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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 1999 by NIH AIDS Clinical Trials Information Service. Recruitment status was Active, not recruiting

First Received on November 2, 1999. Last Updated on 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:	Endpoint Classification: Safety Study 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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/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
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
Bronx, New York, United States, 10457
North Shore Univ Hosp / Division of Immunology
Great Neck, New York, United States, 11021
St Lukes Roosevelt Hosp Ctr
New York, New York, United States, 10025
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

ClinicalTrials.gov Identifier:	NCT00002219 History of Changes
Other Study ID Numbers:	232H, GS-97-418
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Carnitine
Adefovir dipivoxil
Adefovir
Nelfinavir

HIV Protease Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on February 12, 2012