A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

A Randomised, Double Blind, Placebo-controlled, Multicenter Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.

Inclusion Criteria:

• Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive.
• Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping essay.

Exclusion Criteria:

• Patients with a CD4 count less than 250 cells/mm3.
• Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for whom there is evidence of recent seroconversion.
• Patients with an HIV viral load less than 5000 copies/ml using RT-PCR(Roche Amplicor v1.5).