HIV | ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
HIV research study
What is the primary objective of this 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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:LisinoprilLisinopril 20mg QD x 24 weeks
Drug:PlaceboPlacebo QD x24wks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ACE InhibitorActive group
Start Date: February 2012
Completed Date: December 2014
Phase: Phase 4
Primary Outcome: Change in HIV RNA (Copies/Million Rectal Cells)
Secondary Outcome: Change in HIV DNA (Copies/Million Rectal Cells)
Study sponsors, principal investigator, and references
Principal Investigator: Hiroyu Hatano, MD
Lead Sponsor: University of California, San Francisco
Collaborator: amfAR, The Foundation for AIDS Research