Back to resultsA Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lopinavir/Ritonavir
Nevirapine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Nevirapine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, ABT 378
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.
Sites / Locations
- Univ of Alabama at Birmingham
- Phoenix Body Positive
- Pacific Oaks Med Group
- Orange County Ctr for Special Immunology
- AIDS Healthcare Foundation
- Tower ID Med Associates
- UCLA CARE Ctr
- San Francisco Veterans Administration Med Ctr
- Harbor - UCLA Med Ctr
- Yale Univ / AIDS Clinical Trials Unit
- Univ of Miami School of Medicine
- Infectious Disease Research Institute
- AIDS Research Consortium of Atlanta
- Emory Univ
- Cook County Hosp
- AIDS Research Alliance - Chicago
- Division of Inf Diseases/ Indiana Univ Hosp
- Univ of Kansas School of Medicine
- Tulane Univ Med School
- Johns Hopkins Hosp
- Boston Med Ctr
- Community Research Initiative of New England
- Univ of Michigan Hospitals and Health Ctrs
- Abbott Northwestern Hosp
- Saint Michael's Med Ctr / Dept of Infectious Diseases
- St Michaels Med Ctr
- Beth Israel Med Ctr
- Cornell Clinical Trials Unit - Chelsea Clinic
- Howard Grossman
- SUNY / Health Sciences Ctr at Stony Brook
- SUNY at Stony Brook / Div of Infectious Disease
- Duke Univ Med Ctr / Infectious Disease Clinic
- Holmes Hosp / Univ of Cincinnati Med Ctr
- Associates in Med and Mental Health
- Oregon Health Sciences Univ
- Philadelphia FIGHT
- Stephen Hauptman
- The Miriam Hosp
- Oaklawn Physicians Group
- Univ of Texas Southwestern Med Ctr
- Univ of Texas / Med Branch at Galveston
- Joseph C Gathe
- Univ of Utah Med School / Clinical Trials Ctr
- Infectious Disease Physicians Inc
- Univ of Virginia Health Sciences Ctr
- Univ of Wisconsin
- Royal Brisbane Hosp
- Pulmologisches Zentrum Der Stadt Wien
- Hosp Evandro Chagas Fioernz
- Castelo
- Fundacao Zerbini Casa Da Aids
- Hosp Do Servidor Publico Estadual De Sao Paulo
- Hosp Heliopolis
- Saint Paul's Hosp
- Ottawa General Hospital
- Sunnybrook Health Science Ctr
- Toronto Gen Hosp
- Clinique Medicale du Quartier Latin
- Clinique Medicale L'Actuele
- Montreal Chest Institute
- Righospitalet
- Hvidovre Univ Hosp
- Odense Univ Hosp
- Groupe Hospitalier Bichat-Claude Bernard
- CHU De Bicetre
- Hopital Gustave Dron
- Hopital Paul Brousse
- EPIMED
- Heinrich Heine Universitat
- Klinikum Der Johann Wolfgang Goethe Universitat
- Allgemeines Krankenhaus St Georg
- Univ Zu Koeln
- Aids Study Group Mannheim
- Ctr of AIDS Diagnosis and Treatment
- Ponce Univ Hosp
- Miller
- Cyrildene
- Hosp Germans Trias I Pujol
- Hosp Carlos III
- Hosp De Mostoles
- Hosp Doce De Octubre
- Hosp La Paz
- Hosp Virgen Del Rocio
- Universitatsspital Zurich
- Brighton Gen Hosp
- Chelsea and Westminster Hosp
- Imperial College School of Medicine
- Royal Free Hosp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00004581
Brief Title
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
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
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:
ABT-378/RTV plus NVP plus 2 NRTIs; or
Investigator-selected PI(s) plus NVP plus 2 NRTIs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Nevirapine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, ABT 378
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir
Intervention Type
Drug
Intervention Name(s)
Nevirapine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Pacific Oaks Med Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Orange County Ctr for Special Immunology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
900276069
Country
United States
Facility Name
Tower ID Med Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
San Francisco Veterans Administration Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Yale Univ / AIDS Clinical Trials Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Infectious Disease Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory Univ
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
AIDS Research Alliance - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Division of Inf Diseases/ Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Boston Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Community Research Initiative of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
Univ of Michigan Hospitals and Health Ctrs
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
481090378
Country
United States
Facility Name
Abbott Northwestern Hosp
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Saint Michael's Med Ctr / Dept of Infectious Diseases
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
St Michaels Med Ctr
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Cornell Clinical Trials Unit - Chelsea Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Howard Grossman
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
SUNY at Stony Brook / Div of Infectious Disease
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Duke Univ Med Ctr / Infectious Disease Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Holmes Hosp / Univ of Cincinnati Med Ctr
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Associates in Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Oregon Health Sciences Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
972109951
Country
United States
Facility Name
Philadelphia FIGHT
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Stephen Hauptman
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The Miriam Hosp
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Oaklawn Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Univ of Texas / Med Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550835
Country
United States
Facility Name
Joseph C Gathe
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Univ of Utah Med School / Clinical Trials Ctr
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
Facility Name
Univ of Virginia Health Sciences Ctr
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Univ of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Royal Brisbane Hosp
City
Herston
Country
Australia
Facility Name
Pulmologisches Zentrum Der Stadt Wien
City
Wien
Country
Austria
Facility Name
Hosp Evandro Chagas Fioernz
City
Manguinhos RJ
Country
Brazil
Facility Name
Castelo
City
Sao Paulo
Country
Brazil
Facility Name
Fundacao Zerbini Casa Da Aids
City
Sao Paulo
Country
Brazil
Facility Name
Hosp Do Servidor Publico Estadual De Sao Paulo
City
Sao Paulo
Country
Brazil
Facility Name
Hosp Heliopolis
City
Sao Paulo
Country
Brazil
Facility Name
Saint Paul's Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Science Ctr
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Gen Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Clinique Medicale du Quartier Latin
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Clinique Medicale L'Actuele
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Montreal Chest Institute
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Righospitalet
City
Copenhagen
Country
Denmark
Facility Name
Hvidovre Univ Hosp
City
Hvidovre
Country
Denmark
Facility Name
Odense Univ Hosp
City
Odense C
Country
Denmark
Facility Name
Groupe Hospitalier Bichat-Claude Bernard
City
Paris Cedex 18
Country
France
Facility Name
CHU De Bicetre
City
Paris
Country
France
Facility Name
Hopital Gustave Dron
City
Tourcoing
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
Country
France
Facility Name
EPIMED
City
Berlin
Country
Germany
Facility Name
Heinrich Heine Universitat
City
Dusseldorf
Country
Germany
Facility Name
Klinikum Der Johann Wolfgang Goethe Universitat
City
Frankfurt
Country
Germany
Facility Name
Allgemeines Krankenhaus St Georg
City
Hamburg
Country
Germany
Facility Name
Univ Zu Koeln
City
Koeln
Country
Germany
Facility Name
Aids Study Group Mannheim
City
Mannheim
Country
Germany
Facility Name
Ctr of AIDS Diagnosis and Treatment
City
Warszawa
Country
Poland
Facility Name
Ponce Univ Hosp
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
Miller
City
Belford Gardens
Country
South Africa
Facility Name
Cyrildene
City
Johannesburg
Country
South Africa
Facility Name
Hosp Germans Trias I Pujol
City
Barcelona
Country
Spain
Facility Name
Hosp Carlos III
City
Madrid
Country
Spain
Facility Name
Hosp De Mostoles
City
Madrid
Country
Spain
Facility Name
Hosp Doce De Octubre
City
Madrid
Country
Spain
Facility Name
Hosp La Paz
City
Madrid
Country
Spain
Facility Name
Hosp Virgen Del Rocio
City
Sevilla
Country
Spain
Facility Name
Universitatsspital Zurich
City
Zurich
Country
Switzerland
Facility Name
Brighton Gen Hosp
City
Brighton
Country
United Kingdom
Facility Name
Chelsea and Westminster Hosp
City
London
Country
United Kingdom
Facility Name
Imperial College School of Medicine
City
London
Country
United Kingdom
Facility Name
Royal Free Hosp
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
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