NCT00000898

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable hiv-infections

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2000

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

Drug InteractionsDrug Therapy, CombinationSaquinavirHIV Protease InhibitorsRitonavirNelfinavir

Interventions

RitonavirDRUG
Nelfinavir mesylateDRUG
SaquinavirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • Absence of HIV-1 infection as documented by any licensed ELISA test kit within 14 days prior to study entry.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Univ of California/ San Francisco / Dept of Medicine

San Francisco, California, 94110, United States

Location

Stanford Univ Med Ctr

Stanford, California, 943055107, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Related 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. doi: 10.1016/s0009-9236(03)00006-7.

    PMID: 12732841BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

RitonavirNelfinavirSaquinavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingQuinolines

Study Officials

  • Blaschke T

    STUDY CHAIR

  • Flexner C

    STUDY CHAIR

  • Sheiner L

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

May 1, 2000

Last Updated

October 29, 2021

Record last verified: 2021-10

Locations

US(4)