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

University of California, San Francisco31 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

HIV

Interventions

LisinoprilDRUG

Lisinopril 20mg QD x 24 weeks

PlaceboDRUG

Placebo QD x24wks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

San Francisco General Hospital

San Francisco, California, United States

Outcomes

Primary Outcomes

Change in HIV RNA (Copies/Million Rectal Cells)

Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline

Time frame: 22 weeks

Secondary Outcomes

Change in HIV DNA (Copies/Million Rectal Cells)

Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline

Time frame: 22 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.