ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects
NCT ID: NCT00004578
Last Updated: 2008-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
100 participants
INTERVENTIONAL
1997-11-30
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Group 1, n=32 initiated with ABT-378 \& ritonavir; after 3 wks stavudine and lamivudine was added.
Lopinavir/Ritonavir
Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
Lamivudine
150 mg, every 12 hours
Stavudine
40 mg every 12 hours
2
Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.
Lopinavir/Ritonavir
Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
Lamivudine
150 mg, every 12 hours
Stavudine
40 mg every 12 hours
Interventions
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Lopinavir/Ritonavir
Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs
Lamivudine
150 mg, every 12 hours
Stavudine
40 mg every 12 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* antiretroviral-adult males
* non-pregnant
* non-lactating females at least 18-years old with plasma HIV-1 RNA \> 5000 copies/mL, who were not acutely ill
Exclusion Criteria
* prior antiretroviral therapy
* significant drug hypersensitivity
* psychiatric illness that precludes compliance
* an active substance abuser
* positive test results for drug abuse
* abnormal lab test results (hemoglobin, absolute neutrophil count, platelet count, SGPT/AST or SGPT/ALT, creatinine, fasting triglycerides, significant abnormal ECG results
* pregnancy or lactating female
* received another investigational drug within 28 days of study initiation
* unlikely to comply or unsuitable candidate in the opinion of the investigator
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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George Hanna, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Pacific Oaks Research
Beverly Hills, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Northwestern University Medical School
Chicago, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cornell Clinical Trials Unit - Chelsea Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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References
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Murphy R, King M, Brun S, Orth K, Hicks C, Eron J, Thommes J, Gulick R, Thompson M, White C, Benson C, Hammer S, Kessler H, Bertz R, Hsu A, Kempf D, Sun E, Japour A. ABT-378/ritonavir therapy in antiretroviral-naive HIV-I infected patients for 24 weeks. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:69 (abstract no 15)
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.
Other Identifiers
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M97-720
Identifier Type: -
Identifier Source: secondary_id
285A
Identifier Type: -
Identifier Source: org_study_id