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
2 other identifiers
interventional
36
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (7)
All Children's Hosp
St. Petersburg, Florida, 33731, United States
Tulane Univ Med Ctr / Dept of Pediatrics
New Orleans, Louisiana, 70112, United States
North Shore Univ Hosp / Division of Immunology
Great Neck, New York, 11021, United States
St Lukes Roosevelt Hosp Ctr
New York, New York, 10025, United States
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
The Bronx, New York, 10457, United States
Duke Univ Med Ctr / Duke South Hosp
Durham, North Carolina, 27710, United States
Med Univ of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-11