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Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lopinavir/Ritonavir
Ritonavir
GW433908
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, HIV Protease Inhibitors, Ritonavir, RNA, Viral, Anti-HIV Agents, Viral Load, ABT 378, VX-175

Eligibility Criteria

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

Inclusion Criteria Patients may be eligible for this study if they: Have a viral load of 1,000 or more copies/ml. Have taken protease inhibitors (PIs). Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs. Are now taking antiretroviral therapy. Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18. Are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control. Exclusion Criteria Patients will not be eligible for this study if they: Have taken APV or LPV for more than 1 week. Have taken tenofovir disoproxil fumarate (TDF) or adefovir. Have taken more than 2 PIs. Are unable to take 2 active RTIs, as specified by the study. Have an active CDC Category C disease. Have certain abnormal laboratory tests. Are pregnant or breast-feeding. Have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient. Have a history of significant kidney or bone disease. Are not able to take drugs by mouth and cannot absorb them. Have had pancreatitis or hepatitis within the previous 6 months. Have a drug allergy or other allergy which might cause a problem during the study. Have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study. Have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-HIV activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug. Have had any HIV vaccine within 3 months before taking the study drug. Have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study. Use alcohol or illicit drugs in a way that the doctor feels would interfere with the study. Are not able to take the study drugs. Have inadequate kidney function.

Sites / Locations

  • Phoenix Body Positive
  • Ocean View Internal Medicine
  • Bisher Akil
  • Tower ID Med Associates
  • Orange Coast Med Group
  • Pacific Horizons Med Group
  • Denver Inf Disease Consultants
  • Physicans Home Service
  • IDC Research Initiative
  • Bach and Godofsky
  • Community Health Care
  • Therafirst Med Ctr
  • North Broward Hosp District / HIV Clinical Research
  • Florida ID Group
  • Discovery Alliance Inc
  • West Florida Clinical Research Ctr
  • Med College of Georgia
  • Rush Med College / Dept of Infectious Diseases
  • Boston Med Ctr / Evans - 556
  • Abbott-Northwestern Hosp / Clinic 42
  • Southampton Healthcare Inc
  • South Jersey Infectious Diseases Inc
  • ID Care Inc
  • Garden State Infectious Diseases / E I P Kennedy Health Sys
  • Gervais Frechette
  • Duke Univ Med Ctr
  • Summa Health System
  • Fanno Creek Clinic
  • Roger Williams Med Ctr
  • Methodist Healthcare
  • Joseph Gathe
  • Virginia Commonwealth Univ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 15, 2001
Last Updated
June 23, 2005
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00025727
Brief Title
Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure
Official Title
A Phase III, Randomized, Multicenter, Parallel Group, Open-Label, Three Arm Study to Compare the Efficacy and Safety of Two Dosing Regimens of GW433908/Ritonavir (700mg/100mg Twice Daily or 1400mg/200mg Once Daily) Versus Lopinavir/Ritonavir (400mg/100mg Twice Daily) for 48 Weeks in Protease Inhibitor Experienced HIV-Infected Adults Experiencing Virological Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2002
Overall Recruitment Status
Unknown status
Study Start Date
May 2001 (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
The purpose of this study is to test 2 different dosing regimens of GW433908/ritonavir (RTV) versus lopinavir (LPV)/RTV when each is given with 2 active reverse transcriptase inhibitors (RTIs), in patients who have taken anti-HIV drugs without success.
Detailed Description
Patients will receive 2 dosing regimens of GW433908/RTV or LPV/RTV, in combination with 2 active RTIs, after failing their first or second protease inhibitor-containing regimen. Patients are required to be on therapy at time of screening and must remain on this therapy until Day 1.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, HIV Protease Inhibitors, Ritonavir, RNA, Viral, Anti-HIV Agents, Viral Load, ABT 378, VX-175

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
GW433908

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Have a viral load of 1,000 or more copies/ml. Have taken protease inhibitors (PIs). Have taken PI drugs for at least 12 straight weeks and have had virologic failure on the PIs. Are now taking antiretroviral therapy. Are male or female and are at least 13 years old (or 18 if local requirement) and can provide consent from parent or guardian if under 18. Are females unable to have children or, if are able to have children, are not pregnant and agree to use approved birth control. Exclusion Criteria Patients will not be eligible for this study if they: Have taken APV or LPV for more than 1 week. Have taken tenofovir disoproxil fumarate (TDF) or adefovir. Have taken more than 2 PIs. Are unable to take 2 active RTIs, as specified by the study. Have an active CDC Category C disease. Have certain abnormal laboratory tests. Are pregnant or breast-feeding. Have a serious health problem (e.g., diabetes, heart problems, hepatitis) that might risk the safety of the patient. Have a history of significant kidney or bone disease. Are not able to take drugs by mouth and cannot absorb them. Have had pancreatitis or hepatitis within the previous 6 months. Have a drug allergy or other allergy which might cause a problem during the study. Have had radiation or chemotherapy within 28 days of taking the study drug, or expect to need these during the study. Have taken drugs that affect the immune system (corticosteroids, interleukins, interferons) or drugs with anti-HIV activity (hydroxyurea or foscarnet) within 28 days prior to taking the study drug. Have had any HIV vaccine within 3 months before taking the study drug. Have taken certain other drugs within 28 days prior to taking the study drug, or expect to need them during the study. Use alcohol or illicit drugs in a way that the doctor feels would interfere with the study. Are not able to take the study drugs. Have inadequate kidney function.
Facility Information:
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Ocean View Internal Medicine
City
Long Beach
State/Province
California
ZIP/Postal Code
90803
Country
United States
Facility Name
Bisher Akil
City
Los Angeles
State/Province
California
ZIP/Postal Code
90046
Country
United States
Facility Name
Tower ID Med Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Orange Coast Med Group
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Pacific Horizons Med Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Denver Inf Disease Consultants
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Physicans Home Service
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Bach and Godofsky
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Community Health Care
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Therafirst Med Ctr
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
North Broward Hosp District / HIV Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Florida ID Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Discovery Alliance Inc
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
West Florida Clinical Research Ctr
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Rush Med College / Dept of Infectious Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Boston Med Ctr / Evans - 556
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021182393
Country
United States
Facility Name
Abbott-Northwestern Hosp / Clinic 42
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Southampton Healthcare Inc
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Facility Name
South Jersey Infectious Diseases Inc
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
ID Care Inc
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Garden State Infectious Diseases / E I P Kennedy Health Sys
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Gervais Frechette
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Fanno Creek Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Roger Williams Med Ctr
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Methodist Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Joseph Gathe
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Virginia Commonwealth Univ
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure

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