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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.

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   

U.S. FDA Resources

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

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

Estimated Enrollment:   36

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


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

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

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Disease Progression
Adefovir dipivoxil
Nelfinavir
Adefovir
Retroviridae Infections
Carnitine
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Vitamins
Lentivirus Infections
Micronutrients
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 15, 2008




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