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

November 8, 2006
July 26, 2012
November 2006
Not Provided
  • Change in viral load [ Time Frame: from Day 1 to Day 11 ]
  • Amount of drug in blood [ Time Frame: on Days 1 and 10. ]
  • Change in viral load from Day 1 to Day 11
  • Amount of drug in blood on Days 1 and 10
Complete list of historical versions of study NCT00398125 on ClinicalTrials.gov Archive Site
Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients [ Time Frame: throughout the study ]
  • Immunologic effect
  • Development of resistance mutations
  • Viral load change and drug levels in semen for a group of patients
Not Provided
Not Provided
 
Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
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.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Infection, Human Immunodeficiency Virus
  • HIV-1 Infection
Drug: GSK364735
Other Name: GSK364735
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2007
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00398125
GRZ107460
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP