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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01535235
• Other study ID #: 11-08132
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2012
• Last updated: August 14, 2015
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Lisinopril
Lisinopril 20mg QD x 24 weeks
• Placebo
Placebo QD x24wks

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	amfAR, The Foundation for AIDS Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HIV RNA (copies/mil CD4)	Change in mean baseline GALT (gut-associated lymphoid tissue) RNA	24 weeks	No
Secondary	Change in HIV DNA (copies/mil CD4)	Change in mean baseline GALT (gut-associated lymphoid tissue) DNA	24 weeks	No