Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)

NCT ID: NCT04826562

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-26
• Study Completion Date: 2023-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dolutegravir/lamivudine

dolutegravir/lamivudine

Group Type: EXPERIMENTAL

Dolutegravir/Lamivudine

Intervention Type: DRUG

single tablet antiretroviral

Interventions

Dolutegravir/Lamivudine

single tablet antiretroviral

Intervention Type: DRUG

Other Intervention Names

Dovato

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ViiV Healthcare

INDUSTRY

Sponsor Role: collaborator

Saint Michael's Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jihad Slim, MD

Chief of Infectious Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jihad Slim, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Michael's Medical Cettner

Locations

Saint Michael's Medical Center

Newark, New Jersey, United States

Countries

United States

Other Identifiers

09/21

Identifier Type: -

Identifier Source: org_study_id