Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)

NCT04826562 | Unknown Phase 4 FDA Drug

• 1 other identifier: 09/21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• Virologic Failure

  To determine the % of virologic failures (VL ≥ 50 copies/mL at week 48 using the FDA ITT, Snapshot analysis

  48 weeks

Secondary Outcomes (2)

• Virologic Suprresion

  96 weeks

• Retrospective Baseline Resistance

  96 weeks

Study Arms (1)

dolutegravir/lamivudine

EXPERIMENTAL

dolutegravir/lamivudine

Drug: Dolutegravir/Lamivudine

Interventions

Dolutegravir/Lamivudine DRUG

single tablet antiretroviral

Also known as: Dovato

dolutegravir/lamivudine

Eligibility Criteria

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

You may qualify if:

• Confirmed HIV-1 infection
• Age of 18 years or older
• On Biktarvy for at \>24 weeks with HIV viral load \< 50 copies /mL for \> 6 months immediately prior to enrollment
• 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
• Willingness to sign the informed consent
• If history of virologic failure must be fully suppressed (HIV-1 RNA\<50 copies/mL) for at least 12 months before screening visit
• No prior HIV genotype or phenotype available

You may not qualify if:

• Hypersensitivity to dolutegravir and/or lamivudine
• History of virologic failure while on an integrase inhibitor
• Taking any medication contraindicated for co-administration with dolutegravir and/or lamivudine according to manufacturer's current medication package inserts
• HIV-1 RNA ≥50 copies/mL (confirmed) in the past 48 weeks after initial suppression on therapy to HIV-1 RNA \<50 copies/mL
• 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.
• Pregnant women, women actively seeking to become pregnant, and women of child-bearing potential who are not using effective contraception
• Severe hepatic impairment (Child-Pugh C)
• Critically ill and/or unable to take oral medications
• Any condition (social or medical) which, in the opinion of the investigator, would make study participation unsafe for the subject
• Creatinine clearance \< 30 mL/min/1.73m2 via CKD-EPI method
• ALT \> 5x the upper limit of normal (ULN) or ALT \> 3x ULN and total bilbirubin \>1.5x ULN (and \>35% directed bilirubin)
• Subjects with an anticipated need for hepatitis C virus therapy with interferon and/or ribavirin prior to the primary endpoint

Sponsors & Collaborators

• Saint Michael's Medical Center: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Saint Michael's Medical Center

Newark, New Jersey, 07102, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

dolutegravir; Lamivudine

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jihad Slim, MD

  Saint Michael's Medical Cettner

  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: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Infectious Diseases

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 1, 2021
• Study Start: September 26, 2021
• Primary Completion: October 6, 2023
• Study Completion: December 30, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)