A Multicenter Phase 2a, Randomized, Double-blind, Placebo-controlled, Proof-of-concept Trial to Determine the Antiviral Activity, Pharmacokinetics, Tolerability and Safety of RDEA806 in HIV-1 Positive, Antiretroviral naïve Subjects
Sponsor study identifier
interventional
48
2 countries
2
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
August 2008
Actual (reported)The primary objective of the trial is:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 6, 2008
Actual (reported)February 18, 2008
Actual (reported)June 2008
Actual (reported)August 2008
Actual (reported)Change from baseline in HIV plasma viral load
9 days
Safety will be assessed as adverse and HIV related events, clinical laboratory test results(hematology, chemistry, urinalysis), vital signs, 12-lead electrocardiograms (ECGs), and physical examination
22 days
Pharmacokinetics and Resistance
22 days
Placebo or RDEA806 400 mg twice daily (BID) for 7 days and a single morning dose on Day 8.
Placebo or RDEA806 600 mg once daily (QD) for 7 days with an additional dose on the morning of Day 8.
Placebo
Hamburg, 20099, Germany
London, SW109NH, United Kingdom
Moyle G, Boffito M, Stoehr A, Rieger A, Shen Z, Manhard K, Sheedy B, Hingorani V, Raney A, Nguyen M, Nguyen T, Ong V, Yeh LT, Quart B. Phase 2a randomized controlled trial of short-term activity, safety, and pharmacokinetics of a novel nonnucleoside reverse transcriptase inhibitor, RDEA806, in HIV-1-positive, antiretroviral-naive subjects. Antimicrob Agents Chemother. 2010 Aug;54(8):3170-8. doi: 10.1128/AAC.00268-10. Epub 2010 May 24.
Vijay Hingorani, MD, PhD
Ardea Biosciences
48 participants (actual enrollment reported by the registry).
First Submitted
February 6, 2008
First Posted
February 18, 2008
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Repeated DermaVir Immunizations in HIV-1 Infected Treatment-naïve Patients
Placebo or RDEA806 800 mg QD using enteric coated tablets for 7 days with an additional morning dose on Day 8.
Placebo or RDEA806 1000 mg QD using enteric coated tablets for 7 days with an additional dose on the morning of Day 8.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 2008
Actual (reported)Study Completion
August 2008
Actual (reported)Last Updated
January 28, 2014
Record last verified: 2013-12
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Source: ClinicalTrials.gov.
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