A Study of Ritonavir (ABT-538) When Used With Nelfinavir in HIV-Infected Patients
Safety and Efficacy of Ritonavir (ABT-538) in Combination With Nelfinavir in HIV-Infected Subjects.
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedFebruary 20, 2009
February 1, 2009
November 2, 1999
February 19, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (1)
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Related 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. doi: 10.1097/00042560-200012010-00005.
PMID: 11114832BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
February 20, 2009
Record last verified: 2009-02