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

Phase 4

Completed

• Conditions: HIV
• Interventions: Drug: Placebo; Drug: Lisinopril

• Registration Number: NCT01535235
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-17
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-03-01
• Results First Submitted QC: 2016-03-01
• Results First Posted: 2016-03-31
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo group
ACE Inhibitor	Lisinopril	Active group

Primary Outcome Measures

Name	Time	Method
Change in HIV RNA (Copies/Million Rectal Cells)	22 weeks	Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline

Secondary Outcome Measures

Name	Time	Method
Change in HIV DNA (Copies/Million Rectal Cells)	22 weeks	Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline

Trial Locations

Locations (1)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States