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A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients Clinical research trials and A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients. A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients clinical trial. Subjects typically recieve the finest healthcare available for their A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients  A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients
A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Abbott Laboratories ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacodynamics Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: 245D; M96-581
Study Start Date:
Record last reviewed: June 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002201
Other Hiv Infections Studies:
1. A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks
2. A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
3. A Trial of Two Doses of 2',3'-Dideoxycytidine (ddC) in the Treatment of Children With Symptomatic HIV Infection Who Are Intolerant of AZT and/or Who Show Progressive Disease While on AZT
4. Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients with HIV-Related Tuberculosis Treated with a Rifabutin-Based Regimen
5. A Pilot, Open-Label, Phase II, Randomized Study to Determine the Effects of Viracept on the Outcome of Cutaneous and Mucosal KS in AIDS Patients with CD4 <= 500 cells/mm3
Related Studies:
Other HIV Infections Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
A Study of Ritonavir (ABT-538) When Used with Nelfinavir in HIV-Infected Patients
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