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

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

Drug Information available for: Lamivudine Abacavir Ritonavir Nelfinavir Nelfinavir Mesylate Abacavir sulfate Fosamprenavir Fosamprenavir sodium Fosamprenavir calcium

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

Sponsors and Collaborators

Glaxo Wellcome

More Information

No publications provided

Study ID Numbers:	316B, APV30002
Study First Received:	January 23, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00009061 History of Changes
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:

HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Lamivudine
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Reverse Transcriptase Inhibitors

Virus Diseases
Anti-Retroviral Agents
Fosamprenavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Abacavir
Nelfinavir
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Abacavir
Nelfinavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
RNA Virus Infections

Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Fosamprenavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 06, 2009