NCT00617526

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Ardea Biosciences, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	RDEA806 400 mg
DRUG	Placebo	Placebo
DRUG	RDEA806 1000 mg
DRUG	RDEA806 600 mg
DRUG	RDEA806 800 mg

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-06-01
• Completion: 2008-08-01
• First posted: 2008-02-18
• Last updated: 2014-01-28

Locations

2 sites across 2 countries: Germany, United Kingdom