Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Saint Michael's Medical Center
With
ViiV Healthcare
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
