A Phase IIa Open-label, Randomized Trial to Determine the Antiviral Activity in 60 HIV Positive Subjects With Multiple PI Resistant Strains, Receiving Either Control Treatment or a Daily Dose of 800, 1600, 2400 or 3600 mg TMC114 (Darunavir) for 13 Days Followed by a Single Dose on Day 14
Sponsor study identifier
interventional
42
0 countries
N/A
Study Start
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2003
Actual (reported)Study Completion
October 2003
Actual (reported)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 current treatment regimen that includes a protease inhibitor (PI) (a medication used to reduce the amount of HIV virus in the blood).To be considered for the study, patients must have a documented resistance to at least 2 of the current PIs. Pharmacokinetics and pharmacodynamics of TMC114 will also be assessed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2003
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
October 2003
Actual (reported)October 2003
Actual (reported)July 27, 2009
Actual (reported)August 24, 2009
Actual (reported)To determine the antiviral activity of TMC114.
Screening, days -7, -3, 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 , 15, follow-up weeks 1, 3 and 6
nadir of viral load
Screening, days -7, -3, 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 , 15, follow-up weeks 1, 3 and 6
Pharmacokinetics (PK) / Pharmacodynamics (PD): Plasma concentration of TMC114 and efficacy and safety data will be analyzed to find relationships between PK and PD.
12 visits
CD4 count
7 visits
Tibotec Pharmaceuticals Limited Clinical Trial
Tibotec Pharmaceutical Limited
42 participants (actual enrollment reported by the registry).
First Submitted
July 27, 2009
First Posted
August 24, 2009
Study Start
August 2001
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2003
Actual (reported)Study Completion
October 2003
Actual (reported)Last Updated
May 19, 2011
Record last verified: 2010-04
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Source: ClinicalTrials.gov.
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