Naïve HIV POC Monotherapy Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00617526
First received: February 6, 2008
Last updated: December 20, 2013
Last verified: December 2013

February 6, 2008
December 20, 2013
January 2008
June 2008   (final data collection date for primary outcome measure)
Change from baseline in HIV plasma viral load [ Time Frame: 9 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00617526 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 22 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics and Resistance [ Time Frame: 22 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Naïve HIV POC Monotherapy Trial
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

The primary objective of the trial is:

• to evaluate the change from baseline in plasma viral load with placebo and one of up to 4 dose regimens of RDEA806.

The secondary objectives are:

Efficacy

  • to describe the nadir of the plasma viral load
  • to describe the DAVG
  • to assess the proportion of subjects who reached a drop in viral load of 0.5 log, 1 log, or reach an undetectable viral load
  • to assess the plasma viral load decay rate
  • to evaluate immunologic changes (as measured by CD4 and CD8 cells)
  • to evaluate the genotypic and phenotypic pattern of the virus Pharmacokinetics
  • to evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of RDEA806 Safety
  • to evaluate the safety and tolerability of bid and qd dosing of RDEA806 as monotherapy
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: RDEA806 400 mg
  • Drug: Placebo
    Placebo
  • Drug: RDEA806 1000 mg
  • Drug: RDEA806 600 mg
  • Drug: RDEA806 800 mg
  • Experimental: RDEA806 400 mg
    Placebo or RDEA806 400 mg twice daily (BID) for 7 days and a single morning dose on Day 8.
    Interventions:
    • Drug: RDEA806 400 mg
    • Drug: Placebo
  • Experimental: RDEA806 600 mg
    Placebo or RDEA806 600 mg once daily (QD) for 7 days with an additional dose on the morning of Day 8.
    Interventions:
    • Drug: Placebo
    • Drug: RDEA806 600 mg
  • Experimental: RDEA806 800 mg
    Placebo or RDEA806 800 mg QD using enteric coated tablets for 7 days with an additional morning dose on Day 8.
    Interventions:
    • Drug: Placebo
    • Drug: RDEA806 800 mg
  • Experimental: RDEA806 1000 mg
    Placebo or RDEA806 1000 mg QD using enteric coated tablets for 7 days with an additional dose on the morning of Day 8.
    Interventions:
    • Drug: Placebo
    • Drug: RDEA806 1000 mg
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented chronic HIV-1 infection
  • HIV-1 plasma viral load at screening visit above 5000 HIV-1 RNA copies/ml
  • Male, aged above 18 years and less than 65 years of age
  • Adequate method of birth control
  • Subject has never received an antiretroviral agent (NRTI, NNRTI, PI, entry inhibitor or integrase inhibitor) for the treatment of HIV and agrees not to start antiretroviral therapy prior to enrollment or subject has only received a short course of treatment for less than 14 days and has been off treatment for at least 8 weeks
  • Subject has no primary mutation in the reverse transcriptase (RT) gene associated with resistance to RT inhibitors and no major mutation in the protease gene associated with resistance to PIs determined by genotypic resistance testing at screening

Exclusion Criteria:

  • History or suspicion of alcohol or drug abuse which in the Investigator's opinion may lead to non-compliance
  • CD4 count < 350 cells/mm3
  • Life expectancy of less than 6 months
  • Receipt of an investigational drug within 30 days prior to the trial drug administration
  • Receipt of any vaccine within 30 days of screening visit
  • Acute HIV-1 infection (seroconversion illness)
  • Acute hepatitis A or acute or chronic hepatitis B or C infection
  • Currently active acquired immune deficiency syndrome (AIDS)-defining illness (Category C conditions according to the Centers for Disease Control [CDC] Classification System for HIV Infection 1993)
  • No clinically relevant laboratory abnormalities Renal impairment: serum creatinine > 1.5 x ULN
  • Febrile illness within 120 hours prior to dosing
  • History of severe drug allergy or hypersensitivity
  • Significant cardiac dysfunction
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United Kingdom
 
NCT00617526
RDEA806-201
No
Ardea Biosciences, Inc.
Ardea Biosciences, Inc.
Not Provided
Study Director: Vijay Hingorani, MD, PhD Ardea Biosciences
Ardea Biosciences, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP