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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000898

Collaborator

(none)

Enrollment

Locations

4.5

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Saquinavir	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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)

Actual Study Completion Date :

May 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco Gen Hosp	San Francisco	California	United States	941102859
2	Univ of California/ San Francisco / Dept of Medicine	San Francisco	California	United States	94110
3	Stanford Univ Med Ctr	Stanford	California	United States	943055107
4	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287