Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1

• Status: Completed
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy, safety and tolerability of switching from the older, established single tablet regimen of ATRIPLA® (EFV/FTC/TDF) to a new single tablet regimen of BIKTARVY® (BIC/FTC/TAF), in HIV-1 infected adult subjects who are virologically suppressed (HIV-1 RNA<50 copies/mL).

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

Details

• Lead Sponsor: Midland Research Group, Inc.
• Collaborator: Gilead Sciences
• Treatments: Emtricitabine; Emtricitabine tenofovir alafenamide; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• HIV positive

• On a stable antiretroviral regimen consisting of ATRIPLA® for at least the 6 consecutive months preceding Screening Visit.

• Plasma HIV-1 RNA concentrations at undetectable levels for at least 6 consecutive months prior to the screening visit and have HIV RNA< 50 copies/mL at the Screening Visit.

• Estimated GFR ≥30mL/min according to the Cockcroft-Gault formula for creatinine clearance.

• Hepatic transaminases (AST and ALT) ≤5x upper limit of normal (ULN)

• Total bilirubin ≤1.5 mg/dL, or normal direct bilirubin.

• Adequate hematologic function (hemoglobin ≥ 8.5g/dL; platelets ≥ 50,000/mm3; absolute neutrophil count ≥1,000/mm3)

• Female subjects of reproductive potential using a reliable and consistent method of birth control for at least three months prior to study dosing. Male subjects should use condoms when engaging in intercourse of reproductive potential.

• The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

Exclusion Criteria:

• A new AIDS-defining condition diagnosed within 30 days prior to screening.

• Individuals with decompensated cirrhosis. (i.e. ascites, encephalopathy, etc.)

• Pregnancy

• A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma. Individuals with cutaneous KS are eligible but must not have received any systemic therapy for KS within 30 days prior to baseline.

• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline.

• Life expectancy < 1 year.

• Subject participation in any clinical trial without prior approval from the Investigator.

• Concomitant use of disallowed agents from Table 2

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