Clinical trial NCT00009061: Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
Lamivudine
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
abacavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 624
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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 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.

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