Phase 4
Completed N=31
ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study
Source: ClinicalTrials.gov NCT01535235 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Change in HIV RNA (Copies/Million Rectal Cells) — 1.1; -0.2 copies/million rectal cells — p=0.63
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HIV RNA (Copies/Million Rectal Cells) |
1.1; -0.2 | 0.63 |
| SECONDARY Change in HIV DNA (Copies/Million Rectal Cells) |
-38.4; -53.8 | 0.63 |
Eligibility Criteria
Inclusion Criteria include:
- Stable HAART with maintenance of plasma HIV RNA levels below level of detection ( 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.
Data sourced from ClinicalTrials.gov (NCT01535235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.