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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV

NCT01852942

HIV Infection HIV Infections

COMPLETED PHASE2

Study of Protease Inhibitor Regimen Switch in HIV-1 Infected Patients With Undetectable Viral Load to Prove the Non-inferiority of Once Daily Dose Regimen Versus the Current Twice Daily Regimen to Maintain the Viral Load Under the Limit of Detection.

NCT00849160

HIV-1 Infection HIV Infections

COMPLETED PHASE3

Latent HIV-1, Viral Suppress and Hope for HIV Cure

NCT04938518

HIV-1-infection

UNKNOWN

Pilot Study of Raltegravir Lipodystrophy IISP

NCT01164605

HIV Infection

UNKNOWN NA

Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial

NCT02049307

Inflammation Fibrosis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACE Inhibitor

Active group

Group Type ACTIVE_COMPARATOR

Lisinopril

Intervention Type DRUG

Lisinopril 20mg QD x 24 weeks

Placebo

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo QD x24wks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lisinopril

Lisinopril 20mg QD x 24 weeks

Intervention Type DRUG

Placebo

Placebo QD x24wks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No