- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002201
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Nelfinavir
Other Study ID Numbers
- 245D
- M96-581
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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