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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00009061
• Other study ID #: 316B
• Secondary ID: APV30002
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 23, 2001
• Last updated: June 23, 2005
• Start date: November 2000

Study information

• Verified date: March 2002
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 624
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Ritonavir

• Abacavir sulfate

• Nelfinavir mesylate

• Lamivudine

• GW433908

Locations

Country	Name	City	State
United States	Infectious Disease Consultants	Altamonte Springs	Florida
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Med College of Georgia	Augusta	Georgia
United States	Brigham and Women's Hosp	Boston	Massachusetts
United States	Bronx Veterans Affairs Med Ctr	Bronx	New York
United States	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York
United States	Univ of Cincinnati / Holmes Hosp	Cincinnati	Ohio
United States	Burnside Clinic	Columbia	South Carolina
United States	SMO USA	Conyers	Georgia
United States	CRI of South Florida	Coral Gables	Florida
United States	Nicholas Bellos	Dallas	Texas
United States	VAMC New Jersey Healthcare System	East Orange	New Jersey
United States	Gary Richmond MD	Fort Lauderdale	Florida
United States	Therafirst Med Ctr	Fort Lauderdale	Florida
United States	Orange County Ctr for Special Immunology	Fountain Valley	California
United States	Milton S Hershey Med Ctr	Hershey	Pennsylvania
United States	Joseph C Gathe	Houston	Texas
United States	Indiana Univ Med School	Indianapolis	Indiana
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	LAGLC	Los Angeles	California
United States	North Shore Univ Hosp	Manhasset	New York
United States	Methodist Healthcare	Memphis	Tennessee
United States	Specialty Med Care Ctrs of South Florida Inc	Miami	Florida
United States	Univ of Miami Dept of Medicine	Miami	Florida
United States	Abbott-Northwestern Hosp / Clinic 42	Minneapolis	Minnesota
United States	Hawthorne Med Associates / PAACA	New Bedford	Massachusetts
United States	St Lukes - Roosevelt Hosp Ctr	New York	New York
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Hahnemann Univ Hosp	Philadelphia	Pennsylvania
United States	Kaiser Hospital	Sacramento	California
United States	Park Ctr for Health / Keith Vrhel	San Diego	California
United States	Infectious Diseases Associates	Sarasota	Florida
United States	Southampton Healthcare Inc	St. Louis	Missouri
United States	Jeffrey Levenson	St. Petersburg	Florida
United States	Infectious Disease Research Inst	Tampa	Florida
United States	Dupont Circle Physicians Group	Washington	District of Columbia
United States	AIDS Research Alliance	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,