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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002201
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : February 20, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Ritonavir Drug: Nelfinavir mesylate Not Applicable

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Ritonavir (ABT-538) in Combination With Nelfinavir in HIV-Infected Subjects.

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MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


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:


  • 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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002201

United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators

Publications: Identifier: NCT00002201     History of Changes
Other Study ID Numbers: 245D
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors