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OpenTrials
Completed

NCT Number: NCT01535235

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

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.

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lisinopril

Drug

Lisinopril 20mg QD x 24 weeks

Placebo

Drug

Placebo QD x24wks

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • amfAR, The Foundation for AIDS Research

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 17, 2012
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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