Naïve HIV POC Monotherapy Trial
This study has been completed.
Ardea Biosciences, Inc.
Information provided by (Responsible Party):
Ardea Biosciences, Inc.
First received: February 6, 2008
Last updated: October 29, 2013
Last verified: October 2013
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:
- 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
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Ardea Biosciences, Inc.:
Primary Outcome Measures:
- Change from baseline in HIV plasma viral load [ Time Frame: 9 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
|Study Start Date:||January 2008|
|Study Completion Date:||August 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Subjects in Cohort 1 will receive a bid dose of RDEA806 400 mg for 7 consecutive days followed by a single dose on Day 8. In Cohort 2, subjects will receive a qd dose of RDEA806 600 mg for 7 consecutive days, with an additional dose on Day 8. All subjects will be followed for 2 weeks after the last dose. Cohorts 3 and 4: Study medication will be supplied as RDEA806 Enteric Coated Tablets, 200 mg. Each tablet is a white, film-coated, oval-shaped tablet that weighs approximately 299 mg and contains 200 mg RDEA806. Cohorts 3 and 4 will be dosed with 800 mg qd and 1,000 mg qd (or 400 mg bid), respectively. Subjects in Cohorts 3 and 4 will take the RDEA806 Over-Encapsulated Capsule with 240 mL (approximately 8 ounces) of ambient-temperature water. Subjects will be dosed approximately 30 minutes following breakfast (or approximately 30 minutes following breakfast and dinner in the 400 mg bid dose).
|Placebo Comparator: b||
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