NCT00002164

Brief Summary

To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard tablet formulation in older children (7 to 13 years of age) will also be conducted.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

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

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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

May 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Biological AvailabilityHIV Protease InhibitorsDosage FormsNelfinavir

Interventions

Nelfinavir mesylateDRUG

Eligibility Criteria

Age1 Day - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Administration of Pneumocystis carinii pneumonia prophylaxis according to CDC guidelines will be permitted.
  • Patients must have:
  • For children \>= 3 months to 13 years of age:
  • HIV infection. For children \<3 months of age:
  • HIV infection or exposure.
  • Newborns must have birth weight \>= 2500 gm.
  • Absence at screen of any serious or unstable medical conditions.
  • Parent or guardian able to give written informed consent and willing to comply with study requirements.

You may not qualify if:

  • Co-existing Condition:
  • Patients with any of the following symptoms or conditions are excluded:
  • Children with HIV associated malignancy requiring chemotherapy.
  • Children with clinical or laboratory assessments greater than Grade 1 in the Toxicity Table at the time of the screening.
  • Concurrent Medication:
  • Excluded:
  • Chemotherapy.
  • Prior Medication:
  • Excluded:
  • Protease inhibitors.
  • NOTE:
  • Patients who have taken investigational agents, immunomodulators, HIV-1 vaccines, glucocorticoids or unconventional therapies within one month prior to the day 0 of the study must be evaluated to determine the impact of these treatments on the study. Patients may be included or excluded on a case to case basis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA School of Medicine / Dept of Pediatrics

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Nelfinavir

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 Compounds

Study Design

Study Type
interventional
Phase
phase 1
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: 1999-05

Locations

US(1)