Pilot Study of Diflunisal in HIV-infected Adults

NCT01676363 | Terminated Phase 4

• 1 other identifier: H11-03547
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infection

Keywords

diflunisal; anti-inflammatory agents, non-steroidal; antiviral agents

Outcome Measures

Primary Outcomes (1)

• Change in plasma HIV RNA level

  Plasma HIV RNA changes between baseline and end of 4-week treatment, and between end of treatment and end of 2-week washout

  between baseline and end of 4-week treatment, and between end of treatment and end of 2-week washout

Secondary Outcomes (6)

• Clinical adverse events including serious adverse events

  from screening until final study visit on Day 50

• Clinically significant changes in laboratory parameters

  between screening and Day 50

• Slope of HIV RNA change

  during 4-week treatment and 2-week washout phases

• Changes in inflammatory biomarkers

  during 4-week treatment and 2-week washout phases

• Changes in T cell subsets

  during 4-week treatment and 2-week washout phases

Study Arms (1)

Diflunisal

EXPERIMENTAL

Drug: Diflunisal

Interventions

Diflunisal DRUG

Open-label diflunisal 500 mg twice daily for 4 weeks

Diflunisal

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and women aged 19 years or over
• HIV positive by ELISA and Western blot, at least 3 months prior to screening
• No antiretroviral therapy within 3 months prior to screening
• Plasma HIV RNA (viral load) \> 2,500 copies/mL at screening
• Current CD4 cell count \>350 cells/mm3 at screening
• Adequate renal function as demonstrated by eGFR \>60 mL/min. at screening

You may not qualify if:

• Pregnancy or breast-feeding
• Any HIV-associated symptom or condition (e.g. nephropathy) for which standard antiretroviral therapy is indicated immediately
• History of peptic ulcer and/or gastrointestinal bleeding
• Allergy to ASA, other salicylates, or NSAIDs
• Currently receiving treatment with an ACE inhibitor, ASA, anticoagulants, antacids containing aluminum hydroxide, cyclosporine, diuretics, systemic glucocorticoids, lithium, methotrexate, or other NSAIDs
• Significant hepatic impairment or active liver disease - screening AST, ALT, or bilirubin \>2.5x upper limit of normal (ULN)
• Hyperkalemia - screening serum potassium \>5.5 mmol/L
• Anemia - screening hemoglobin \<85 g/L

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Immunodeficiency Clinic, St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Diflunisal

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Julio Montaner, MD

  Providence Health Care/ University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Julio Montaner

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: August 30, 2012
• Study Start: March 1, 2013
• Primary Completion: October 12, 2016
• Study Completion: October 12, 2016
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

CA (1)