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The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir

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ClinicalTrials.gov Identifier: NCT00000898
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : February 17, 2012
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The purpose of this study is to see if staggering doses of nelfinavir, ritonavir, and saquinavir has any effect on the interactions between these drugs.

Condition or disease Intervention/treatment
HIV Infections Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Saquinavir

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Primary Purpose: Treatment
Official Title: A Prototype Study to Test the Effect of Staggered Dosing on the Pharmacokinetic Interactions Between Paired Combinations of Nelfinavir (NFV), Ritonavir (RTV), and Soft Gelatin Capsule of Saquinavir (SQVsgc)
Study Completion Date : May 2000

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U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

Patients must have:

  • Absence of HIV-1 infection as documented by any licensed ELISA test kit within 14 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Any medical condition that, in the opinion of the investigator, would interfere with the patient's ability to participate in this protocol.

Patients with the following prior conditions and symptoms are excluded:

  • History of chronic illness such as hypertension, coronary artery disease, arthritis, diabetes, or any chronic gastrointestinal conditions that might interfere with drug absorption.

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 ClinicalTrials.gov identifier (NCT number): NCT00000898


Locations
United States, California
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Univ of California/ San Francisco / Dept of Medicine
San Francisco, California, United States, 94110
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Blaschke T
Study Chair: Flexner C
Study Chair: Sheiner L

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000898     History of Changes
Other Study ID Numbers: ACTG 378
11339 ( Registry Identifier: DAIDS ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Interactions
Drug Therapy, Combination
Saquinavir
HIV Protease Inhibitors
Ritonavir
Nelfinavir

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
Ritonavir
Nelfinavir
Saquinavir
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