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
Recruitment status was Active, not recruiting
Sponsor:
Gilead Sciences
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
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Purpose
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: | Endpoint Classification: Safety Study 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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Carnitine
Levocarnitine
Adefovir dipivoxil
Nelfinavir
Nelfinavir Mesylate
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| Estimated Enrollment: | 36 |
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.
Eligibility| Ages Eligible for Study: | 3 Months to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002219
Locations
| 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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002219 History of Changes |
| Other Study ID Numbers: | 232H, GS-97-418 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Dose-Response Relationship, Drug Antiviral Agents HIV Protease Inhibitors Disease Progression RNA, Viral |
Adenine Viral Load Age Factors Nelfinavir |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Carnitine Adefovir Adefovir dipivoxil Nelfinavir |
HIV Protease Inhibitors Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on May 23, 2013