NCT01676363

Pilot Study of Diflunisal in HIV-infected Adults

Terminated Phase 4 Last updated 25 October 2017

What this trial tests

Phase 4 trial testing Diflunisal in HIV Infection in 8 participants. Terminated before completion.

Timeline

1 March 2013

Primary endpoint
12 October 2016

12 October 2016

Quick facts

Lead sponsor	University of British Columbia
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	1 March 2013
Primary completion	12 October 2016
Estimated completion	12 October 2016
Sites	1 location across Canada

Drugs / interventions tested

• Diflunisal (DIFLUNISAL) — full drug profile →

Conditions studied

• HIV Infection — all drugs for HIV Infection →

Sponsor

University of British Columbia

Who can join

19 and older, any sex, with HIV Infection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in plasma HIV RNA level
  Time frame: between baseline and end of 4-week treatment, and between end of treatment and end of 2-week washout
  Plasma HIV RNA changes between baseline and end of 4-week treatment, and between end of treatment and end of 2-week washout

Sponsor's own description

Diflunisal is an anti-inflammatory drug (like ASA or ibuprofen) that has been used as a painkiller for 20 years. Recent research shows that it may have an anti-HIV effect in the laboratory. Approximately 20 HIV-infected adults who are not receiving antiretroviral therapy will be given diflunisal by mouth twice daily for 4 weeks, at a dose that has been shown to be safe when used to treat pain. Subjects will be monitored closely for safety and will have frequent blood tests during the study to see if the drug has any effect on the level of HIV in their blood.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.