Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults

A Phase 2a, Multicenter, Randomized, Parallel, Double-Blind, Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of GSK364735 Monotherapy Versus Placebo Over 10 Days in HIV-1 Infected Adults.

To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults

Inclusion criteria:

• Documented HIV-1 infection with screening viral load between 5000 and 300,000 copies/mL.
• Baseline CD4 cell count greater than 100.
• Females must be of non-childbearing potential
• Not have received antiretroviral therapy in the 12 weeks prior to first dose.

Exclusion criteria:

• Must not be infected with hepatitis B or C.
• Patients must not have any acute laboratory abnormality.
• Must not have any active CDC (Centers for Disease Control and Prevention)Category C disease (1993), except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial.