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

Condition(s) targeted: HIV Infections

Intervention: Ritonavir (Drug); Abacavir sulfate (Drug); Nelfinavir mesylate (Drug); Lamivudine (Drug); GW433908 (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Glaxo Wellcome

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.

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

Study design: Treatment, Safety Study

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.

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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.

Park Ctr for Health / Keith Vrhel, San Diego, California 92103, United States

AIDS Healthcare Foundation, Los Angeles, California 90027, United States

AIDS Research Alliance, West Hollywood, California 90069, United States

Orange County Ctr for Special Immunology, Fountain Valley, California 92708, United States

LAGLC, Los Angeles, California 90028, United States

Kaiser Hospital, Sacramento, California 95825, United States

Dupont Circle Physicians Group, Washington, District of Columbia 200091104, United States

Univ of Miami Dept of Medicine, Miami, Florida 33136, United States

Infectious Disease Consultants, Altamonte Springs, Florida 32701, United States

Gary Richmond MD, Fort Lauderdale, Florida 33316, United States

CRI of South Florida, Coral Gables, Florida 33146, United States

Therafirst Med Ctr, Fort Lauderdale, Florida 33308, United States

Specialty Med Care Ctrs of South Florida Inc, Miami, Florida 33142, United States

Infectious Diseases Associates, Sarasota, Florida 34239, United States

Infectious Disease Research Inst, Tampa, Florida 33614, United States

Jeffrey Levenson, St. Petersburg, Florida 33710, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States

Med College of Georgia, Augusta, Georgia 30912, United States

SMO USA, Conyers, Georgia 30013, United States

Indiana Univ Med School, Indianapolis, Indiana 46202, United States

Brigham and Women's Hosp, Boston, Massachusetts 02115, United States

Hawthorne Med Associates / PAACA, New Bedford, Massachusetts 02745, United States

Abbott-Northwestern Hosp / Clinic 42, Minneapolis, Minnesota 55404, United States

Southampton Healthcare Inc, St. Louis, Missouri 63139, United States

North Jersey Community Research Initiative, Newark, New Jersey 071032842, United States

VAMC New Jersey Healthcare System, East Orange, New Jersey 07018, United States

SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York 14215, United States

North Shore Univ Hosp, Manhasset, New York 11030, United States

Bronx Veterans Affairs Med Ctr, Bronx, New York 10468, United States

St Lukes - Roosevelt Hosp Ctr, New York, New York 10019, United States

Univ of Cincinnati / Holmes Hosp, Cincinnati, Ohio 452670405, United States

Milton S Hershey Med Ctr, Hershey, Pennsylvania 170330850, United States

Hahnemann Univ Hosp, Philadelphia, Pennsylvania 19102, United States

Burnside Clinic, Columbia, South Carolina 29206, United States

Methodist Healthcare, Memphis, Tennessee 38104, United States

Joseph C Gathe, Houston, Texas 77004, United States

Nicholas Bellos, Dallas, Texas 75246, United States

Starting date: November 2000
Last updated: June 23, 2005