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

Sponsor

Gilead Sciences (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00002219

Collaborator

(none)

Enrollment

Locations

5.1

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Nelfinavir mesylate Drug: Levocarnitine Drug: Adefovir dipivoxil	Phase 2

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	All Children's Hosp	St. Petersburg	Florida	United States	33731
2	Tulane Univ Med Ctr / Dept of Pediatrics	New Orleans	Louisiana	United States	70112
3	Bronx Lebanon Hosp Ctr / Dept of Pediatrics	Bronx	New York	United States	10457
4	North Shore Univ Hosp / Division of Immunology	Great Neck	New York	United States	11021
5	St Lukes Roosevelt Hosp Ctr	New York	New York	United States	10025
6	Duke Univ Med Ctr / Duke South Hosp	Durham	North Carolina	United States	27710
7	Med Univ of South Carolina	Charleston	South Carolina	United States	29425