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

NCT ID: NCT00000898

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2000-05-31

Brief Summary

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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

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Conditions

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HIV Infections

Keywords

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Drug Interactions Drug Therapy, Combination Saquinavir HIV Protease Inhibitors Ritonavir Nelfinavir

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Ritonavir

Intervention Type DRUG

Nelfinavir mesylate

Intervention Type DRUG

Saquinavir

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Blaschke T

Role: STUDY_CHAIR

Flexner C

Role: STUDY_CHAIR

Sheiner L

Role: STUDY_CHAIR

Locations

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San Francisco Gen Hosp

San Francisco, California, United States

Site Status

Univ of California/ San Francisco / Dept of Medicine

San Francisco, California, United States

Site Status

Stanford Univ Med Ctr

Stanford, California, United States

Site Status

Johns Hopkins Hosp

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12732841 (View on PubMed)

Other Identifiers

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11339

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 378

Identifier Type: -

Identifier Source: org_study_id