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

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

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.

Study Overview

• Status: Unknown
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Ritonavir; Drug: Lopinavir/Ritonavir; Drug: GW433908

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.

• Study Type: Interventional
• Enrollment: 330
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Phoenix Body Positive
  • California
    • Long Beach, California, United States, 90803
      • Ocean View Internal Medicine
    • Los Angeles, California, United States, 90048
      • Tower ID Med Associates
    • Los Angeles, California, United States, 90046
      • Bisher Akil
    • Newport Beach, California, United States, 92663
      • Orange Coast Med Group
    • San Francisco, California, United States, 94115
      • Pacific Horizons Med Group
  • Colorado
    • Denver, Colorado, United States, 80220
      • Denver Inf Disease Consultants
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Physicans Home Service
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • IDC Research Initiative
    • Bradenton, Florida, United States, 34205
      • Bach and Godofsky
    • Fort Lauderdale, Florida, United States, 33306
      • Community Health care
    • Fort Lauderdale, Florida, United States, 33308
      • Therafirst Med Ctr
    • Fort Lauderdale, Florida, United States, 33311
      • North Broward Hosp District / HIV Clinical Research
    • Orlando, Florida, United States, 32801
      • Florida ID Group
    • Pensacola, Florida, United States, 32503
      • Discovery Alliance Inc
    • Pensacola, Florida, United States, 32514
      • West Florida Clinical Research Ctr
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Med College of Georgia
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Med College / Dept of Infectious Diseases
  • Massachusetts
    • Boston, Massachusetts, United States, 021182393
      • Boston Med Ctr / Evans - 556
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Abbott-Northwestern Hosp / Clinic 42
  • Missouri
    • St. Louis, Missouri, United States, 63139
      • Southampton Healthcare Inc
  • New Jersey
    • Somers Point, New Jersey, United States, 08244
      • South Jersey Infectious Diseases Inc
    • Somerville, New Jersey, United States, 08876
      • ID Care Inc
    • Voorhees, New Jersey, United States, 08043
      • Garden State Infectious Diseases / E I P Kennedy Health Sys
  • New York
    • New York, New York, United States, 10011
      • Gervais Frechette
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Univ Med Ctr
  • Ohio
    • Akron, Ohio, United States, 44304
      • Summa Health System
  • Oregon
    • Portland, Oregon, United States, 97219
      • Fanno Creek Clinic
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Roger Williams Med Ctr
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist Healthcare
  • Texas
    • Houston, Texas, United States, 77004
      • Joseph Gathe
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth Univ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: May 1, 2001

Study Registration Dates

• First Submitted: October 15, 2001
• First Submitted That Met QC Criteria: October 15, 2001
• First Posted (Estimate): October 16, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: June 1, 2002

More Information

Terms related to this study

• Keywords: Anti-HIV Agents; HIV-1; RNA, Viral; Viral Load; HIV Protease Inhibitors; Ritonavir; ABT 378; VX-175
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Lopinavir; Fosamprenavir
• Other Study ID Numbers: 316C