Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF

NCT04585737 | Completed Phase 4 Results FDA Drug

• 1 other identifier: OIC 008
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine

Conditions

HIV I Infection

Keywords

switch study; dovato; biktarvy

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure is to Evaluate the Efficacy of Switching From B/F/TAF to DTG/3TC Versus Continuing B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48

  percentage with HIV-1 RNA ≥50 copies/mL at Week 48 in each treatment arm

  48 weeks

Secondary Outcomes (9)

• The Secondary Outcome Measure is to Evaluate the Efficacy of Switching to DTG/3TC From B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA≥ 50 Copies/mL at Week 24

  24 weeks

• The Secondary Outcome Measure is to Evaluate the Efficacy of Switching to DTG/3TC From B/F/TAF as Determined by the Proportion of Participants With HIV-1 RNA<50 Copies/mL at Week 48

  48 weeks

• The Secondary Outcome Measure is to Measure the Incidence and Severity of Grade 2-5 Drug-related Adverse Events and Laboratory Abnormalities (Graded Using DAIDs Grading Scale) Through 48 Weeks

  48 weeks

• The Secondary Outcome Measure is to Evaluate the Proportion of Participants That Discontinue Treatment Through 48 Weeks in Each Treatment Arm and Reasons for Discontinuation

  48 weeks

• The Secondary Outcome Measure is to Evaluate the Effects of DTG/3TC Once Daily on Fasting Total Cholesterol Over Time Compared to B/F/TAF Through 48 Weeks

  48 weeks

Study Arms (2)

Treatment group 1

EXPERIMENTAL

Treatment Group 1 (n=148): FDC of DTG/3TC (50mg/300mg) administered orally, once daily (QD), without regard to food.

Drug: Dolutegravir / Lamivudine Pill

Treatment group 2

ACTIVE COMPARATOR

Treatment Group 2 (n=74): Stay on baseline regimen consisting of FDC of B/F/TAF (50mg/200mg/ 25mg) (taken as prescribed) without regard to food.

Drug: Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill

Interventions

Dolutegravir / Lamivudine Pill DRUG

Experimental

Also known as: Dovato

Treatment group 1

Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill DRUG

Active comparator

Also known as: Biktarvy

Treatment group 2

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older at the time of signing the informed consent
• TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
• HIV-1 infected men or women.
• Must have a stable form of insurance that is expected to continue without significant changes for at least 48 weeks
• Documented evidence of at least two plasma HIV-1 RNA measurements \<50 c/mL at least 3 months apart prior to Day 1 (the screening HIV-1 RNA can count as the second measurement)
• Plasma HIV-1 RNA \<50 c/mL at Screening.
• Must be on uninterrupted B/F/TAF for at least 3 months prior to screening
• SEX
• Male or female A female subject is eligible to participate if she is not pregnant \[as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screen and a negative urine hCG test at Day
• /Randomization (a local serum hCG test at Randomization is allowed if it can be done, and results obtained, within 24 hours prior to randomization)\], not lactating, and at least one of the following conditions applies:
• Non-reproductive potential defined as:
• Pre-menopausal females with one of the following:
• o Documented tubal ligation
• Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
• Hysterectomy

You may not qualify if:

• CONCURRENT CONDITIONS/MEDICAL HISTORY
• Women who are breastfeeding or plan to become pregnant or breastfeed during the study.
• Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification \[16\].
• Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (antiHBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV DNA as follows:
• Subjects positive for HBsAg are excluded.
• Subjects negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
• Note: Subjects positive for anti-HBc (negative HBsAg status) and positive for antiHBs (past and/or current evidence) are immune to HBV and are not excluded. AntiHBc must be either total anti-HBc or anti-HBc immunoglobulin G (IgG), and NOT anti-HBc IgM.
• Anticipated need for any hepatitis C virus (HCV) therapy during the first 48 weeks of the study
• Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment). Subjects who are at least 7 days post completed treatment are eligible.
• History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
• Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
• Subjects who in the investigator's judgment, poses a significant suicidality risk.
• Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening
• Treatment with any of the following agents within 28 days of Screening

Sponsors & Collaborators

• Charlotte-Paige Rolle, MD: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

MeSH Terms

Interventions

dolutegravir; Lamivudine; bictegravir; Emtricitabine; tenofovir alafenamide; bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Results Point of Contact

• Title: Wendy Wert, Clinical Research manager
• Organization: Orlando Immunology Center

wwert@oicorlando.com

4076473960

Study Officials

• Charlotte-Paige Rolle, MD

  Orlando Immunology Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, open-label, active-controlled study of virologically suppressed participants living with HIV

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 14, 2020
• Study Start: October 5, 2020
• Primary Completion: August 3, 2023
• Study Completion: August 10, 2023
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)