A Study of Ritonavir (ABT-538) When Used With Nelfinavir in HIV-Infected Patients

NCT ID: NCT00002201

Last Updated: 2009-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Ritonavir

Intervention Type: DRUG

Nelfinavir mesylate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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 of age.
• Access to a refrigerator for storing study drug.

Prior Medication:

Allowed:

Anti-HIV therapy other than protease inhibitor therapy.

Exclusion Criteria

Co-existing Condition:

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 treatment regimens.

Concurrent Medication:

Excluded:

• 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.

Prior Medication:

Excluded:

• 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Locations

Johns Hopkins Hosp

Baltimore, Maryland, United States

Countries

United States

References

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. doi: 10.1097/00042560-200012010-00005.

Reference Type: BACKGROUND

PMID: 11114832 (View on PubMed)

Other Identifiers

M96-581

Identifier Type: -

Identifier Source: secondary_id

245D

Identifier Type: -

Identifier Source: org_study_id