TMC114-C213: A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose-response of TMC114/RTV in 3-class-experienced HIV-1 Infected Patients, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV.
NCT00650832 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 334
Last updated 2011-06-15
Summary
The purpose of this study is to determine the antiviral activity, safety and tolerability of TMC114, formulated as an oral tablet, and administered with a low dose of ritonavir
Conditions
Interventions
- DRUG
-
TMC114; darunavir; Prezista
Sponsors & Collaborators
-
Tibotec Pharmaceuticals, Ireland
lead INDUSTRY
Principal Investigators
-
Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-10-31
- Primary Completion
- 2005-02-28
- Completion
- 2007-07-31
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