The purpose of this study is to see if it is safe and effective to give ritonavir plus
nelfinavir to HIV-infected patients. This study will also see how ritonavir and nelfinavir
are absorbed by the body and how they affect the level of HIV in the blood.
Minimum age: 12 Years.
Maximum age: N/A.
Patients must have:
- Documentation of a positive ELISA test for HIV confirmed by immunoblot, or a positive
HIV RNA test using the Roche PCR assay, or the Chiron bDNA assay.
- HIV RNA measurement of > 5,000 copies/ml within 3 weeks of baseline visit.
- Signed, informed consent from parent or legal guardian for patients less than 18 years
- Access to a refrigerator for storing study drug.
Anti-HIV therapy other than protease inhibitor therapy.
Patients with the following conditions or symptoms are excluded:
- Evidence of acute infection, as measured by vital signs, physical examination, 12-lead
electrocardiogram and laboratory assessments.
- Condition that may obscure the proper observation of the safety or activity of the
- Midazolam, alprazolam, clorazepate, diazepam, estazolam, flurazepam, triazolam,
zolpidem, quinidine, amiodarone, encainide, flecainide, propafenone, bepridil,
terfenadine, astemizole, cisapride, bupropion, clozapine, rifabutin, meperidine,
propoxyphene, piroxicam, pimozide, ergotamine, dihydroergotamine, and rifampin.
- Anti-retroviral therapy initiated prior to study entry.
- Any other medication, including over-the-counter medicine and alcohol, taken without
the permission of the primary investigator.
Patients with the following prior conditions are excluded:
- History of significant drug hypersensitivity.
- History of psychiatric illness that would preclude compliance with the protocol.
- Prior enrollment in this study.
- Investigational drugs within 30 days prior to drug administration.
- Prior treatment with licensed or investigational HIV protease inhibitor.
1. Active substance abuse.
- Positive urine screen for recreational drugs. NOTE:
- The presence of cannabis is not exclusionary unless the investigator believes its use
will interfere with patient compliance.
Raines CP, Flexner C, Sun E, Heath-Chiozzi M, Lewis RH, Fields C, Deetz C, Apuzzo L, Eshleman SH, Jackson JB, Gallant JE. Safety, tolerability, and antiretroviral effects of ritonavir-nelfinavir combination therapy administered for 48 weeks. J Acquir Immune Defic Syndr. 2000 Dec 1;25(4):322-8.