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

Completed · Phase 2

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

In brief

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

Key facts

Study ID

NCT00398125

Run by

GlaxoSmithKline

People needed

30

Starts

2006-11-01

Expected to finish

2007-04-01

Last updated by the study team

2012-07-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — Fort Lauderdale, Florida, United States
• GSK Investigational Site — Hollywood, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Newark, New Jersey, United States
• GSK Investigational Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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