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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ritonavir
Nelfinavir mesylate
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Nelfinavir, Anti-HIV Agents

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
February 19, 2009
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00002201
Brief Title
A Study of Ritonavir (ABT-538) When Used With Nelfinavir in HIV-Infected Patients
Official Title
Safety and Efficacy of Ritonavir (ABT-538) in Combination With Nelfinavir in HIV-Infected Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Nelfinavir, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11114832
Citation
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.
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A Study of Ritonavir (ABT-538) When Used With Nelfinavir in HIV-Infected Patients

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