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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: HIV

Treatments: Drug: Lisinopril; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01535235

11-08132

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

ACE Inhibitor

Active Comparator group

Description:

Active group

Treatment:

Drug: Lisinopril

Placebo

Placebo Comparator group

Description:

Placebo group

Treatment:

Drug: Placebo