Back to resultsThe Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ritonavir
Nelfinavir mesylate
Saquinavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Interactions, Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Ritonavir, Nelfinavir
Eligibility 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.
Sites / Locations
- San Francisco Gen Hosp
- Univ of California/ San Francisco / Dept of Medicine
- Stanford Univ Med Ctr
- Johns Hopkins Hosp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000898
First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00000898
Brief Title
The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir
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 Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2000 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Interactions, Drug Therapy, Combination, Saquinavir, HIV Protease Inhibitors, Ritonavir, Nelfinavir
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
18 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ritonavir
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Saquinavir
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blaschke T
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Flexner C
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sheiner L
Official's Role
Study Chair
Facility Information:
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Univ of California/ San Francisco / Dept of Medicine
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Stanford Univ Med Ctr
City
Stanford
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12732841
Citation
Washington CB, Flexner C, Sheiner LB, Rosenkranz SL, Segal Y, Aberg JA, Blaschke TF; AIDS Clinical Trials Group Protocol (ACTG 378) Study Team. Effect of simultaneous versus staggered dosing on pharmacokinetic interactions of protease inhibitors. Clin Pharmacol Ther. 2003 May;73(5):406-16. doi: 10.1016/s0009-9236(03)00006-7.
Results Reference
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The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir
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