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

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 941102859
        • San Francisco Gen Hosp
      • San Francisco, California, United States, 94110
        • Univ of California/ San Francisco / Dept of Medicine
      • Stanford, California, United States, 943055107
        • Stanford Univ Med Ctr
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Flexner C
  • Study Chair: Sheiner L

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

May 1, 2000

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 378
  • 11339 (Registry Identifier: DAIDS ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Ritonavir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe