The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: August 1997
History of Changes
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.
Drug : Nelfinavir mesylate
Drug : Saquinavir
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:
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
Contacts and LocationsChoosing 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 Show More
|United States, New Jersey|
|Hoffmann - La Roche Inc|
|Nutley, New Jersey, United States, 071101199|
Sponsors and CollaboratorsHoffmann-La Roche
|Responsible Party:||Hoffmann-La Roche|
|ClinicalTrials.gov Identifier:||NCT00002380 History of Changes|
|Other Study ID Numbers:||229K|
|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
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on October 15, 2019
This information is provided by ClinicalTrials.gov.