Clinical Trials

MainTitle

Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants

This study has been completed
Sponsor
Agouron Pharmaceuticals


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002164

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: May 1999
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Nelfinavir mesylate
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Enrollment: 24

Detailed Description:

This is a study of the safety, tolerability and pharmacokinetics of a Viracept pediatric powder formulation with milk or formula. First a single dose will be administered. After the patient population is divided into 4 groups by age, an optimal dose will be determined for each group. This optimal dose will be given 3 times a day for a 6 week primary observation period, plus an optional 6 month extension.
NOTE: During the single dose portion of this study, patients may be untreated or may continue treatment with their current nucleoside antiretroviral therapy. During multiple dose administration of Viracept, antiretroviral therapy will be intensified by either adding or modifying therapy. Antiretroviral therapies will be limited to those currently licensed including zidovudine, lamivudine, stavudine, didanosine or zalcitabine.

Eligibility

Eligibility

Ages Eligible for Study: up to 13 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria
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.

  • Exclusion Criteria
    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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002164

Locations

United States, California
UCLA School of Medicine / Dept of Pediatrics
Los Angeles, California, United States, 90024

Sponsors and Collaborators

Agouron Pharmaceuticals
More Information

More Information


Responsible Party: Agouron Pharmaceuticals  
ClinicalTrials.gov Identifier: NCT00002164   History of Changes  
Other Study ID Numbers: 259E  
  AG 1343-524  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Biological Availability
HIV Protease Inhibitors
Dosage Forms
Nelfinavir

Additional relevant MeSH terms:
HIV Infections
Nelfinavir

ClinicalTrials.gov processed this data on September 16, 2019
This information is provided by ClinicalTrials.gov.