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

HIV-1 Infection Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398125
• Other study ID #: GRZ107460
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2006
• Last updated: July 26, 2012
• Start date: November 2006
• Est. completion date: April 2007

Study information

• Verified date: July 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV-1 Infection
• Immunologic Deficiency Syndromes
• Infection
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• GSK364735

Locations

Country	Name	City	State
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Newark	New Jersey
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in viral load		from Day 1 to Day 11
Primary	Amount of drug in blood		on Days 1 and 10.
Secondary	Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients		throughout the study