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| Sponsored by: |
Gilead Sciences |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002219 |
Purpose
The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Nelfinavir mesylate Drug: Levocarnitine Drug: Adefovir dipivoxil |
Phase II |
| MedlinePlus related topics: | AIDS |
| ChemIDplus related topics: | Nelfinavir Nelfinavir Mesylate Adefovir dipivoxil Adefovir Carnitine Adenine |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| Official Title: | A Phase I/II, Open-Label, Multi-Center Study of the Pharmacokinetics, Safety, Tolerance and Activity of Two Dose Levels of Adefovir Dipivoxil (ADF) and Nelfinavir When Added to Antiretroviral Therapy for the Treatment of HIV-Infected Pediatric Patients |
| Estimated Enrollment: | 36 |
During the first phase of the study (Days 1-6), the safety and tolerability of multiple doses of ADF is assessed when administered simultaneously with the patient's reverse transcriptase inhibitor (RTI) regimen. The second phase begins on Day 7 when nelfinavir is added to the therapy regimen for an additional 15 weeks. ADF pharmacokinetics are measured on Days 1, 2, and 7 (on a subset of 18 patients); peak and trough samples are collected on Day 28.
Eligibility
| Ages Eligible for Study: | 3 Months to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Your child may be eligible for this study if he/she:
Exclusion Criteria
Your child will not be eligible for this study if he/she:
Contacts and Locations| United States, Florida | |||||
| All Children's Hosp | |||||
| St. Petersburg, Florida, United States, 33731 | |||||
| United States, Louisiana | |||||
| Tulane Univ Med Ctr / Dept of Pediatrics | |||||
| New Orleans, Louisiana, United States, 70112 | |||||
| United States, New York | |||||
| St Lukes Roosevelt Hosp Ctr | |||||
| New York, New York, United States, 10025 | |||||
| North Shore Univ Hosp / Division of Immunology | |||||
| Great Neck, New York, United States, 11021 | |||||
| Bronx Lebanon Hosp Ctr / Dept of Pediatrics | |||||
| Bronx, New York, United States, 10457 | |||||
| United States, North Carolina | |||||
| Duke Univ Med Ctr / Duke South Hosp | |||||
| Durham, North Carolina, United States, 27710 | |||||
| United States, South Carolina | |||||
| Med Univ of South Carolina | |||||
| Charleston, South Carolina, United States, 29425 | |||||
| Gilead Sciences |
More Information
| Study ID Numbers: | 232H, GS-97-418 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002219 |
| Health Authority: | United States: Food and Drug Administration |
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