Switching the Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) or Protease Inhibitor (PI) to Maraviroc in HIV Subjects
NCT00966329 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2013-01-24
Summary
Patients with HIV-1 infection on HAART regimen including 2 NRTI/NtRTIs plus one of the following : 1 PI/ritonavir or ATV/unboosted or 1 NNRTI, will be randomized to switch from the NNRTI/PI to maraviroc (300 mg /12 h) or to continue with the same approach.
Conditions
- HIV
- HIV Infections
Interventions
- DRUG
-
maraviroc
HAART regimen including 2 NRTI/NtRTIs plus maraviroc
- DRUG
-
control group
HAART regimen including 2 NRTI/NtRTIs plus one of the following : * 1 PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir /ritonavir, tipranavir/ritonavir, darunavir/ritonavir) * or ATV/unboosted (in a regimen without tenofovir) * or 1 NNRTI (nevirapine or efavirenz).
Sponsors & Collaborators
-
Germans Trias i Pujol Hospital
lead OTHER
Principal Investigators
-
Eugènia Negredo, MD,PhD · Lluita contra la Sida Foundation, HIV Unit
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2012-05-31
- Completion
- 2012-05-31
Countries
- Spain
Study Locations
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