A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients
This study has been completed.
Information provided by:
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
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
||Endpoint Classification: Safety Study
Primary Purpose: Treatment
||Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID
|Ages Eligible for Study:
||12 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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 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 treatment with ritonavir.
History of active substance abuse (i.e., recreational drugs or alcohol).
- Indinavir 800 mg three times a day plus unspecified nucleosides for at least 3 months.
Choosing 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
|AIDS Healthcare Foundation
|Los Angeles, California, United States, 90027 |
|Tower Infectious Diseases
|Los Angeles, California, United States, 90048 |
|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 |
|Mount Sinai Med Ctr
|New York, New York, United States, 10029 |
|Philadelphia, Pennsylvania, United States, 19107 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||February 19, 2009
||United States: Food and Drug Administration
Keywords provided by Abbott:
Drug Therapy, Combination
HIV Protease Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on February 25, 2015
Acquired Immunodeficiency Syndrome
Immune System Diseases
Immunologic Deficiency Syndromes
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action