Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01046682 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Salsalate to Treat Endothelial Dysfunction in HIV-infected Adults
A Phase 2 study of HIV and Inflammation, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01046682: Completed Phase 2 study of HIV and Inflammation, sponsored by University Hospitals Cleveland Medical Center.
NCT01046682 is a Phase 2 study of HIV and Inflammation that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 40 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01046682, a Phase 2 study of HIV and Inflammation, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase II, open label, randomized-controlled pilot study designed to study both the efficacy and safety of salsalate in decreasing endothelial cell dysfunction, systemic inflammation, and insulin resistance in HIV-infected adults. The investigators hypothesis is that salsalate will reduce inflammation and therefore endothelial cell activation and insulin resistance. The sample size will be 40, with an equal number of people being randomized to one of two groups. The first arm will be randomized to salsalate therapy. The second arm will act as a control group. The study duration will be 13 weeks.
Primary Outcome
Flow mediated dilation (FMD) of the brachial artery was measured by ultrasound. This is a measure of endothelial dependent endothelial cell function. Flow mediated dilation is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia. Reactive hyperemia occurred after occluding the brachial artery with a blood pressure cuff for 5 minutes.
Conditions Studied
Interventions
- DRUG Salsalate
Study Locations (1)
Ohio
- University Hospitals Case Medical Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-01 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT01046682 record still lists
NCT01046682 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (91% lower).
The record links to 4 conditions, with HIV appearing as the primary indexed condition, and to 1 intervention - of which Salsalate is the first listed.
NCT01046682 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01046682 about?
NCT01046682 is a clinical study titled "Safety and Efficacy of Salsalate to Treat Endothelial Dysfunction in HIV-infected Adults". This is a phase II, open label, randomized-controlled pilot study designed to study both the efficacy and safety of salsalate in decreasing endothelial cell dysfunction, systemic inflammation, and insulin resistance in HIV-infected adults. The investigators hypothesis is that salsalate will reduce i...
What is the current status of trial NCT01046682?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2009-01. Estimated completion is 2009-07.
What conditions does trial NCT01046682 study?
This clinical trial studies the following conditions: HIV, Inflammation, Insulin Resistance, Endothelial Dysfunction.
What interventions are being tested in trial NCT01046682?
The interventions under investigation include: Salsalate (DRUG).
Who is sponsoring clinical trial NCT01046682?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01046682 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01046682's enrollment target sits among peer trials
40 243rd of 303 higher than 58 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluating Gardasil HPV Vaccine Humoral and Cellular Immune Responses in People With and Without HIV
RECRUITING · Phase 2
-
Improving Physical Ability and Cellular Senescence Elimination in HIV
RECRUITING · Phase 2
-
Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV
RECRUITING · Phase 2
-
Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide
RECRUITING · Phase 2
-
Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
RECRUITING · Phase 2
-
A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia