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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002219
• Other study ID #: 232H
• Secondary ID: GS-97-418
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 16 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Nelfinavir mesylate

• Levocarnitine

• Adefovir dipivoxil

Locations

Country	Name	City	State
United States	Bronx Lebanon Hosp Ctr / Dept of Pediatrics	Bronx	New York
United States	Med Univ of South Carolina	Charleston	South Carolina
United States	Duke Univ Med Ctr / Duke South Hosp	Durham	North Carolina
United States	North Shore Univ Hosp / Division of Immunology	Great Neck	New York
United States	Tulane Univ Med Ctr / Dept of Pediatrics	New Orleans	Louisiana
United States	St Lukes Roosevelt Hosp Ctr	New York	New York
United States	All Children's Hosp	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States,