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GW873140 In Combination With Combivir In HIV Infected Subjects

Primary Purpose

Infection, Human Immunodeficiency Virus I, HIV Infection

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW873140
Combivir
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infection, Human Immunodeficiency Virus I focused on measuring HIV infections, therapy naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: HIV infected subjects. Females must be of either non-childbearing age, or have a negative pregnancy test. All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study. Screening lab result of plasma HIV-1 RNA greater than or equal to 10,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3. Have CC Chemokine Receptor5-tropic (R5-tropic) virus based on viral tropism test at screening visit. Have no drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit. Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or a nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI). Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed. Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions. Signed and dated written informed consent prior to study entry. Exclusion criteria: Detection of any CXC Receptor4-tropic (X4-tropic) virus, based on viral tropism test at screening. Any drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit. Active Class C AIDS-defining illness. Laboratory abnormalities at screen. Significant blood loss prior to study start. Pregnant or breastfeeding women. Additional qualifying criteria to be determined by the physician.

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
  • 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
  • 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
  • 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
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12

Secondary Outcome Measures

- Comparison of safety and tolerability of different dosage regimens of GW873140 plus Combivir to standard of care regimen. - Assessment of drug resistance over time. - Co-receptor tropism following virological failure.

Full Information

First Posted
February 28, 2005
Last Updated
May 25, 2017
Sponsor
ViiV Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00104429
Brief Title
GW873140 In Combination With Combivir In HIV Infected Subjects
Official Title
A PhaseIIb, 96 Week, Randomised, Partially Double-blinded, Multicentre, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of GW873140 in Combination With COMBIVIR (Lamivudine and Zidovudine) Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy Naive Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare

4. Oversight

5. Study Description

Brief Summary
This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir in HIV infected, untreated subjects.
Detailed Description
A Phase IIb, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with Combivir (lamivudine and zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults

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 infections, therapy naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW873140
Intervention Type
Drug
Intervention Name(s)
Combivir
Other Intervention Name(s)
GW873140
Primary Outcome Measure Information:
Title
Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12
Secondary Outcome Measure Information:
Title
- Comparison of safety and tolerability of different dosage regimens of GW873140 plus Combivir to standard of care regimen. - Assessment of drug resistance over time. - Co-receptor tropism following virological failure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: HIV infected subjects. Females must be of either non-childbearing age, or have a negative pregnancy test. All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study. Screening lab result of plasma HIV-1 RNA greater than or equal to 10,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3. Have CC Chemokine Receptor5-tropic (R5-tropic) virus based on viral tropism test at screening visit. Have no drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit. Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or a nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI). Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed. Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions. Signed and dated written informed consent prior to study entry. Exclusion criteria: Detection of any CXC Receptor4-tropic (X4-tropic) virus, based on viral tropism test at screening. Any drug resistance mutations in HIV-1 Reverse Transcriptase based on resistance test at screening visit. Active Class C AIDS-defining illness. Laboratory abnormalities at screen. Significant blood loss prior to study start. Pregnant or breastfeeding women. Additional qualifying criteria to be determined by the physician.
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
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
GSK Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
GSK Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
GSK Investigational Site
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
GSK Investigational Site
City
Tarzana
State/Province
California
ZIP/Postal Code
30342
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
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
Miami
State/Province
Florida
ZIP/Postal Code
33136
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
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
GSK Investigational Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
GSK Investigational Site
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30013
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
GSK Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
GSK Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
GSK Investigational Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
7102
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10008
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14604
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
GSK Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75215
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
GSK Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1N 6N5
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 5B1
Country
Canada
Facility Name
GSK Investigational Site
City
Levallois-Perret
ZIP/Postal Code
92300
Country
France
Facility Name
GSK Investigational Site
City
Lyon Cedex 02
ZIP/Postal Code
69288
Country
France
Facility Name
GSK Investigational Site
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
GSK Investigational Site
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
GSK Investigational Site
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25125
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20127
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20157
Country
Italy
Facility Name
GSK Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
GSK Investigational Site
City
Lisboa
ZIP/Postal Code
1169-100
Country
Portugal
Facility Name
GSK Investigational Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
GSK Investigational Site
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Brighton
State/Province
Sussex East
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Warwickshire
ZIP/Postal Code
B29 6JD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
EC1 7BE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SW10 9TH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

GW873140 In Combination With Combivir In HIV Infected Subjects

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