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

HIV Infections Clinical Trial

Official title:

Safety and Efficacy of Ritonavir (ABT-538) in Combination With Nelfinavir in HIV-Infected Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002201
• Other study ID #: 245D
• Secondary ID: M96-581
• 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 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.

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:

• 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.

Study Design

Endpoint Classification: Pharmacodynamics Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Ritonavir

• Nelfinavir mesylate

Locations

Country	Name	City	State
United States	Johns Hopkins Hosp	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation