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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00004578
First received: November 2, 1999
Last updated: April 2, 2008
Last verified: April 2008
  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 1
Phase 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
Northwestern University Medical School
Chicago, Illinois, United States, 60611
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)

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Lamivudine
Lopinavir
Reverse Transcriptase Inhibitors
Ritonavir
Stavudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014