Search / Trial NCT00002223

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

Launched by ABBOTT · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Drug Therapy, Combination Adolescent Behavior Hiv Protease Inhibitors Ritonavir Indinavir

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.

About Abbott

Abbott is a global healthcare company dedicated to improving lives through innovative medical technologies, diagnostics, nutrition, and branded generic pharmaceuticals. With a commitment to advancing health and wellness, Abbott conducts clinical trials to evaluate the safety and efficacy of its diverse portfolio of products, which span multiple therapeutic areas, including cardiovascular, diabetes care, and neurology. The company employs rigorous research methodologies and collaborates with healthcare professionals and institutions worldwide to ensure the highest standards of clinical integrity and patient safety. Abbott's mission is to deliver impactful solutions that enhance patient outcomes and contribute to the advancement of global healthcare.

Locations

New York, New York, United States

Los Angeles, California, United States

Los Angeles, California, United States

Fort Lauderdale, Florida, United States

Maitland, Florida, United States

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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