Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)

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

Official Title
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Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)

Conditions
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Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: Dolutegravir/Lamivudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Unstable liver disease, cirrhosis, and/or known biliary abnormalities (except for hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dolutegravir/lamivudine<br>dolutegravir/lamivudine | Drug: Dolutegravir/Lamivudine<br>* single tablet antiretroviral<br>* Other names: Dovato;|

What is the study measuring?
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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 |