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