Human Immunodeficiency Virus
Conditions
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
Interventions
DRUGDolutegravir/Lamivudine
single tablet antiretroviral
Sponsors
ViiV Healthcare
Saint Michael's Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Virologic Failure | 48 weeks | To determine the % of virologic failures (VL ≥ 50 copies/mL at week 48 using the FDA ITT, Snapshot analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retrospective Baseline Resistance | 96 weeks | to determine the percentage baseline resistance after 96 weeks of treatment |
| Virologic Suprresion | 96 weeks | To determine the % of subjects remaining virologically suppressed at weeks 48 and 96 using the Snapshot algorithm |
Countries
United States
Outcome results
None listed