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

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

Patrocinadores

Patrocinador principal: Glaxo Wellcome

Fuente NIH AIDS Clinical Trials Information Service
Resumen breve

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.

Descripción detallada

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.

Estado general Unknown status
Fecha de inicio November 2000
Fase Phase 3
Tipo de estudio Interventional
Inscripción 624
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Ritonavir

Tipo de intervención: Drug

Nombre de intervención: Abacavir sulfate

Tipo de intervención: Drug

Nombre de intervención: Nelfinavir mesylate

Tipo de intervención: Drug

Nombre de intervención: Lamivudine

Tipo de intervención: Drug

Nombre de intervención: GW433908

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 13 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
Orange County Ctr for Special Immunology | Fountain Valley, California, 92708, United States
AIDS Healthcare Foundation | Los Angeles, California, 90027, United States
LAGLC | Los Angeles, California, 90028, United States
Kaiser Hospital | Sacramento, California, 95825, United States
Park Ctr for Health / Keith Vrhel | San Diego, California, 92103, United States
AIDS Research Alliance | West Hollywood, California, 90069, United States
Dupont Circle Physicians Group | Washington, District of Columbia, 200091104, United States
Infectious Disease Consultants | Altamonte Springs, Florida, 32701, United States
CRI of South Florida | Coral Gables, Florida, 33146, United States
Therafirst Med Ctr | Fort Lauderdale, Florida, 33308, United States
Gary Richmond MD | Fort Lauderdale, Florida, 33316, United States
Univ of Miami Dept of Medicine | Miami, Florida, 33136, United States
Specialty Med Care Ctrs of South Florida Inc | Miami, Florida, 33142, United States
Infectious Diseases Associates | Sarasota, Florida, 34239, United States
Jeffrey Levenson | St. Petersburg, Florida, 33710, United States
Infectious Disease Research Inst | Tampa, Florida, 33614, 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
VAMC New Jersey Healthcare System | East Orange, New Jersey, 07018, United States
North Jersey Community Research Initiative | Newark, New Jersey, 071032842, United States
Bronx Veterans Affairs Med Ctr | Bronx, New York, 10468, 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
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
Nicholas Bellos | Dallas, Texas, 75246, United States
Joseph C Gathe | Houston, Texas, 77004, United States
Ubicacion Paises

United States

Fecha de verificación

March 2002

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Propósito primario: Treatment

Fuente: ClinicalTrials.gov