Clinical trial NCT00004581: A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
Official title: A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Nevirapine
HIV Protease Inhibitors
Ritonavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
ABT 378
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 300
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 compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

Detailed description: Patients receive 1 of the following:

1. ABT-378/RTV plus NVP plus 2 NRTIs; or
2. Investigator-selected PI(s) plus NVP plus 2 NRTIs.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 12 years old.
* Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
* Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
* Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
* Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have an active illness.
* Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
* Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
* Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
* Have received treatment with a PI other than their current PI.
* Are receiving chemotherapy for cancer.
* Are pregnant or breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Body Positive
state: Arizona
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: 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: Cook County Hosp
state: Illinois
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: Newark
country: United States
facility: Saint Michael's Med Ctr / Dept of Infectious Diseases
state: New Jersey
city: Newark
country: United States
facility: St Michaels 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 / Health Sciences Ctr at Stony Brook
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: 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: Galveston
country: United States
facility: Univ of Texas / Med Branch at Galveston
state: Texas
city: Houston
country: United States
facility: Joseph C Gathe
state: Texas
city: Salt Lake City
country: United States
facility: Univ of Utah Med School / Clinical Trials Ctr
state: Utah
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: 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: Sunnybrook Health Science Ctr
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: Odense C
country: Denmark
facility: Odense Univ Hosp
city: Paris Cedex 18
country: France
facility: Groupe Hospitalier Bichat-Claude Bernard
city: Paris
country: France
facility: CHU De Bicetre
city: Tourcoing
country: France
facility: Hopital Gustave Dron
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: Mannheim
country: Germany
facility: Aids Study Group Mannheim
city: Warszawa
country: Poland
facility: Ctr of AIDS Diagnosis and Treatment
city: Ponce
country: Puerto Rico
facility: Ponce Univ Hosp
city: Belford Gardens
country: South Africa
facility: Miller
city: Johannesburg
country: South Africa
facility: Cyrildene
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: Chelsea and Westminster Hosp
city: London
country: United Kingdom
facility: Imperial College School of Medicine
city: London
country: United Kingdom
facility: Royal Free Hosp
Study officials:
References: