Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs

June 23, 2005 updated by: Glaxo Wellcome

A Randomized, Open-Label, Two Arm Trial to Compare the Safety and Antiviral Efficacy of GW433908/Ritonavir QD to Nelfinavir BID When Used in Combination With Abacavir and Lamivudine for 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Subjects

The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.

Study Type

Interventional

Enrollment

624

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Orange County Ctr for Special Immunology
      • Los Angeles, California, United States, 90027
        • AIDS Healthcare Foundation
      • Los Angeles, California, United States, 90028
        • LAGLC
      • Sacramento, California, United States, 95825
        • Kaiser Hospital
      • San Diego, California, United States, 92103
        • Park Ctr for Health / Keith Vrhel
      • West Hollywood, California, United States, 90069
        • AIDS Research Alliance
    • District of Columbia
      • Washington, District of Columbia, United States, 200091104
        • Dupont Circle Physicians Group
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Infectious Disease Consultants
      • Coral Gables, Florida, United States, 33146
        • CRI of South Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Gary Richmond MD
      • Fort Lauderdale, Florida, United States, 33308
        • Therafirst Med Ctr
      • Miami, Florida, United States, 33142
        • Specialty Med Care Ctrs of South Florida Inc
      • Miami, Florida, United States, 33136
        • Univ of Miami Dept of Medicine
      • Sarasota, Florida, United States, 34239
        • Infectious Diseases Associates
      • St. Petersburg, Florida, United States, 33710
        • Jeffrey Levenson
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Inst
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
      • Augusta, Georgia, United States, 30912
        • Med College of Georgia
      • Conyers, Georgia, United States, 30013
        • SMO USA
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ Med School
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hosp
      • New Bedford, Massachusetts, United States, 02745
        • Hawthorne Med Associates / PAACA
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Abbott-Northwestern Hosp / Clinic 42
    • Missouri
      • St. Louis, Missouri, United States, 63139
        • Southampton Healthcare Inc
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • VAMC New Jersey Healthcare System
      • Newark, New Jersey, United States, 071032842
        • North Jersey Community Research Initiative
    • New York
      • Bronx, New York, United States, 10468
        • Bronx Veterans Affairs Med Ctr
      • Buffalo, New York, United States, 14215
        • SUNY / Erie County Med Ctr at Buffalo
      • Manhasset, New York, United States, 11030
        • North Shore Univ Hosp
      • New York, New York, United States, 10019
        • St Lukes - Roosevelt Hosp Ctr
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Univ of Cincinnati / Holmes Hosp
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 170330850
        • Milton S Hershey Med Ctr
      • Philadelphia, Pennsylvania, United States, 19102
        • Hahnemann Univ Hosp
    • South Carolina
      • Columbia, South Carolina, United States, 29206
        • Burnside Clinic
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist Healthcare
    • Texas
      • Dallas, Texas, United States, 75246
        • Nicholas Bellos
      • Houston, Texas, United States, 77004
        • Joseph C Gathe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Are at least 13 years old (consent of parent or guardian needed if under 18).
  • Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
  • Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI). Mothers who have previously received 1 dose of the NNRTI nevirapine during pregnancy for prevention of mother-to-child HIV transmission are permitted to enter the study.
  • Have a viral load (amount of HIV in the blood) of 1,000 copies/ml or more.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Abuse drugs or alcohol in a way that would interfere with study requirements. Patients who are stable on methadone will be considered for the study.
  • Have an active/acute CDC Category C event.
  • Are unable to absorb or take medicines by mouth.
  • Are pregnant or breast-feeding.
  • Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
  • Have had pancreatitis or hepatitis within the last 6 months.
  • Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.
  • Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.
  • Have received an HIV vaccine within 3 months before the study drug will be taken.
  • Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.
  • Have received experimental treatments.
  • Have allergies which might interfere with the study, in the opinion of the doctor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Study Registration Dates

First Submitted

January 23, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 316B
  • APV30002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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