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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. The completion date has passed and the status has not been verified in more than two years.

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

Sponsor:

ClinicalTrials.gov Identifier:

NCT00002219

First Posted: August 31, 2001

Last Update Posted: December 9, 2005

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

NIH AIDS Clinical Trials Information Service

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 2


Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Adefovir dipivoxil Nelfinavir Nelfinavir Mesylate

U.S. FDA Resources

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	3 Months to 16 Years (Child)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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


ClinicalTrials.gov Identifier:	NCT00002219 History of Changes
Other Study ID Numbers:	232H GS-97-418
First Submitted:	November 2, 1999
First Posted:	August 31, 2001
Last Update Posted:	December 9, 2005
Last Verified:	November 1999

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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Adefovir Adefovir dipivoxil	Nelfinavir Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents

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