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A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors

This study has been completed.

Sponsored by: Abbott
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00004580
  Purpose

The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected patients who previously have taken protease inhibitors. This study also examines how the body handles this combination of anti-HIV drugs.


Condition Intervention Phase
HIV Infections
Drug: Lopinavir/Ritonavir
Drug: Nevirapine
Phase I

MedlinePlus related topics:   AIDS   

Drug Information available for:   Ritonavir    Nevirapine    Lopinavir   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

- Antiretroviral regimen containing a protease inhibitor and one or two nucleoside reverse transcriptase inhibitors that has not changed in the last 12 weeks.

Patients must have:

- HIV infection with plasma HIV RNA of at least 1,000 copies/ml and less than or equal to 100,000 copies/ml at screening.

Prior Medication:

Allowed:

Naive to or has had less than 8 weeks of at least one nucleoside reverse transcriptase inhibitor and an acceptable regimen of two nucleoside reverse transcriptase inhibitors.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Medications that are contraindicated with ABT-378/ritonavir for the duration of the study, such as midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine and dihydroergotamine.
  • Over-the-counter medicine or alcohol, without knowledge or permission of the investigator.

Patients with the following prior conditions are excluded:

  • Evidence of acute illness determined by vital signs, physical examination, or laboratory results.
  • Clinically significant abnormal ECG results.
  • Positive test result for drug abuse with the exception of cannabis, unless the investigator anticipates cannabis use will interfere with compliance with the study.

Prior Medication:

Excluded:

  • Investigational drugs with the exception of Amprenavir within 28 days prior to the initiation of study dosing.
  • Treatment with a non-nucleoside reverse transcriptase inhibitor.
  • Treatment with a protease inhibitor different from the current protease inhibitor for more than 6 weeks prior to current regimen.
  • Treatment with more than one protease inhibitor concurrently.

Risk Behavior:

Excluded:

  • Active substance abuse, alcohol abuse, psychiatric illness.
  • Presumption, by investigator, of poor compliance to regimen.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004580

Locations
United States, California
San Francisco Gen Hosp / UCSF AIDS Program    
      San Francisco, California, United States, 94110
Pacific Oaks Research    
      Beverly Hills, California, United States, 90211
United States, Colorado
Univ of Colorado Health Sciences Ctr    
      Denver, Colorado, United States, 80262
United States, Georgia
AIDS Research Consortium of Atlanta    
      Atlanta, Georgia, United States, 30308
United States, Illinois
Rush Presbyterian St Lukes Med Ctr / Sect Infect Dise    
      Chicago, Illinois, United States, 60612
United States, North Carolina
Univ North Carolina at Chapel Hill / Dept of Medicine    
      Chapel Hill, North Carolina, United States, 27599
Duke Univ Med Ctr / Infectious Disease Clinic    
      Durham, North Carolina, United States, 27710
United States, Ohio
Univ of Cincinnati Med Ctr / Holmes Div Mail Loc 0405    
      Cincinnati, Ohio, United States, 452670405
United States, Pennsylvania
Univ of Pittsburgh    
      Pittsburgh, Pennsylvania, United States, 152132582
United States, Virginia
Infectious Disease Physicians Inc    
      Annandale, Virginia, United States, 22203

Sponsors and Collaborators
Abbott
  More Information


Study ID Numbers:   285B, M97-765
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004580
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination  
Nevirapine  
HIV Protease Inhibitors  
Ritonavir  
Reverse Transcriptase Inhibitors  

Study placed in the following topic categories:
Virus Diseases
Nevirapine
Sexually Transmitted Diseases, Viral
Lopinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 30, 2008




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