Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND) (Sound)

An open-label, pilot study of switching patients to Dovato who are currently taking Bitarvy who are virological suppressed (HIV-1 < 50 copies/mL

Study Overview

• Status: Active, not recruiting
• Conditions: Human Immunodeficiency Virus
• Intervention / Treatment: Drug: Dolutegravir/Lamivudine

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: James P Fallon, MS; Phone Number: 9738772663; Email: jfallon@primehealthcare.com
• Study Contact Backup: Name: Herbert Galang; Phone Number: 9738775162; Email: hgalang@primehealthcare.com

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • Saint Michael's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Confirmed HIV-1 infection
2. Age of 18 years or older
3. On Biktarvy for at >24 weeks with HIV viral load < 50 copies /mL for > 6 months immediately prior to enrollment
4. Agree to consistently use an effective method of contraception (see Appendix: Highly Effective Methods for Avoiding Pregnancies in Females of Reproductive Potential) for women of child-bearing potential
5. Willingness to sign the informed consent
6. If history of virologic failure must be fully suppressed (HIV-1 RNA<50 copies/mL) for at least 12 months before screening visit
7. No prior HIV genotype or phenotype available

Exclusion Criteria:

1. Hypersensitivity to dolutegravir and/or lamivudine
2. History of virologic failure while on an integrase inhibitor
3. Taking any medication contraindicated for co-administration with dolutegravir and/or lamivudine according to manufacturer's current medication package inserts
4. HIV-1 RNA ≥50 copies/mL (confirmed) in the past 48 weeks after initial suppression on therapy to HIV-1 RNA <50 copies/mL

5. 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 (anti-HBc), hepatitis B surface antigen antibody (anti-HBs) and HBV DNA as follows:

   • Participants positive for HBsAg are excluded.
   • Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.

   Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. Anti-HBc must be either total anti-HBc or anti-HBc immunoglobulin G (IgG), and NOT anti-HBc IgM. Participants with a documented history of chronic HBV and current undetectable HBV DNA while on a Biktarvy are excluded.

6. Pregnant women, women actively seeking to become pregnant, and women of child-bearing potential who are not using effective contraception
7. Severe hepatic impairment (Child-Pugh C)
8. Critically ill and/or unable to take oral medications
9. Any condition (social or medical) which, in the opinion of the investigator, would make study participation unsafe for the subject
10. Creatinine clearance < 30 mL/min/1.73m2 via CKD-EPI method
11. ALT > 5x the upper limit of normal (ULN) or ALT > 3x ULN and total bilbirubin >1.5x ULN (and >35% directed bilirubin)
12. Subjects with an anticipated need for hepatitis C virus therapy with interferon and/or ribavirin prior to the primary endpoint
13. Unstable liver disease, cirrhosis, and/or known biliary abnormalities (except for hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dolutegravir/lamivudine	Drug: Dolutegravir/Lamivudine; single tablet antiretroviral; Other Names: Dovato

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Virologic Failure	To determine the % of virologic failures (VL ≥ 50 copies/mL at week 48 using the FDA ITT, Snapshot analysis	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Virologic Suprresion	To determine the % of subjects remaining virologically suppressed at weeks 48 and 96 using the Snapshot algorithm	96 weeks
Retrospective Baseline Resistance	to determine the percentage baseline resistance after 96 weeks of treatment	96 weeks

Collaborators and Investigators

• Sponsor: Saint Michael's Medical Center
• Collaborators: ViiV Healthcare
• Investigators: Principal Investigator: Jihad Slim, MD, Saint Michael's Medical Cettner

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2021
• Primary Completion (Actual): October 6, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; Lamivudine; Dolutegravir
• Other Study ID Numbers: 09/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No