Trials / Terminated
TerminatedNCT01367210
Switch to Darunavir/r + Maraviroc Quaque Die in Patients With R5 Tropism by Viral DNA Genotyping (GUSTA)
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
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- Catholic University of the Sacred Heart · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Maraviroc, Darunavir/r | Maraviroc 300 mg Darunavir 800 mg Ritonavir 100 mg |
| DRUG | current antiretroviral therapy with 3 drugs | To continue the assumption of previous HAART |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2011-06-07
- Last updated
- 2016-02-08
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT01367210. Inclusion in this directory is not an endorsement.