Implication for Strategies of Long Term Control of Viral Replication in Patient With Primary HIV Infection (PHI).

Summary

Multicenter, parallel group, randomised, open label, study. Twenty-five clinical centers constituting the InAction network will participate the study. Eligible patients will be randomised in a ratio 10:10:8 to be treated with one of the three antiretroviral regimens: * TDF/FTC 245 mg/200 mg single tablet QD + DRV /cobicistat 800 mg /150 mg single tablet QD (Arm A, standard regimen), * TDF/FTC 245 mg/200 mg single tablet QD + DTG 50 mg QD (Arm B, standard regimen). * TDF/FTC 245 mg/200 mg single tablet QD + DRV 800 mg /cobicistat single tablet QD + DTG 50 mg QD (Arm C, experimental regimen). One-hundred-and-twelve PHI subjects will be recruited for this study among those attending the outpatient Clinic of Infectious Diseases, Ospedale San Raffaele and other Italian centres, involved in the INACTION network.

Timeline

Start

2018-05-07

Primary completion

2019-09-30

Completion

2021-06-14

Publications

• Bruzzesi E, Gabrieli A, Bernasconi D, Marchetti G, Calcagno A, Ripamonti D, Antinori A, Squillace N, Cingolani A, Muscatello A, Bandera A, Gori A, Rusconi S, Nozza S; INACTION Study Group. HIV-DNA decrease during treatment in primary HIV-1 infection with three different drug regimens: Italian Network of Acute HIV Infection (INACTION) clinical trial. J Med Virol. 2023 Sep;95(9):e29114. doi: 10.1002/jmv.29114.

Drugs

Indications