ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hiv
Started Feb 2012
Typical duration for phase_4 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 9, 2012
CompletedFirst Posted
Study publicly available on registry
February 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
March 31, 2016
CompletedJune 16, 2016
May 1, 2016
2.8 years
February 9, 2012
March 1, 2016
May 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HIV RNA (Copies/Million Rectal Cells)
Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline
22 weeks
Secondary Outcomes (1)
Change in HIV DNA (Copies/Million Rectal Cells)
22 weeks
Study Arms (2)
ACE Inhibitor
ACTIVE COMPARATORActive group
Placebo
PLACEBO COMPARATORPlacebo group
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco General Hospital
San Francisco, California, 94110, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Leslie Cockerham
- Organization
- Medical College of Wisconsin
Study Officials
- PRINCIPAL INVESTIGATOR
Hiroyu Hatano, MD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2012
First Posted
February 17, 2012
Study Start
February 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
June 16, 2016
Results First Posted
March 31, 2016
Record last verified: 2016-05