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| ID | Type | Description | Link |
|---|---|---|---|
| GS-97-418 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfinavir mesylate | Drug | |||
| Levocarnitine | Drug | |||
| Adefovir dipivoxil | Drug |
Inclusion Criteria
Your child may be eligible for this study if he/she:
Exclusion Criteria
Your child will not be eligible for this study if he/she:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| All Children's Hosp | St. Petersburg | Florida | 33731 | United States | ||
| Tulane Univ Med Ctr / Dept of Pediatrics |
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| 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 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019888 | Nelfinavir |
| D002331 | Carnitine |
| C106812 | adefovir dipivoxil |
| ID | Term |
|---|---|
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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