The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir
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| ClinicalTrials.gov Identifier: NCT00000898 |
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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. | |||||||||
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* 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 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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