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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Two Forms of Saquinavir Combined with Other Anti-HIV Drugs in HIV-Infected Infants and Children  The Safety and Effectiveness of Two Forms of Saquinavir Combined with Other Anti-HIV Drugs in HIV-Infected Infants and Children
The Safety and Effectiveness of Two Forms of Saquinavir Combined with Other Anti-HIV Drugs in HIV-Infected Infants and Children
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Open Label, Safety Study
Minimum Age/Maximum Age: 6 Months/13 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 28
Location and Contact Information:
Hoffmann - La Roche Inc
Nutley, New Jersey, 071101199
United States
Additional Information:
Study ID Numbers: 229K; NV 15445
Study Start Date:
Record last reviewed: August 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002380
Other Hiv Infections Studies:
1. A Multi-Center, Open-Label, Ascending, Multiple Oral dose, Safety, Tolerance and Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Patients With Acquired Immune Deficiency Syndrome (AIDS) or AIDS-Related Complex (ARC)
2. Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
3. A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
4. A Study of Viracept in HIV-Positive Women
5. Immune and Viral Outcomes of HIV-1 Therapy Interruption
Related Studies:
Other HIV Infections Clinical Trials
Other New Jersey Clinical Trials
Other Nutley Clinical Trials
The Safety and Effectiveness of Two Forms of Saquinavir Combined with Other Anti-HIV Drugs in HIV-Infected Infants and Children
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