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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.
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997
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: 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:

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.

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

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.
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Please refer to this study by its identifier: NCT00002380

United States, New Jersey
Hoffmann - La Roche Inc
Nutley, New Jersey, United States, 071101199
Sponsors and Collaborators
Hoffmann-La Roche
  More Information 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
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Retroviral Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on April 28, 2017