Clinical trial NCT00004583: A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy
Official title: A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Administration, Oral
Stavudine
HIV Protease Inhibitors
Lamivudine
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Nelfinavir
ABT 378
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 660
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).

Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.

Detailed description: Based on the accumulated studies to date, it is expected that ABT-378/ritonavir will provide efficacy that is at least as good as (or superior to) nelfinavir when used in combination with reverse transcriptase inhibitors.

Patients are equally randomized to one of two treatment arms. In one arm, approximately 330 patients receive ABT-378/ritonavir plus nelfinavir placebo. In the other arm, approximately 330 patients receive nelfinavir plus ABT-378/ritonavir placebo. In both arms, these protease inhibitors are blinded to the investigator, patient, and sponsor. Both arms receive open-label stavudine and lamivudine. Vital sign measurements, physical examinations, ECGs, routine clinical laboratory evaluations, and determinations of antiviral and immunologic activity are performed at intervals throughout the study.

Eligibility criteria: Inclusion Criteria

You may be eligible for this trial if you:

* Are HIV positive.
* Have a viral load (level of HIV in your blood) of more than 400 copies/ml.
* Are age 12 or older.
* Agree to practice abstinence or use effective methods of birth control during the study.

Exclusion Criteria

You will not be eligible for this trial if you:

* Have taken anti-HIV drugs for more than 14 days in the past, or if you have ever taken d4T or 3TC.
* Are seriously ill or have an AIDS-related infection.
* Are pregnant or breast-feeding.
* Are taking certain medications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pacific Oaks Med Group
state: California
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: Tower ID Med Associates
state: California
city: Los Angeles
country: United States
facility: UCLA CARE Ctr
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Administration Med Ctr
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Med Ctr
state: California
city: New Haven
country: United States
facility: Yale Univ / AIDS Clinical Trials Unit
state: Connecticut
city: Miami
country: United States
facility: Steinhart Medical Associates
state: Florida
city: Miami
country: United States
facility: Univ of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Emory Univ
state: Georgia
city: Chicago
country: United States
facility: AIDS Research Alliance - Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Division of Inf Diseases/ Indiana Univ Hosp
state: Indiana
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: New Orleans
country: United States
facility: Tulane Univ Med School
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: Boston
country: United States
facility: Boston Med Ctr
state: Massachusetts
city: Brookline
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: Ann Arbor
country: United States
facility: Univ of Michigan Hospitals and Health Ctrs
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hosp
state: Minnesota
city: East Orange
country: United States
facility: East Orange Veterans Administration Med Ctr
state: New Jersey
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
city: New York
country: United States
facility: Cornell Clinical Trials Unit - Chelsea Clinic
state: New York
city: New York
country: United States
facility: Howard Grossman
state: New York
city: Stony Brook
country: United States
facility: SUNY at Stony Brook / Div of Infectious Disease
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr / Infectious Disease Clinic
state: North Carolina
city: Cincinnati
country: United States
facility: Holmes Hosp / Univ of Cincinnati Med Ctr
state: Ohio
city: Tulsa
country: United States
facility: Associates in Med and Mental Health
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health Sciences Univ
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Philadelphia
country: United States
facility: Stephen Hauptman
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hosp
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr
state: Tennessee
city: Austin
country: United States
facility: Central Texas Med Foundation
state: Texas
city: Dallas
country: United States
facility: Oaklawn Physicians Group
state: Texas
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr
state: Texas
city: Houston
country: United States
facility: Joseph C Gathe
state: Texas
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
city: Charlottesville
country: United States
facility: Univ of Virginia Health Sciences Ctr
state: Virginia
city: Madison
country: United States
facility: Univ of Wisconsin
state: Wisconsin
city: Herston
country: Australia
facility: Royal Brisbane Hosp
city: Perth
country: Australia
facility: Royal Perth Hosp
city: Prahan
country: Australia
facility: Alfred Hosp
city: Wien
country: Austria
facility: Pulmologisches Zentrum Der Stadt Wien
city: Manguinhos RJ
country: Brazil
facility: Hosp Evandro Chagas Fioernz
city: Sao Paulo
country: Brazil
facility: Castelo
city: Sao Paulo
country: Brazil
facility: Fundacao Zerbini Casa Da Aids
city: Sao Paulo
country: Brazil
facility: Hosp Do Servidor Publico Estadual De Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hosp Heliopolis
city: Vancouver
country: Canada
facility: Saint Paul's Hosp
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Gen Hosp
state: Ontario
city: Montreal
country: Canada
facility: Clinique Medicale du Quartier Latin
state: Quebec
city: Montreal
country: Canada
facility: Clinique Medicale L'Actuele
state: Quebec
city: Montreal
country: Canada
facility: Montreal Chest Institute
state: Quebec
city: Copenhagen
country: Denmark
facility: Righospitalet
city: Hvidovre
country: Denmark
facility: Hvidovre Univ Hosp
city: Compiegne
country: France
facility: Centre Hospitalier De Compiegne
city: Paris Cedex 18
country: France
facility: Groupe Hospitalier Bichat-Claude Bernard
city: Paris
country: France
facility: CHU De Bicetre
city: Villejuif
country: France
facility: Hopital Paul Brousse
city: Berlin
country: Germany
facility: EPIMED
city: Dusseldorf
country: Germany
facility: Heinrich Heine Universitat
city: Frankfurt
country: Germany
facility: Klinikum Der Johann Wolfgang Goethe Universitat
city: Hamburg
country: Germany
facility: Allgemeines Krankenhaus St Georg
city: Koeln
country: Germany
facility: Univ Zu Koeln
city: Warszawa
country: Poland
facility: Ctr of AIDS Diagnosis and Treatment
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico Inc
city: Belford Gardens
country: South Africa
facility: Miller
city: Johannesburg
country: South Africa
facility: Cyrildene
city: Parktown
country: South Africa
facility: Wits Medical School
city: Barcelona
country: Spain
facility: Hosp Germans Trias I Pujol
city: Madrid
country: Spain
facility: Hosp Carlos III
city: Madrid
country: Spain
facility: Hosp De Mostoles
city: Madrid
country: Spain
facility: Hosp Doce De Octubre
city: Madrid
country: Spain
facility: Hosp La Paz
city: Sevilla
country: Spain
facility: Hosp Virgen Del Rocio
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
city: Brighton
country: United Kingdom
facility: Brighton Gen Hosp
city: London
country: United Kingdom
facility: Imperial College School of Medicine
city: London
country: United Kingdom
facility: Royal Free Hosp
Study officials:
References:
citation: Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9. doi: 10.1097/00002030-200101050-00002.