EUCTR2020-003686-18-ESActive, not recruitingPhase 1
DTG/3TC vs. BIC/FTC/TAF maintenance therapy in people living with HIV: an open-label randomized clinical trial - PASO-DOBLE
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Seimc-Gesida Foundation
- Enrollment
- 550
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Understanding the study information provided and being capable of giving written informed consent
- •2. Confirmed HIV infection.
- •3. =18 years of age on the day of screening.
- •4. HIV RNA <50 copies/mL for at least 24 weeks before screening.
- •5. 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 screening. Patients with TAF are expected from cobiscitat-boosting single tablet regimens containing darunavir or elvitegravir and from morethan-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, as well as according to gender.
- •6. No evidence of previous viral failure (see appendix 4).
- •7. No known or suspected resistance to study drugs (see appendix 4).
- •8. Females of childbearing potential, must be using highly effective methods of contraception from study inclusion and 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.
- •9. 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.
- •At least 33% of the patients included will be women. We will also endeavour
- •to recruit as many non-Caucasian participants as possible.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 550
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 550
Exclusion Criteria
- •1. 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.
- •2. 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)
- •3. Previous or current therapy with dolutegravir or bictegravir.
- •4. History of allergy to study drugs or their components.
- •5. Liver disease as defined by ALT=5xULN or ALT=3xULN and Bili
- •=1.5xULN (with >35% direct bilirubin).
- •6. 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);
- •7. Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh classification and/or anticipated need for Hep C treatment.
- •8. Kidney disease as defined by CKD-EPI <50ml/min.
- •9. Any recently (<=6 months) diagnosed clinical condition or recently (<=6 months) initiated concomitant therapy 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 controlled diabetes mellitus.
Investigators
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