Naïve HIV POC Monotherapy Trial

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

Timeline

Start

2008-01

Primary completion

2008-06

Completion

2008-08

Publications

• 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.

Drugs

Indications