Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)

Phase 4

Active, not recruiting

• Conditions: Human Immunodeficiency Virus
• Interventions: Drug: Dolutegravir/Lamivudine

• Registration Number: NCT04826562
• Lead Sponsor: Saint Michael's Medical Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-28
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Study Start: 2021-09-26
• Status Verified: 2023-10
• Primary Completion: 2023-10-06
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dolutegravir/lamivudine	Dolutegravir/Lamivudine	dolutegravir/lamivudine

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Saint Michael's Medical Center; 🇺🇸 Newark, New Jersey, United States