Clinical trial NCT04826562: Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
Official title: Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Human Immunodeficiency Virus
Lead sponsor: Saint Michael's Medical Center
Sponsor class: OTHER
Collaborators: name: ViiV Healthcare
First posted: 2021-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Virologic Failure
timeFrame: 48 weeks
Secondary outcomes:
measure: Virologic Suprresion
timeFrame: 96 weeks
measure: Retrospective Baseline Resistance
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
Study officials:
affiliation: Saint Michael's Medical Cettner
name: Jihad Slim, MD
role: PRINCIPAL_INVESTIGATOR
References: