- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002219
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
June 23, 2005 updated by: Gilead Sciences
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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St. Petersburg, Florida, United States, 33731
- All Children's Hosp
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane Univ Med Ctr / Dept of Pediatrics
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New York
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Bronx, New York, United States, 10457
- Bronx Lebanon Hosp Ctr / Dept of Pediatrics
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Great Neck, New York, United States, 11021
- North Shore Univ Hosp / Division of Immunology
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New York, New York, United States, 10025
- St Lukes Roosevelt Hosp Ctr
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Univ Med Ctr / Duke South Hosp
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South Carolina
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Charleston, South Carolina, United States, 29425
- Med Univ of South Carolina
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
November 1, 1999
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Nelfinavir
- Adefovir
- Adefovir dipivoxil
Other Study ID Numbers
- 232H
- GS-97-418
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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