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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398125
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : July 30, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus HIV-1 Infection Drug: GSK364735 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : November 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Change in viral load [ Time Frame: from Day 1 to Day 11 ]
  2. Amount of drug in blood [ Time Frame: on Days 1 and 10. ]

Secondary Outcome Measures :
  1. Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients [ Time Frame: throughout the study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00398125

United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90048
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
San Francisco, California, United States, 94115
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80220
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Hollywood, Florida, United States, 33020
GSK Investigational Site
Orlando, Florida, United States, 32803
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30308
United States, New Jersey
GSK Investigational Site
Newark, New Jersey, United States, 07102
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00398125     History of Changes
Other Study ID Numbers: GRZ107460
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by GlaxoSmithKline:
integrase inhibitor

Additional relevant MeSH terms:
Communicable Diseases
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases