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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002223
• Date of registration: 02/11/1999
• Primary sponsor: Abbott
• Public title: A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients
• Scientific title: Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID
• Date of first enrolment: February 2004
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002223
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Indinavir sulfate

Drug: Ritonavir

Secondary ID(s)

245E

M98-823

Source(s) of Monetary Support

Please refer to primary and secondary sponsors