Status and phase
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About
An open-label, pilot study of switching patients to Dovato who are currently taking Bitarvy who are virological suppressed (HIV-1 < 50 copies/mL
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Sex
Ages
Volunteers
Inclusion criteria
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:
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)
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Central trial contact
James P Fallon, MS; Herbert Galang
Data sourced from clinicaltrials.gov
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