Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)

• Status: Not yet recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/COB/FTC/TAF) is a coformulated STR, is the only protease inhibitor based STR, and is noted for its high tolerability3. These traits have the potential to improve adherence in patients who have intolerance to the integrase inhibitor class. We propose a two part study design to evaluate if patients who have suboptimal adherence due to integrase inhibitor intolerance may better tolerate Symtuza and subsequently have improved adherence.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Midland Research Group, Inc.
• Collaborator: Janssen Pharmaceuticals
• Treatments: Integrase Inhibitors

Criteria

Inclusion Criteria:

• ≥ 18 years of age.

• HIV positive receiving ART of any type.

• Currently on an integrase containing regimen AND Reports non-adherent due to medication intolerance.

• GFR≥30mL/min.

• AST/ALT ≤ 3 times upper limit of normal. (AST- U/L 10-40), (ALT- U/L 9-46)

• Total bilirubin of ≤1.5 mg/dL.

Exclusion Criteria:

• Known resistance to darunavir or tenofovir

• Known intolerance to Symtuza or its components

• Current pregnancy

• Requires continued use of any of the agents in table 6.2.3.2.4

• Cirrhosis, regardless of compensation status

• Active, serious infections within 30 days of baseline

• History of malignancy within 5 years of baseline, except cutaneous Kaposi's sarcoma, basal cell or resected non-invasive cutaneous squamous cell carcinoma

• Life expectancy of less than a year

• Participation in any other investigation study 30 days prior to enrollment