NCT00002380

Brief Summary

To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside antiretroviral drugs (part 2), in HIV-infected infants and children.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

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
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

August 1, 1997

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationHIV Protease InhibitorsDosage FormsSaquinavirNelfinavirAnti-HIV Agents

Interventions

Nelfinavir mesylateDRUG
SaquinavirDRUG

Eligibility Criteria

Age6 Months - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients must have:
  • HIV infection according to standard definitions employed by the Pediatric AIDS Clinical Trials Group.
  • Laboratory evidence of immunosuppression (Centers for Disease Control and Prevention \[CDC\] categories 2 and 3), or symptomatic HIV disease (CDC categories A, B, and C).
  • At least 4 patients (2 in each parts 1 and 2) will be enrolled in each of three age strata:
  • months to 2 years; greater than 2 years to 6 years; and greater than 6 years to 13 years. NOTE:
  • For the purposes of analysis only, patients will be stratified by age.
  • \. Patients must be protease inhibitor therapy naive.
  • Antiretroviral agents other than those prescribed by the investigator.
  • Biologic response modifiers (other than erythropoietin, G-CSF, short course \[\<14 days\] corticosteroids, or intravenous immune globulin).
  • Other investigational drugs.
  • Drugs known to significantly interact with saquinavir and/or nelfinavir. Patients must be protease inhibitor therapy naive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoffmann - La Roche Inc

Nutley, New Jersey, 071101199, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

NelfinavirSaquinavir

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)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinolines

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1997-08

Locations

US(1)