A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004583
• Other study ID #: 285C
• Secondary ID: M98-863
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: February 19, 2009
• Start date: March 1999

Study information

• Verified date: February 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lopinavir/Ritonavir

• Nelfinavir mesylate

• Lamivudine

• Stavudine

Locations

Country	Name	City	State
Australia	Royal Brisbane Hosp	Herston
Australia	Royal Perth Hosp	Perth
Australia	Alfred Hosp	Prahan
Austria	Pulmologisches Zentrum Der Stadt Wien	Wien
Brazil	Hosp Evandro Chagas Fioernz	Manguinhos RJ
Brazil	Castelo	Sao Paulo
Brazil	Fundacao Zerbini Casa Da Aids	Sao Paulo
Brazil	Hosp Do Servidor Publico Estadual De Sao Paulo	Sao Paulo
Brazil	Hosp Heliopolis	Sao Paulo
Canada	Clinique Medicale du Quartier Latin	Montreal	Quebec
Canada	Clinique Medicale L'Actuele	Montreal	Quebec
Canada	Montreal Chest Institute	Montreal	Quebec
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Toronto Gen Hosp	Toronto	Ontario
Canada	Saint Paul's Hosp	Vancouver	British Columbia
Denmark	Righospitalet	Copenhagen
Denmark	Hvidovre Univ Hosp	Hvidovre
France	Centre Hospitalier De Compiegne	Compiegne
France	CHU De Bicetre	Paris
France	Groupe Hospitalier Bichat-Claude Bernard	Paris Cedex 18
France	Hopital Paul Brousse	Villejuif
Germany	EPIMED	Berlin
Germany	Heinrich Heine Universitat	Dusseldorf
Germany	Klinikum Der Johann Wolfgang Goethe Universitat	Frankfurt
Germany	Allgemeines Krankenhaus St Georg	Hamburg
Germany	Univ Zu Koeln	Koeln
Poland	Ctr of AIDS Diagnosis and Treatment	Warszawa
Puerto Rico	Clinical Research Puerto Rico Inc	San Juan
South Africa	Miller	Belford Gardens
South Africa	Cyrildene	Johannesburg
South Africa	Wits Medical School	Parktown
Spain	Hosp Germans Trias I Pujol	Barcelona
Spain	Hosp Carlos III	Madrid
Spain	Hosp De Mostoles	Madrid
Spain	Hosp Doce De Octubre	Madrid
Spain	Hosp La Paz	Madrid
Spain	Hosp Virgen Del Rocio	Sevilla
Switzerland	Universitatsspital Zurich	Zurich
United Kingdom	Brighton Gen Hosp	Brighton
United Kingdom	Imperial College School of Medicine	London
United Kingdom	Royal Free Hosp	London
United States	Univ of Michigan Hospitals and Health Ctrs	Ann Arbor	Michigan
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Emory Univ	Atlanta	Georgia
United States	Central Texas Med Foundation	Austin	Texas
United States	Johns Hopkins Hosp	Baltimore	Maryland
United States	Pacific Oaks Med Group	Beverly Hills	California
United States	Boston Med Ctr	Boston	Massachusetts
United States	Community Research Initiative of New England	Brookline	Massachusetts
United States	Univ of Virginia Health Sciences Ctr	Charlottesville	Virginia
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	Holmes Hosp / Univ of Cincinnati Med Ctr	Cincinnati	Ohio
United States	Oaklawn Physicians Group	Dallas	Texas
United States	Univ of Texas Southwestern Med Ctr	Dallas	Texas
United States	Duke Univ Med Ctr / Infectious Disease Clinic	Durham	North Carolina
United States	East Orange Veterans Administration Med Ctr	East Orange	New Jersey
United States	Orange County Ctr for Special Immunology	Fountain Valley	California
United States	Joseph C Gathe	Houston	Texas
United States	Division of Inf Diseases/ Indiana Univ Hosp	Indianapolis	Indiana
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	Tower ID Med Associates	Los Angeles	California
United States	UCLA CARE Ctr	Los Angeles	California
United States	Univ of Wisconsin	Madison	Wisconsin
United States	Steinhart Medical Associates	Miami	Florida
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Abbott Northwestern Hosp	Minneapolis	Minnesota
United States	Vanderbilt Univ Med Ctr	Nashville	Tennessee
United States	Yale Univ / AIDS Clinical Trials Unit	New Haven	Connecticut
United States	Tulane Univ Med School	New Orleans	Louisiana
United States	Beth Israel Med Ctr	New York	New York
United States	Cornell Clinical Trials Unit - Chelsea Clinic	New York	New York
United States	Howard Grossman	New York	New York
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	Stephen Hauptman	Philadelphia	Pennsylvania
United States	Oregon Health Sciences Univ	Portland	Oregon
United States	The Miriam Hosp	Providence	Rhode Island
United States	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	SUNY at Stony Brook / Div of Infectious Disease	Stony Brook	New York
United States	Infectious Disease Research Institute	Tampa	Florida
United States	Harbor - UCLA Med Ctr	Torrance	California
United States	Associates in Med and Mental Health	Tulsa	Oklahoma
United States	Univ of Kansas School of Medicine	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Brazil,  Canada,  Denmark,  France,  Germany,  Poland,  Puerto Rico,  South Africa,  Spain,  Switzerland,  United Kingdom, 

References & Publications (1)

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. — View Citation