HIV infection MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: TIVICAY
Pharmaceutical Form: Tablet
INN or Proposed INN: DOLUTEGRAVIR SODIUM
CAS Number: 1051375-16-6
Other descriptive name
Sponsors
Daniel Podzamczer Palter
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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) 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare HIV-1 RNA decay kinetics in semen in ART-naïve HIV-1 infected male individuals treated with DTG/3TC dual therapy versus BIC/FTC/TAF.;Secondary Objective: To compare HIV-1 RNA decay kinetics in rectal fluid in ART-naïve HIV-1 infected male individuals treated with DTG/3TC dual therapy versus BIC/FTC/TAF.; Primary end point(s): HIV-1 RNA decay in seminal plasma from baseline and up to 24 weeks after initiation of DTG/3TC vs Bictegravir/FTC/TAF. HIV-1 RNA decay in rectal fluid from baseline and up to 24 weeks after initiation of DTG/3TC vs Bictegravir/FTC/TAF. ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): HIV-1 RNA decay in blood plasma from baseline and up to 24 weeks after initiation of DTG/3TC vs Bictegravir/FTC/TAF.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Spain
Contacts
Public ContactUnidad de VIH e ITS
Hospital Universitari de Bellvitge
Outcome results
None listed