HIV-1 RNA decay in semen and rectum and changes in HIV reservoir in rectal tissue in ART-naïve HIV+ men treated with dolutegravir plus lamivudine compared to Bictegravir/FTC/TAF (DOLLARS study”)

Daniel Podzamczer Palter0 sites24 target enrollmentStarted: December 2, 2019Last updated: February 1, 2020

Conditions

Drugs

Trial Snapshot

No summary available.

•1. HIV-1 infected male and female = 18 years of age.
•2. Not previously exposed to ART
•3. Plasma viral load (HIV-1 RNA) at screening >1.000 copies/mL
•4. Plasma viral load (HIV-1 RNA) <500,000 copies/mL and CD4+ T lymphocytes count at screening >200 cells/µL at screening
•5. Signed and dated written informed consent prior to inclusion.
•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 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Plasma viral load (HIV-1 RNA) at screening >500,000 copies/mL
•2. CD4+ T lymphocytes count at screening <200 cells/µL
•3. Hepatitis B virus (HBV)
•4. Severe hepatic impairment (Child-Pugh Class C)
•5. Ongoing malignancy
•6. Active opportunistic infection
•7. Primary resistance to the study ARV drugs.
•8. Ongoing therapy with any significant interaction with the study drugs.
•9. Any verified Grade 4 laboratory abnormality
•10. ALT or AST = 3xULN and/or bilirubin = 1.5xULN
•11. Renal function impairment, defined as an estimated glomerular filtration rate < 50 mL/min
•12. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.

Sponsor

Daniel Podzamczer Palter