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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00002201
First received: November 2, 1999
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Ritonavir
Drug: Nelfinavir mesylate

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Ritonavir (ABT-538) in Combination With Nelfinavir in HIV-Infected Subjects.

Resource links provided by NLM:


Further study details as provided by Abbott:

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing 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
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Abbott
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002201     History of Changes
Other Study ID Numbers: 245D, M96-581
Study First Received: November 2, 1999
Last Updated: February 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
Nelfinavir
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Ritonavir
Nelfinavir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014