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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
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: Primary Purpose: Treatment
Official Title: Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID

Resource links provided by NLM:

Further study details as provided by Abbott:


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • 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:


Prior treatment with ritonavir.

Risk Behavior:


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


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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00002223

United States, California
AIDS Healthcare Foundation
Los Angeles, California, United States, 90027
Tower Infectious Diseases
Los Angeles, California, United States, 90048
United States, Florida
Urgent Care Ctr / North Broward Hosp District
Fort Lauderdale, Florida, United States, 33316
Goodgame Med Ctr / Central Florida Research Initiati
Maitland, Florida, United States, 32751
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
  More Information Identifier: NCT00002223     History of Changes
Other Study ID Numbers: 245E
Study First Received: November 2, 1999
Last Updated: February 19, 2009

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on April 24, 2017