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NCT00000898 Clinical Trial

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

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000898
Other study ID # ACTG 378
Secondary ID 11339
Status Completed
Phase N/A
First received
Last updated
Est. completion date May 2000

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date May 2000
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ritonavir

• Nelfinavir mesylate

• Saquinavir

Locations
Country Name City State
United States Johns Hopkins Hosp Baltimore Maryland
United States San Francisco Gen Hosp San Francisco California
United States Univ of California/ San Francisco / Dept of Medicine San Francisco California
United States Stanford Univ Med Ctr Stanford California

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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