Switch to Darunavir/r + Maraviroc QD in Patients With R5 Tropism by Viral DNA Genotyping With Suppressed Viremia (GUSTA): a Multicenter, Open-label, Randomized Controlled Trial

NCT01367210 Phase 4 TERMINATED

Objectives of the study: 1. To verify the safety and the efficacy of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to maraviroc + darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping. 2. To collect relevant information about the safety, the immunologic and the economic impact of this strategy.

Details

Lead sponsor	Catholic University of the Sacred Heart
Phase	Phase 4
Status	TERMINATED
Enrolment	165
Start date	2011-06
Completion	2015-06

Conditions

• HIV Infection

Interventions

• Maraviroc, Darunavir/r
• current antiretroviral therapy with 3 drugs

Primary outcomes

• proportion of patients with virological failure (two consecutive measures of HIV-RNA higher than 50 copies/mL or a single measure higher than 1000 copies/mL) within 48 weeks at per protocol analysis, with switch=failure — 48 weeks

Countries

Italy