Status:
UNKNOWN
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
Lead Sponsor:
Saint Michael's Medical Center
Collaborating Sponsors:
ViiV Healthcare
Conditions:
Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04826562
Start Date
September 26 2021
End Date
December 30 2023
Last Update
October 11 2023
Active Locations (1)
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1
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102