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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000898
First received: November 2, 1999
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
HIV Infections
 Drug: Ritonavir
Drug: Nelfinavir mesylate
Drug: Saquinavir

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 18
Study Completion Date: May 2000
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Click here for more information about Saquinavir  This link exits the ClinicalTrials.gov site
Click here for more information about Ritonavir  This link exits the ClinicalTrials.gov site
Click here for more information about Nelfinavir mesylate  This link exits the ClinicalTrials.gov site

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
Study First Received: November 2, 1999
Last Updated: February 16, 2012
Health Authority: United States: Federal Government

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
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
 Saquinavir
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 June 17, 2013