Status:
COMPLETED
TMC114-C201: A Study to Determine the Antiviral Activity of TMC114 in Patients With Multiple Protease Inhibitor (PI) Resistant Human Immunodeficiency Virus (HIV) Strains
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the antiviral activity, safety and tolerability of 14 days of different doses of TMC114 to treat HIV-1 positive patients whose condition is failing on a curre...
Detailed Description
This is a Phase lla open-label (all people involved know the identity of the treatment), randomized (study drug assigned by chance), controlled (the patients of the control group continue the failing ...
Eligibility Criteria
Inclusion
- Patient has a documented HIV-1 infection with a viral load at screening visit above 2,000 HIV copies/ml
- Currently treated with a failing antiretroviral regimen consisting of NRTIs together with one or more PI(s)
- Has a resistance against at least 2 of the currently used PIs
- Patient agrees not to change the current therapy until end of run-in and agrees not to change NRTIs until the end of treatment period
- No current AIDS defining illnesses
Exclusion
- NNRTI (non-nucleoside reverse transcriptase inhibitor) containing regimen, two weeks prior to screening
- Suspicion of alcohol abuse or drug abuse, leading to non-compliance
- History of significant drug allergy induced by PIs
- CD4 count \< 50
- Life expectancy of less than 6 months
- Pregnant or breast feeding females
- Females of childbearing potential without use of a highly effective birth control method or not willing to continue practicing this birth control method for at least 14 days after the end of the treatment
- Received an investigational drug within 30 days prior to the trial drug administration
- Patients with clinically significant laboratory abnormalities.
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00964327
Start Date
August 1 2001
End Date
October 1 2003
Last Update
May 19 2011
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