Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00002219 |
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Recruitment Status : Unknown
Verified November 1999 by NIH AIDS Clinical Trials Information Service.
Recruitment status was: Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Sponsor:
Gilead Sciences
Information provided by:
NIH AIDS Clinical Trials Information Service
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Nelfinavir mesylate Drug: Levocarnitine Drug: Adefovir dipivoxil | Phase 2 |
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 (Clinical Trial) |
| Enrollment : | 36 participants |
| 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 |
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| Ages Eligible for Study: | 3 Months to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
| ClinicalTrials.gov Identifier: | NCT00002219 History of Changes |
| Other Study ID Numbers: |
232H GS-97-418 |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | November 1999 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
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Dose-Response Relationship, Drug Antiviral Agents HIV Protease Inhibitors Disease Progression RNA, Viral |
Adenine Viral Load Age Factors Nelfinavir |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Adefovir Adefovir dipivoxil |
Nelfinavir Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents HIV Protease Inhibitors Protease Inhibitors Anti-HIV Agents |