ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine Ritonavir Lopinavir Stavudine

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Proportion of subjects with viral load below the limit of quantitation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Time to loss of virologic response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with viral load below the limit of quantitation at each visit [ Time Frame: At each visit ] [ Designated as safety issue: No ]

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
Active Comparator: 1 Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added.	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 Other Names: ABT-387 Kaletra Lopinavir/Ritonavir Drug: Lamivudine 150 mg, every 12 hours Other Name: Lamivudine Drug: Stavudine 40 mg every 12 hours Other Name: Stavudine
Active Comparator: 2 Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.	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 Other Names: ABT-387 Kaletra Lopinavir/Ritonavir Drug: Lamivudine 150 mg, every 12 hours Other Name: Lamivudine Drug: Stavudine 40 mg every 12 hours Other Name: Stavudine

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

HIV-1 positive
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

History of:
- 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004578

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
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27516
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030

Sponsors and Collaborators

Abbott

Investigators

Study Director:

George Hanna, MD

Abbott

More Information

Publications:

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.

Responsible Party:	George Hanna, MD, Anti-viral Global Project Head, Abbott
ClinicalTrials.gov Identifier:	NCT00004578 History of Changes
Other Study ID Numbers:	285A, M97-720
Study First Received:	November 2, 1999
Last Updated:	April 2, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Stavudine
HIV Protease Inhibitors
Ritonavir
Lamivudine
Reverse Transcriptase Inhibitors

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Ritonavir
Lopinavir

Stavudine
Lamivudine
Reverse Transcriptase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012