Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults

A Phase I, Multicenter, Randomized, Parallel, Double-Blinded Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Dosage Regimens of GW695634G Monotherapy Versus Placebo Over 10 Days in ART-Naive HIV-1 Infected Adults.

To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients

Inclusion criteria:

• CD4 cell count greater than or equal to 200 cells/mm3.
• HIV-1 RNA >2000 copies/mL.
• Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine.
• Normal resting 12-lead electrocardiogram.

Exclusion criteria:

• Any history of seizure, CNS toxoplasmosis infection, or any CNS (central nervous system) lesion.
• Chronic diarrhea (>3 loose stools/day).
• An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial.
• Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1.
• Any acute laboratory abnormality.
• Positive for HCV antibody or HepBsAG.
• Active infections requiring therapy in the previous 4 weeks.