Clinical trial NCT00002223: A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients
Official title: Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Adolescent Behavior
HIV Protease Inhibitors
Ritonavir
Indinavir
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Los Angeles
country: United States
facility: Tower Infectious Diseases
state: California
city: Fort Lauderdale
country: United States
facility: Urgent Care Ctr / North Broward Hosp District
state: Florida
city: Maitland
country: United States
facility: Goodgame Med Ctr / Central Florida Research Initiati
state: Florida
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: Philadelphia
country: United States
facility: Stephen Hauptman
state: Pennsylvania
Study officials:
References: