Clinical Trials

MainTitle

The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children

This study has been completed
Sponsor
Hoffmann-La Roche


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002380

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: August 1997
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Drug : Nelfinavir mesylate
Drug : Saquinavir
Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Pharmacokinetic and Safety Study of Saquinavir Soft Gelatin Capsules and Pediatric Pellet Formulations in Combination With Nucleoside Antiretroviral Agents With or Without Nelfinavir, in HIV-Infected Infants and Children

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

Enrollment: 28

Detailed Description:

This Phase I/II study will be conducted in 2 parts each lasting at least 24 weeks. Pharmacokinetics and safety data for part 1, a treatment regimen containing saquinavir and nucleoside antiretrovirals, will be collected for 8 weeks before proceeding to part 2. During the first 8 weeks, pharmacokinetic data will be analyzed to allow dose adjustments for individual patients and to confirm the starting dose estimates for part 2. In addition, safety data will be reviewed to ensure that saquinavir is well tolerated with nucleoside antiretrovirals before it is combined with a second protease inhibitor. In part 2, saquinavir will be combined with nelfinavir, a protease inhibitor recently approved for use in children. The pharmacokinetics and safety profile of these drugs in combination will be determined.

Eligibility

Eligibility

Ages Eligible for Study: 6 Months to 13 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria
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:
  • 6 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.
    1. 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.

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: NCT00002380

Locations

United States, New Jersey
Hoffmann - La Roche Inc
Nutley, New Jersey, United States, 071101199

Sponsors and Collaborators

Hoffmann-La Roche
More Information

More Information


Responsible Party: Hoffmann-La Roche  
ClinicalTrials.gov Identifier: NCT00002380   History of Changes  
Other Study ID Numbers: 229K  
  NV 15445  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination
HIV Protease Inhibitors
Dosage Forms
Saquinavir
Nelfinavir
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Nelfinavir
Saquinavir
Anti-Retroviral Agents

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.