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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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.