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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00008554
First received: January 13, 2001
Last updated: June 23, 2005
Last verified: July 2001
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Abacavir sulfate
Drug: Nelfinavir mesylate
Drug: Lamivudine
Drug: GW433908
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 210
Study Start Date: November 2000
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008554

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

No publications provided

ClinicalTrials.gov Identifier: NCT00008554     History of Changes
Other Study ID Numbers: 316A, APV30001
Study First Received: January 13, 2001
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Lamivudine
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
abacavir

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Abacavir
Fosamprenavir
Lamivudine
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014