HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Adolescent Behavior, HIV Protease Inhibitors, Ritonavir, Indinavir
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.
Interventions
DRUGIndinavir sulfate
DRUGRitonavir
Sponsors
Abbott
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed