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A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients

This study has been completed.

Sponsored by: Abbott
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002223
  Purpose

The purpose of this study is to determine how many HIV-infected patients continue taking ritonavir/indinavir combination after having taken indinavir three times a day as part of their anti-HIV drug therapy. This study also examines the safety and effectiveness of the ritonavir/indinavir combination.


Condition Intervention
HIV Infections
Drug: Indinavir sulfate
Drug: Ritonavir

MedlinePlus related topics:   AIDS   

ChemIDplus related topics:   Indinavir    Indinavir Sulfate    Ritonavir   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Safety Study
Official Title:   Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 Mg TID
  Eligibility
Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria

Patients must have:

  • HIV infection.
  • CD4 cell count greater than 100 cells/microliter.
  • HIV RNA levels greater than 400 copies/microliter using the Roche Ultrasensitive assay.
  • No acute illness.
  • Consent of parent or guardian if less than legal age.
  • No prior enrollment in this study.
  • All entry criteria for this study met within 15 days prior to enrollment.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

Any condition that in the opinion of the investigator may obscure proper observation of the safety or activity of the treatment regimens used in this study.

Concurrent Medication:

Excluded:

  • Concurrent non-nucleoside reverse transcriptase inhibitors as part of the antiretroviral regimen.
  • Any of the following medications with ritonavir:
  • midazolam, clorazepate, diazepam, estazolam, flurazepam, triazolam, zolpidem, quinidine, amiodarone, encainide, flecainide, propafenone, bepridil, terfenadine, astemizole, cisapride, bupropion, clozapine, rifabutin, meperidine, propoxyphene, piroxicam, pimozide, dihydroergotamine, and ergotamine.
  • Any of the following medications with indinavir:
  • terfenadine, astemizole, cisapride, triazolam, midazolam. No requirement for rifampin or ketoconazole.
  • Any concurrent treatment with other protease inhibitors.
  • Other concurrent medication (including over-the-counter medicine or alcohol) without the knowledge and permission of the primary investigator.

Patients with the following prior conditions are excluded:

  • History of significant drug hypersensitivity.
  • Psychiatric illness that precludes compliance with the protocol.
  • Receipt of investigational drug within 30 days prior to administration of study drug.
  • History of acute or chronic pancreatitis.
  • Anticipation of poor patient compliance with protocol.

Prior Medication:

Excluded:

Prior treatment with ritonavir.

Risk Behavior:

Excluded:

History of active substance abuse (i.e., recreational drugs or alcohol).

Included:

- Indinavir 800 mg three times a day plus unspecified nucleosides for at least 3 months.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002223

Locations
United States, California
AIDS Healthcare Foundation    
      Los Angeles, California, United States, 90027
Tower Infectious Diseases    
      Los Angeles, California, United States, 90048
United States, Florida
Goodgame Med Ctr / Central Florida Research Initiati    
      Maitland, Florida, United States, 32751
Urgent Care Ctr / North Broward Hosp District    
      Fort Lauderdale, Florida, United States, 33316
United States, New York
Mount Sinai Med Ctr    
      New York, New York, United States, 10029
United States, Pennsylvania
Stephen Hauptman    
      Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators
Abbott
  More Information


Study ID Numbers:   245E, M98-823
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002223
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination  
Adolescent Behavior  
HIV Protease Inhibitors  
Ritonavir  
Indinavir  

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

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

ClinicalTrials.gov processed this record on September 16, 2008




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