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Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
fosamprenavir
COMBIVIR
ritonavir
TRIZIVIR
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring fosamprenavir, ritonavir, COMBIVIR, TRIZIVIR, abacavir, lamivudine, zidovudine, HIV, protease inhibitors

Eligibility Criteria

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

Inclusion Criteria: Lab result for Screening viral load (HIV-1 RNA) greater than or equal to 1,000 copies per mL. Lab result for Screening CD4 cell count greater than or equal to 100 cells per microliter. Antiretroviral therapy naive (no prior therapy allowed). Male or female 13 years of age or older (or 18 years of age or older according to local requirements). Female subjects must be of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including women who are post-menopausal) or of child-bearing potential with a negative blood pregnancy test at screen and who agree to use a proven barrier method of contraception (e.g. spermicide plus condom) during the study period. Hormonal contraceptives will not be considered sufficient forms of contraception for this study. All subjects participating in this study should be counselled on the practice of safe or safer sex. Able to understand and provide written informed consent to participate in this trial. Parental or guardian consent must also be obtained for subjects under the age of 18 years. Exclusion Criteria: Prior history of having received antiretroviral therapy. An active HIV Associated Disease (Center for Disease Control Category C) within 28 days of study drug administration. Any sudden onset or sharp rise in a laboratory abnormality (including abnormally high laboratory values) at Screening that causes the investigator to have the opinion that the subject should not participate in the study of an investigational compound. Subjects with a laboratory result for estimated creatinine clearance less than 40 ml per minute within 28 days of study drug administration. Laboratory result for serum aminotransferase (AST, ALT) levels elevated greater than five to ten times (or more) the upper limit of the normal range within 28 days prior to study drug administration. Pregnant or lactating women. History of clinically relevant pancreatitis or hepatitis within 6 months of study drug administration. Presence of any serious medical condition (e.g., diabetes, cardiac dysfunction, hepatitis) which, in the opinion of the investigator, might compromise the safety of the subject. Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication. History of a drug or other allergy which, in the opinion of the investigator, contraindicates the subject's participation in the study. Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or anticipated need for such treatment during the study. Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days of study drug administration. Treatment with any HIV vaccine within 3 months of study drug administration. Treatment with other selected medications within 28 days prior to receiving study medication or the anticipated need during the study. Current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subject's ability to comply with the requirements of the study. Note: Subjects stabilized on methadone can be considered for participation. Treatment with other investigational drugs or therapies within 28 days prior to Day 1, or an anticipated need for such treatment during the study. Treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis. Other inclusion or exclusion criteria to be determined by the investigator and sponsor of the study.

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

To assess the overall short term tolerance of the regimens under investigation

Secondary Outcome Measures

Nature and incidence of laboratory abnormality; impact/burden of adverse events to subjects; plasma zidovudine (ZDV)pharmacokinetic parameters; change from baseline in plasma HIV-1 RNA levels over time.

Full Information

First Posted
August 14, 2002
Last Updated
February 11, 2013
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00043888
Brief Title
Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR
Official Title
A Phase IIIb/IV, Randomized, Open Label, Multicenter, Pilot Trial to Explore the Safety and Tolerability of GW433908 +/- Ritonavir (1400mg Twice Daily or 700mg/100mg Twice Daily) When Used in Combination With a Zidovudine-containing Regimen (TRIZIVIR or COMBIVIR Twice Daily) Over a 24 Week Period in Antiretroviral Therapy Naive HIV-1 Infected Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of fosamprenavir with or without ritonavir in combination TRIZIVIR and COMBIVIR. Subjects will receive 24 weeks of therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
fosamprenavir, ritonavir, COMBIVIR, TRIZIVIR, abacavir, lamivudine, zidovudine, HIV, protease inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fosamprenavir
Intervention Type
Drug
Intervention Name(s)
COMBIVIR
Intervention Type
Drug
Intervention Name(s)
ritonavir
Intervention Type
Drug
Intervention Name(s)
TRIZIVIR
Primary Outcome Measure Information:
Title
To assess the overall short term tolerance of the regimens under investigation
Secondary Outcome Measure Information:
Title
Nature and incidence of laboratory abnormality; impact/burden of adverse events to subjects; plasma zidovudine (ZDV)pharmacokinetic parameters; change from baseline in plasma HIV-1 RNA levels over time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lab result for Screening viral load (HIV-1 RNA) greater than or equal to 1,000 copies per mL. Lab result for Screening CD4 cell count greater than or equal to 100 cells per microliter. Antiretroviral therapy naive (no prior therapy allowed). Male or female 13 years of age or older (or 18 years of age or older according to local requirements). Female subjects must be of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including women who are post-menopausal) or of child-bearing potential with a negative blood pregnancy test at screen and who agree to use a proven barrier method of contraception (e.g. spermicide plus condom) during the study period. Hormonal contraceptives will not be considered sufficient forms of contraception for this study. All subjects participating in this study should be counselled on the practice of safe or safer sex. Able to understand and provide written informed consent to participate in this trial. Parental or guardian consent must also be obtained for subjects under the age of 18 years. Exclusion Criteria: Prior history of having received antiretroviral therapy. An active HIV Associated Disease (Center for Disease Control Category C) within 28 days of study drug administration. Any sudden onset or sharp rise in a laboratory abnormality (including abnormally high laboratory values) at Screening that causes the investigator to have the opinion that the subject should not participate in the study of an investigational compound. Subjects with a laboratory result for estimated creatinine clearance less than 40 ml per minute within 28 days of study drug administration. Laboratory result for serum aminotransferase (AST, ALT) levels elevated greater than five to ten times (or more) the upper limit of the normal range within 28 days prior to study drug administration. Pregnant or lactating women. History of clinically relevant pancreatitis or hepatitis within 6 months of study drug administration. Presence of any serious medical condition (e.g., diabetes, cardiac dysfunction, hepatitis) which, in the opinion of the investigator, might compromise the safety of the subject. Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication. History of a drug or other allergy which, in the opinion of the investigator, contraindicates the subject's participation in the study. Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or anticipated need for such treatment during the study. Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days of study drug administration. Treatment with any HIV vaccine within 3 months of study drug administration. Treatment with other selected medications within 28 days prior to receiving study medication or the anticipated need during the study. Current alcohol or illicit drug use which, in the opinion of the investigator, may interfere with the subject's ability to comply with the requirements of the study. Note: Subjects stabilized on methadone can be considered for participation. Treatment with other investigational drugs or therapies within 28 days prior to Day 1, or an anticipated need for such treatment during the study. Treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis. Other inclusion or exclusion criteria to be determined by the investigator and sponsor of the study.
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
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
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
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
GSK Clinical Trials Call Center
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
GSK Clinical Trials Call Center
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
GSK Clinical Trials Call Center
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
GSK Clinical Trials Call Center
City
Manchester
ZIP/Postal Code
M8 6RL
Country
United Kingdom

12. IPD Sharing Statement

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Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR

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