A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients
Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID
2 other identifiers
interventional
N/A
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
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6 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedFebruary 20, 2009
February 1, 2009
November 2, 1999
February 19, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (6)
AIDS Healthcare Foundation
Los Angeles, California, 90027, United States
Tower Infectious Diseases
Los Angeles, California, 90048, United States
Urgent Care Ctr / North Broward Hosp District
Fort Lauderdale, Florida, 33316, United States
Goodgame Med Ctr / Central Florida Research Initiati
Maitland, Florida, 32751, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Stephen Hauptman
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
February 20, 2009
Record last verified: 2009-02