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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002380

Run by

Hoffmann-La Roche

People needed

28

Last updated by the study team

2005-06-24

Who can join

Age: 1 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

Where it is running

• Hoffmann - La Roche Inc — Nutley, New Jersey, United States

Full record on ClinicalTrials.gov

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