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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00398125
First received: November 8, 2006
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Infection, Human Immunodeficiency Virus
HIV-1 Infection
Drug: GSK364735
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

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

Enrollment: 30
Study Start Date: November 2006
Study Completion Date: April 2007
Intervention Details:
    Drug: GSK364735
    Other Name: GSK364735
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398125

Locations
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
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00398125     History of Changes
Other Study ID Numbers: GRZ107460
Study First Received: November 8, 2006
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GSK364735
HIV-1
integrase inhibitor

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

ClinicalTrials.gov processed this record on September 16, 2014