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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002223

Run by

Abbott

Last updated by the study team

2009-02-20

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.