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

This study is ongoing, but not recruiting participants.

Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00009061
  Purpose

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.


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

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Abacavir    Abacavir sulfate    Lamivudine    Nelfinavir    Nelfinavir Mesylate    Ritonavir    Fosamprenavir    Fosamprenavir calcium    Fosamprenavir sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   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

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

Estimated Enrollment:   624
Study Start Date:   November 2000

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.

  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 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009061

Show 37 study locations  Show 37 Study Locations

Sponsors and Collaborators
Glaxo Wellcome
  More Information

Study ID Numbers:   316B, APV30002
First Received:   January 23, 2001
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00009061
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  
Ritonavir  
Lamivudine  
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
abacavir

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Fosamprenavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Nelfinavir
Abacavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 29, 2008




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