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

Launched by ABBOTT · Aug 30, 2001

Keywords

ClinConnect Summary

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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.