Back to resultsGW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
Primary Purpose
Infection, Human Immunodeficiency Virus I, HIV Infection
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GW640385
Ritonavir
Sponsored by
About this trial
This is an interventional treatment trial for Infection, Human Immunodeficiency Virus I focused on measuring HIV-1 protease inhibitor GW640385 ritonavir RTV
Eligibility Criteria
Inclusion criteria: HIV-1 infected subjects. Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception. Plasma HIV-1 RNA (viral load) >/=1,000 copies/mL at Screening. CD4+ cell count >/= 200 cells/mm3 at Screening. Be able to receive at least two of the following NRTIs (3TC, FTC, d4T, ddI or ZDV)to build a nucleoside backbone regimen. Willing and able to provide signed and dated written informed consent prior to study entry. Exclusion criteria: Active CDC Class C disease. Pregnant or breastfeeding women. Protocol-specified laboratory abnormalities at Screening. Personal or family history of autoimmune disease. History or current indication of thyroid dysfunction or current thyroid gland abnormalities.
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
Outcomes
Primary Outcome Measures
Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters.
Secondary Outcome Measures
Changes over time in HIV-1 viral load and CD4+ cell counts. Incidence of adverse events and laboratory abnormalities. GW640385 and RTV PK parameters. Development of resistance in subjects with virologic failure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00257621
Brief Title
GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
Official Title
A Pilot, Phase II, Open-label, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GW640385 When Administered With Ritonavir in Combination With NRTIs for 48 Weeks in HIV-1 Infected Adults
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI) backbone. This study has a 48 week duration and is open to both treatment naive and experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus I, HIV Infection
Keywords
HIV-1 protease inhibitor GW640385 ritonavir RTV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW640385
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Other Intervention Name(s)
GW640385
Primary Outcome Measure Information:
Title
Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters.
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
Changes over time in HIV-1 viral load and CD4+ cell counts. Incidence of adverse events and laboratory abnormalities. GW640385 and RTV PK parameters. Development of resistance in subjects with virologic failure.
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
HIV-1 infected subjects.
Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
Plasma HIV-1 RNA (viral load) >/=1,000 copies/mL at Screening.
CD4+ cell count >/= 200 cells/mm3 at Screening.
Be able to receive at least two of the following NRTIs (3TC, FTC, d4T, ddI or ZDV)to build a nucleoside backbone regimen.
Willing and able to provide signed and dated written informed consent prior to study entry.
Exclusion criteria:
Active CDC Class C disease.
Pregnant or breastfeeding women.
Protocol-specified laboratory abnormalities at Screening.
Personal or family history of autoimmune disease.
History or current indication of thyroid dysfunction or current thyroid gland abnormalities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
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
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20009
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
Orlando
State/Province
Florida
ZIP/Postal Code
32804
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
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
GSK Investigational Site
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
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GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
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