NCT01928927

Telmisartan to Reduce AIDS-Related Fibrotic and Inflammatory Contributors (TRAFIC Study)

Effects of Telmisartan on Fibrotic and Inflammatory Contributors to End-Organ Disease in HIV-Infected Patients Well Controlled on Antiretroviral Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this study was to see if a drug called telmisartan would decrease fibrosis (scarring) and inflammation (irritation) in people who are infected with HIV and doing well on their HIV medications. The study was also done to see what effects telmisartan has on other signs of disease and inflammation in the body, and to see whether people who have HIV can take telmisartan safely and without side effects that make them want to stop the drug. Telmisartan is FDA-approved for treating high blood pressure and decreasing the chance of heart attacks and strokes in people over the age of 55 years of age who are at high risk for these events.

Detailed description

This was a multicenter, randomized, open label, phase IIb, two-arm study to evaluate the effects of telmisartan on fibrotic and inflammatory contributors to end-organ disease in HIV-infected subjects well controlled on antiretroviral therapy (ART). Participants were randomized 2:1 to the telmisartan and control arms. The participants on telmisartan took 40 mg telmisartan daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48. The participants in the control arm did not take any study medication, but did undergo all evaluations. All participants were followed for 48 weeks after randomization. The study clinic visits included Step 1 entry, Step 2 entry, and weeks 4, 12, 24, 36, 48. Biopsies for the primary outcomes were collected at Step 1 entry and Week 48. The evaluations of safety (clinical assessment for signs and symptoms, diagnoses, laboratory tests) were done at Step 2 entry and weeks 4, 12, 24, 36, 48. The co-primary objectives assessed the effects of telmisartan for 48weeks on lymph node and adipose tissue collagen I deposition. Currently, the results are entered for the primary outcome measures only. The results on the secondary outcomes will be posted when they become available.

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	Telmisartan	Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2013-08-27
• Last updated: 2021-08-03
• Results posted: 2017-04-12

Locations

12 sites across 2 countries: United States, Puerto Rico