Status:
COMPLETED
Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infection, Human Immunodeficiency Virus
HIV-1 Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00398125
Start Date
November 1 2006
End Date
April 1 2007
Last Update
July 30 2012
Active Locations (12)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35294
2
GSK Investigational Site
Los Angeles, California, United States, 90048
3
GSK Investigational Site
San Diego, California, United States, 92103
4
GSK Investigational Site
San Francisco, California, United States, 94115