Pilot Study of Diflunisal in HIV-infected Adults

• Status: Terminated
• Trial end date: 2016-10-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Diflunisal

Criteria

Inclusion Criteria:

1. Adult men and women aged 19 years or over

2. HIV positive by ELISA and Western blot, at least 3 months prior to screening

3. No antiretroviral therapy within 3 months prior to screening

4. Plasma HIV RNA (viral load) > 2,500 copies/mL at screening

5. Current CD4 cell count >350 cells/mm3 at screening

6. Adequate renal function as demonstrated by eGFR >60 mL/min. at screening

Exclusion Criteria:

1. Pregnancy or breast-feeding

2. Any HIV-associated symptom or condition (e.g. nephropathy) for which standard antiretroviral therapy is indicated immediately

3. History of peptic ulcer and/or gastrointestinal bleeding

4. Allergy to ASA, other salicylates, or NSAIDs

5. Currently receiving treatment with an ACE inhibitor, ASA, anticoagulants, antacids containing aluminum hydroxide, cyclosporine, diuretics, systemic glucocorticoids, lithium, methotrexate, or other NSAIDs

6. Significant hepatic impairment or active liver disease - screening AST, ALT, or bilirubin >2.5x upper limit of normal (ULN)

7. Hyperkalemia - screening serum potassium >5.5 mmol/L

8. Anemia - screening hemoglobin <85 g/L