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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:
Information provided by:
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

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: Endpoint Classification: Safety Study
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated 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

Ages Eligible for Study:   6 Months to 13 Years
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

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
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
 Saquinavir
Nelfinavir
Anti-Retroviral Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013