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

HIV Infections Clinical Trial

Official title:

Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002223
• Other study ID #: 245E
• Secondary ID: M98-823
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: February 19, 2009

Study information

• Verified date: February 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Ritonavir

Locations

Country	Name	City	State
United States	Urgent Care Ctr / North Broward Hosp District	Fort Lauderdale	Florida
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	Tower Infectious Diseases	Los Angeles	California
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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States,