A Study of Ritonavir (ABT-538) When Used With Nelfinavir in HIV-Infected Patients
Information provided by (Responsible Party)
First received: November 2, 1999
Last updated: February 19, 2009
Last Verified: February 2009
History of Changes
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.
Drug : Ritonavir
Drug : Nelfinavir mesylate
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Ritonavir (ABT-538) in Combination With Nelfinavir in HIV-Infected Subjects.|
Further study details as provided by Abbott:
|Ages Eligible for Study:||12 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
- 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.
- History of significant drug hypersensitivity.
- History of psychiatric illness that would preclude compliance with the protocol.
- Prior enrollment in this study.
- Investigational drugs within 30 days prior to drug administration.
- Prior treatment with licensed or investigational HIV protease inhibitor.
- Active substance abuse.
- Positive urine screen for recreational drugs. NOTE:
- The presence of cannabis is not exclusionary unless the investigator believes its use
Anti-HIV therapy other than protease inhibitor therapy.
Patients with the following conditions or symptoms are excluded:
Patients with the following prior conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002201
Locations Show More
|United States, Maryland|
|Johns Hopkins Hosp|
|Baltimore, Maryland, United States, 21287|
Sponsors and CollaboratorsAbbott
|ClinicalTrials.gov Identifier:||NCT00002201 History of Changes|
|Other Study ID Numbers:||245D|
|Study First Received:||November 2, 1999|
|Last Updated:||February 19, 2009|
Keywords provided by Abbott:Drug Therapy, Combination
HIV Protease Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on January 28, 2020
This information is provided by ClinicalTrials.gov.