Back to resultsMonotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
Primary Purpose
Infection, Human Immunodeficiency Virus, HIV-1 Infection
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GSK364735
Sponsored by
About this trial
This is an interventional treatment trial for Infection, Human Immunodeficiency Virus focused on measuring GSK364735, HIV-1, integrase inhibitor
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Change in viral load
Amount of drug in blood
Secondary Outcome Measures
Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00398125
Brief Title
Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
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 Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate safety, tolerability and anti-viral activity in Integrase-Naïve HIV-1 infected adults
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus, HIV-1 Infection
Keywords
GSK364735, HIV-1, integrase inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK364735
Primary Outcome Measure Information:
Title
Change in viral load
Time Frame
from Day 1 to Day 11
Title
Amount of drug in blood
Time Frame
on Days 1 and 10.
Secondary Outcome Measure Information:
Title
Immunologic effect Development of resistance mutations Viral load change and drug levels in semen for a group of patients
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
GSK Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
GSK Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
GSK Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
GSK Investigational Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
12. IPD Sharing Statement
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Monotherapy Versus Placebo Over 10 Days in Integrase Naive HIV-1 Infected Adults
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