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

NCT03502005 | Completed Phase 4 FDA Drug

• 1 other identifier: IN-US-380-4543
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• assess proportion of patients who develop increase in HIV-1 RNA viral load of ≥ 50 copies/mL

  by week 24

  24 weeks

Secondary Outcomes (6)

• assess stability of kidney function by serial measuring of serum creatinine mg/dL

  48 weeks

• Assess effect on restoration of immune markers by serial measurement of CD4+ cells

  48 weeks

• assess effect on lipid cardiovascular risk factors by serial measurement of triglycerides and HDL/LDL cholesterol

  48 weeks

• assess proportion of patients who continue to have HIV-1 RNA measured <50 copies/mL

  48 weeks

• Assess patient reported outcomes by two validated patient questionnaires Philadelphia Sleep Quality Index and HIV Symptom Index

  48 weeks

Study Arms (1)

BIKTARVY®

EXPERIMENTAL

initiation of single pill once daily bictegravir/emtricitabine/tenofovir alafenamide from prior efavirenz/emtricitabine/tenofovir DF

Drug: bictegravir/emtricitabine/tenofovir alafenamide

Interventions

bictegravir/emtricitabine/tenofovir alafenamide DRUG

Discontinue ATRIPLA® and initiate BIKTARVY®

Also known as: BIKTARVY® (BIC/FTC/TAF)

BIKTARVY®

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Midland Research Group, Inc.: lead
• Gilead Sciences: collaborator

Study Sites (1)

Midland Research Group, Inc

Oakland Park, Florida, 33334, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Condition Hierarchy (Ancestors)

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

Study Officials

• Noah Lee, DO

  Midland Research Group, Inc.

  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: SPONSOR

Model Details: Prospective 48 week single cohort study to evaluate the efficacy and safety of switching from ATRIPLA to BIKTARVY® in HIV-1 infected adult subjects who are virologically suppressed (HIV-1 RNA \< 50 copies/mL).

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 18, 2018
• Study Start: March 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)