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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
Information provided by:
NIH AIDS Clinical Trials Information Service Identifier:
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1999
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:

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.

Ages Eligible for Study:   3 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002219

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 Identifier: NCT00002219     History of Changes
Other Study ID Numbers: 232H
Study First Received: November 2, 1999
Last Updated: June 23, 2005

Keywords provided by NIH AIDS Clinical Trials Information Service:
Dose-Response Relationship, Drug
Antiviral Agents
HIV Protease Inhibitors
Disease Progression
RNA, Viral
Viral Load
Age Factors

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 dipivoxil
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 processed this record on September 20, 2017