Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children - Tabular View

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Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children

This study is ongoing, but not recruiting participants.

Study NCT00002219. Last updated on June 23, 2005. Information provided by NIH AIDS Clinical Trials Information Service

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
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
Brief Summary	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.
Detailed Description	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.
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Safety Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	HIV Infections
Intervention ^†	Drug: Nelfinavir mesylate Drug: Levocarnitine Drug: Adefovir dipivoxil
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	36
Start Date ^†
Completion Date
Eligibility Criteria ^†	Inclusion Criteria Your child may be eligible for this study if he/she: Is 3 months to 16 years old. Is HIV-positive. Has never taken protease inhibitors or has previously taken ritonavir (RTV), saquinavir (SQV), or indinavir (IDV) and is willing to stop the medication at study entry. Is taking an anti-HIV drug combination that will not change during at least the 2 weeks prior to study entry. Agrees to use effective barrier methods of birth control, such as condoms, during the study. Has consent of parent or guardian. Exclusion Criteria Your child will not be eligible for this study if he/she: Has ever taken NFV. Has a history of opportunistic (AIDS-related) infection. Has any disease or illness that would prevent him/her from completing the study, including cancer. Has taken certain medications, including protease inhibitors at study entry. Is receiving an HIV vaccine at study entry. Is pregnant.
Gender	Both
Ages	3 Months to 16 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00002219
Organization ID	232H
Secondary IDs ^††	GS-97-418
Study Sponsor ^†	Gilead Sciences
Collaborators ^††
Investigators ^†
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	November 1999
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.