Back to resultsMonotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GW695634
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring GW695634G, GW695634X, GW678248X, pharmacokinetics, NNRTI, HIV
Eligibility Criteria
Inclusion criteria: CD4 cell count greater than or equal to 200 cells/mm3. HIV-1 RNA >2000 copies/mL. Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine. Normal resting 12-lead electrocardiogram. Exclusion criteria: Any history of seizure, CNS toxoplasmosis infection, or any CNS (central nervous system) lesion. Chronic diarrhea (>3 loose stools/day). An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial. Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1. Any acute laboratory abnormality. Positive for HCV antibody or HepBsAG. Active infections requiring therapy in the previous 4 weeks.
Sites / Locations
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
- GSK Clinical Trials Call Center
Outcomes
Primary Outcome Measures
Safety & tolerability parameters Change from baseline in plasma HIV-1 RNA Change from baseline in CD4+ cell count Plasma GW678248X pharmacokinetic parameters Days 1 & 7
Secondary Outcome Measures
Plasma GW695634X pharmacokinetic parameters on Day 1 and Day 7 Exploratory relationship of pharmacokinetic parameters to changes in virology, immunology and/or safety assessments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00090077
Brief Title
Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults
Official Title
A Phase I, Multicenter, Randomized, Parallel, Double-Blinded Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Dosage Regimens of GW695634G Monotherapy Versus Placebo Over 10 Days in ART-Naive HIV-1 Infected Adults.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
GW695634G, GW695634X, GW678248X, pharmacokinetics, NNRTI, HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW695634
Primary Outcome Measure Information:
Title
Safety & tolerability parameters Change from baseline in plasma HIV-1 RNA Change from baseline in CD4+ cell count Plasma GW678248X pharmacokinetic parameters Days 1 & 7
Secondary Outcome Measure Information:
Title
Plasma GW695634X pharmacokinetic parameters on Day 1 and Day 7 Exploratory relationship of pharmacokinetic parameters to changes in virology, immunology and/or safety assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
CD4 cell count greater than or equal to 200 cells/mm3.
HIV-1 RNA >2000 copies/mL.
Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine.
Normal resting 12-lead electrocardiogram.
Exclusion criteria:
Any history of seizure, CNS toxoplasmosis infection, or any CNS (central nervous system) lesion.
Chronic diarrhea (>3 loose stools/day).
An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial.
Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1.
Any acute laboratory abnormality.
Positive for HCV antibody or HepBsAG.
Active infections requiring therapy in the previous 4 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trial, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
New York
State/Province
New York
ZIP/Postal Code
10008
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults
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