Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: May 1999
History of Changes
To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age). An evaluation of the relative bioavailability of the pediatric powder formulation vs. a standard tablet formulation in older children (7 to 13 years of age) will also be conducted.
Drug : Nelfinavir mesylate
Primary Purpose: Treatment
|Official Title:||Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
This is a study of the safety, tolerability and pharmacokinetics of a Viracept pediatric
powder formulation with milk or formula. First a single dose will be administered. After the
patient population is divided into 4 groups by age, an optimal dose will be determined for
each group. This optimal dose will be given 3 times a day for a 6 week primary observation
period, plus an optional 6 month extension.
NOTE: During the single dose portion of this study, patients may be untreated or may continue treatment with their current nucleoside antiretroviral therapy. During multiple dose administration of Viracept, antiretroviral therapy will be intensified by either adding or modifying therapy. Antiretroviral therapies will be limited to those currently licensed including zidovudine, lamivudine, stavudine, didanosine or zalcitabine.
|Ages Eligible for Study:||up to 13 Years|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Administration of Pneumocystis carinii pneumonia prophylaxis according to CDC guidelines will be permitted.
Patients must have:
- For children >= 3 months to 13 years of age:
- HIV infection. For children <3 months of age:
- HIV infection or exposure.
- Newborns must have birth weight >= 2500 gm.
- Absence at screen of any serious or unstable medical conditions.
- Parent or guardian able to give written informed consent and willing to comply with study requirements.
- Children with HIV associated malignancy requiring chemotherapy.
- Children with clinical or laboratory assessments greater than Grade 1 in the Toxicity Table at the time of the screening.
- Protease inhibitors.
- Patients who have taken investigational agents, immunomodulators, HIV-1 vaccines,
Patients with any of the following symptoms or conditions are excluded:
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: NCT00002164
Locations Show More
|United States, California|
|UCLA School of Medicine / Dept of Pediatrics|
|Los Angeles, California, United States, 90024|
Sponsors and CollaboratorsAgouron Pharmaceuticals
|Responsible Party:||Agouron Pharmaceuticals|
|ClinicalTrials.gov Identifier:||NCT00002164 History of Changes|
|Other Study ID Numbers:||259E|
|Study First Received:||November 2, 1999|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Biological Availability
HIV Protease Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on January 28, 2020
This information is provided by ClinicalTrials.gov.