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| Sponsored by: |
Abbott |
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00004578 |
Purpose
To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Lopinavir/Ritonavir Drug: Lamivudine Drug: Stavudine |
Phase I Phase II |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Lamivudine Stavudine Ritonavir Lopinavir |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients |
| Enrollment: | 100 |
| Study Start Date: | November 1997 |
| Study Completion Date: | April 2005 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added.
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Drug: 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
Drug: Lamivudine
150 mg, every 12 hours
Drug: Stavudine
40 mg every 12 hours
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2: Active Comparator
Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.
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Drug: 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
Drug: Lamivudine
150 mg, every 12 hours
Drug: Stavudine
40 mg every 12 hours
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
History of:
Contacts and Locations| United States, California | |||||
| Pacific Oaks Research | |||||
| Beverly Hills, California, United States, 90211 | |||||
| United States, Colorado | |||||
| University of Colorado Health Sciences Center | |||||
| Denver, Colorado, United States, 80262 | |||||
| United States, Georgia | |||||
| AIDS Research Consortium of Atlanta | |||||
| Atlanta, Georgia, United States, 30308 | |||||
| United States, Illinois | |||||
| Northwestern University Medical School | |||||
| Chicago, Illinois, United States, 60611 | |||||
| Rush-Presbyterian-St. Luke's Medical Center | |||||
| Chicago, Illinois, United States, 60612 | |||||
| United States, Massachusetts | |||||
| Beth Israel Deaconess Medical Center | |||||
| Boston, Massachusetts, United States, 02215 | |||||
| United States, New York | |||||
| Cornell Clinical Trials Unit - Chelsea Center | |||||
| New York, New York, United States, 10011 | |||||
| United States, North Carolina | |||||
| Duke University Medical Center | |||||
| Durham, North Carolina, United States, 27710 | |||||
| University of North Carolina at Chapel Hill | |||||
| Chapel Hill, North Carolina, United States, 27516 | |||||
| United States, Texas | |||||
| Baylor College of Medicine | |||||
| Houston, Texas, United States, 77030 | |||||
| Abbott |
| Study Director: | George Hanna, MD | Abbott |
More Information
|
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)
  |
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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.
  |
| Responsible Party: | Abbott ( George Hanna, MD, Anti-viral Global Project Head ) |
| Study ID Numbers: | 285A, M97-720 |
| First Received: | November 2, 1999 |
| Last Updated: | April 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004578 |
| Health Authority: | United States: Food and Drug Administration |
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