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

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.
ClinicalTrials.gov Identifier: NCT00002219
Recruitment Status : Unknown
Verified November 1999 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Nelfinavir mesylate Drug: Levocarnitine Drug: Adefovir dipivoxil Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources





Information from the National Library of Medicine

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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.

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

ClinicalTrials.gov Identifier: NCT00002219     History of Changes
Other Study ID Numbers: 232H
GS-97-418
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 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