DTG/3TC vs. BIC/FTC/TAF Maintenance Therapy in People Living With HIV:

Korábbi kezelés

• Previous or current therapy with dolutegravir or bictegravir.
• Any recently (\<=6 months) diagnosed clinical condition or recently (\<=6 months) initiated concomitant therapy (see Section 6.5) that may primarily affect weight or body composition. E.g., including but not limited to endocrine disorders, osteoporosis or medications to treat these clinical conditions, with the exception of ontrolled diabetes mellitus.

Más betegség

• Evidence of Hepatitis B virus infection based on at least one positive result of testing at Screening for Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (anti- HBc).
• History of allergy to study drugs or their components.
• Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (apart from hyperbilirubinemia or jaundice due to Gilbert\'s syndrome or asymptomatic gallstones);
• Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification and/or anticipated need for Hep C treatment.
• Kidney disease as defined by CKD-EPI \<50ml/min.

Laborértékek

• Liver disease as defined by ALT \>= 5x ULN or ALT \>=3xULN and Bili =1.5xULN (with \>35% direct bilirubin).

Egyéb

• Is pregnant or lactating at the screening visit or at any time during the study or is planning on becoming pregnant over the duration of the study.

• Understanding the study information provided and being capable of giving written informed consent.
• Confirmed HIV infection.
• ≥18 years of age on the day of screening.
• HIV RNA \<50 copies/mL for at least 24 weeks before screening.
• Receiving any regimen for HIV containing more than 1 pill a day or any single tablet regimen containing at least one of the following: cobicistat-boosting, efavirenz, or tenofovir disoproxyl fumarate, for at least 24 weeks before screeningPatients with TAF are expected from cobiscitat-boosting single tablet regimens containing darunavir or elvitegravir and from more-than-1-pill-a-day regimens containing TAF/FTC; their participation will be limited to ≤25%. Patients will be stratified according to the presence or not of TAF in their regimens.
• No evidence of previous viral failure.
• No known or suspected resistance to study drugs.
• Females of childbearing potential, must be using highly effective methods of contraception from study inclusion and for at least 4 weeks after last study visit; all female volunteers must be willing to undergo urine pregnancy testing at the time points specified in the schedules of events.
• Clinical stability: Participants who are healthy (other than HIV infection) as determined by the Investigator or medically qualified designee based on a medical evaluation including medical history, laboratory tests, and cardiac monitoring.