Back to resultsSafety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
Primary Purpose
HIV Infections
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nelfinavir mesylate
Levocarnitine
Adefovir dipivoxil
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Dose-Response Relationship, Drug, Antiviral Agents, HIV Protease Inhibitors, Disease Progression, RNA, Viral, Adenine, Viral Load, Age Factors, Nelfinavir
Eligibility 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.
Sites / Locations
- All Children's Hosp
- Tulane Univ Med Ctr / Dept of Pediatrics
- Bronx Lebanon Hosp Ctr / Dept of Pediatrics
- North Shore Univ Hosp / Division of Immunology
- St Lukes Roosevelt Hosp Ctr
- Duke Univ Med Ctr / Duke South Hosp
- Med Univ of South Carolina
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002219
Brief Title
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 1999
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gilead Sciences
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Dose-Response Relationship, Drug, Antiviral Agents, HIV Protease Inhibitors, Disease Progression, RNA, Viral, Adenine, Viral Load, Age Factors, Nelfinavir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Levocarnitine
Intervention Type
Drug
Intervention Name(s)
Adefovir dipivoxil
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
All Children's Hosp
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33731
Country
United States
Facility Name
Tulane Univ Med Ctr / Dept of Pediatrics
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
North Shore Univ Hosp / Division of Immunology
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
St Lukes Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Duke Univ Med Ctr / Duke South Hosp
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
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