A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients
Information provided by (Responsible Party)
First received: November 2, 1999
Last updated: February 19, 2009
Last Verified: February 2009
History of Changes
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.
Drug : Indinavir sulfate
Drug : Ritonavir
Primary Purpose: Treatment
|Official Title:||Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID|
Further study details as provided by Abbott:
|Ages Eligible for Study:||12 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
- 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.
- Indinavir 800 mg three times a day plus unspecified nucleosides for at least 3 months.
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.
Patients with the following prior conditions are excluded:
Prior treatment with ritonavir.
History of active substance abuse (i.e., recreational drugs or alcohol).
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002223
Locations Show More
|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|
|Philadelphia, Pennsylvania, United States, 19107|
Sponsors and CollaboratorsAbbott
|ClinicalTrials.gov 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
HIV Protease Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.