Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy

June 23, 2005 updated by: Glaxo Wellcome

A Phase III, Randomised, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of GW433908 (1400 Mg Bid) and Nelfinavir (1250 Mg Bid) Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults

The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized in a 2:1 scheme to 1 of 2 treatment groups. Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC. Patients undergo safety and efficacy assessments at the Screening Visit, Day 1 (Entry), and Weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter. A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug. Detailed assessments for the development of lipodystrophy/fat redistribution occur at Day 1, Week 24, Week 48, and every 16 weeks thereafter. Patients have examinations and laboratory tests performed at visits.

Study Type

Interventional

Enrollment

210

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
      • Concord, California, United States, 94520
        • East Bay Clinical Trial Ctr
      • Long Beach, California, United States, 90803
        • Ocean View Internal Medicine
    • Florida
      • Orlando, Florida, United States, 32801
        • Florida ID Group
      • Tampa, Florida, United States, 33617
        • Clinical Pharmacology Services
      • Tampa, Florida, United States, 33602
        • Hillsborough County Health Dept
    • Illinois
      • Chicago, Illinois, United States, 60064
        • Veterans Affairs Med Ctr of North Chicago
    • Kansas
      • Kansas City, Kansas, United States, 661607415
        • Univ of Kansas Med Ctr
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Med Ctr
      • Newark, New Jersey, United States, 071032757
        • UMDNJ - New Jersey Med School
    • New York
      • Bronx, New York, United States, 10461
        • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
      • Brooklyn, New York, United States, 112123198
        • Brookdale Univ Hosp and Med Ctr
      • Brooklyn, New York, United States, 11201
        • Addiction Research and Treatment Corp
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10011
        • Howard Grossman
      • New York, New York, United States, 10011
        • Gervais Frechette
      • Rochester, New York, United States, 14642
        • Univ of Rochester Med Ctr
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • SMO-USA Inc
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Advanced Clinical Trials Inc
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson Univ
    • Texas
      • Galveston, Texas, United States, 775550835
        • Univ of Texas Med Branch
      • Houston, Texas, United States, 77054
        • MacGregor Med Association
      • Irving, Texas, United States, 75038
        • Walter Gaman
      • San Antonio, Texas, United States, 78229
        • Southwest Texas Methodist Hosp

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 required 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 (NNRT) or protease inhibitor (PI).
  • Have a viral load (amount of HIV in the blood) of 5,000 copies/ml or more, or have a positive result at the screening visit.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Abuse drugs or alcohol in a way that would interfere with the study, in the opinion of the doctor. Patients stable on methadone will be considered for participation.
  • 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 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
  • Interventional Model: Parallel Assignment

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 13, 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

July 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 316A
  • APV30001

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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