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
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002219
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1999

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002219 on ClinicalTrials.gov Archive Site
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Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Nelfinavir mesylate
  • Drug: Levocarnitine
  • Drug: Adefovir dipivoxil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
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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.
Both
3 Months to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002219
232H, GS-97-418
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Gilead Sciences
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NIH AIDS Clinical Trials Information Service
November 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP