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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: HIV-1 Infection; Infection, Human Immunodeficiency Virus

Treatments: Drug: GSK364735

Study type: Interventional

Funder types: Industry

Identifiers

NCT00398125

GRZ107460

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind