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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Adefovir Adefovir dipivoxil Nelfinavir Nelfinavir Mesylate Carnitine

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

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.

Eligibility

Ages Eligible for Study:	3 Months to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002219

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

Sponsors and Collaborators

Gilead Sciences

More Information

No publications provided

Study ID Numbers:	232H, GS-97-418
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002219 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Dose-Response Relationship, Drug
Antiviral Agents
HIV Protease Inhibitors
Disease Progression
RNA, Viral

Adenine
Viral Load
Age Factors
Nelfinavir

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Vitamins
Therapeutic Uses
Micronutrients
Nelfinavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors

RNA Virus Infections
Anti-HIV Agents
Vitamin B Complex
Immune System Diseases
Growth Substances
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 09, 2009