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A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients
This study has been completed.
First Received: November 2, 1999   Last Updated: February 19, 2009   History of Changes
Sponsored by: Abbott
Information provided by: Abbott
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

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

Resource links provided by NLM:

  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

No publications provided

Study ID Numbers: 245E, M98-823
Study First Received: November 2, 1999
Last Updated: February 19, 2009
ClinicalTrials.gov Identifier: NCT00002223     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Drug Therapy, Combination
Adolescent Behavior
HIV Protease Inhibitors
Ritonavir
Indinavir

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Indinavir
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Indinavir
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Ritonavir
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on July 02, 2009