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
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Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
Tracking Information | ||||||||||
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First Submitted Date ICMJE | November 2, 1999 | |||||||||
First Posted Date ICMJE | August 31, 2001 | |||||||||
Last Update Posted Date | February 17, 2012 | |||||||||
Study Start Date ICMJE | Not Provided | |||||||||
Primary Completion Date | Not Provided | |||||||||
Current Primary Outcome Measures ICMJE | Not Provided | |||||||||
Original Primary Outcome Measures ICMJE | Not Provided | |||||||||
Change History | Complete list of historical versions of study NCT00000898 on ClinicalTrials.gov Archive Site | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | |||||||||
Current Other Outcome Measures ICMJE | Not Provided | |||||||||
Original Other Outcome Measures ICMJE | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir | |||||||||
Official Title ICMJE | 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) | |||||||||
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. | |||||||||
Detailed Description | Not Provided | |||||||||
Study Type ICMJE | Interventional | |||||||||
Study Phase | Not Applicable | |||||||||
Study Design ICMJE | Primary Purpose: Treatment | |||||||||
Condition ICMJE | HIV Infections | |||||||||
Intervention ICMJE |
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Study Arms | Not Provided | |||||||||
Publications * | 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. | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Enrollment ICMJE |
18 | |||||||||
Original Enrollment ICMJE | Same as current | |||||||||
Actual Study Completion Date | May 2000 | |||||||||
Primary Completion Date | Not Provided | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded:
Patients with the following prior conditions and symptoms are excluded:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||||||||
Accepts Healthy Volunteers | Yes | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT00000898 | |||||||||
Other Study ID Numbers ICMJE | ACTG 378 11339 ( Registry Identifier: DAIDS ES ) |
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Has Data Monitoring Committee | Not Provided | |||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||
IPD Sharing Statement | Not Provided | |||||||||
Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | |||||||||
Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
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PRS Account | National Institute of Allergy and Infectious Diseases (NIAID) | |||||||||
Verification Date | February 2012 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |