Rectal Cells)
Description
Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline
Time Frame
22 weeks
Secondary Outcome Measure Information:
Title
Change in HIV DNA (Copies/Million Rectal Cells)
Description
Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroyu Hatano, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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