Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saint Michael's Medical Center
• Collaborator: ViiV Healthcare
• Treatments: Dolutegravir; Lamivudine

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)