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| ID | Type | Description | Link |
|---|---|---|---|
| 10194 | Registry Identifier | DAIDS ES |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
The way abacavir (ABC) behaves in the body differs between children and adults, but little is known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for adolescents. The purpose of this study is to determine the blood levels of ABC in HIV infected adolescents who are on ABC-containing regimens.
ABC is approved for the treatment of HIV in adults and children, but it is unclear if currently recommended ABC doses are appropriate for adolescents. Previous data suggest ABC clearance in children is about twice that found in adults, but limited data exist on the pharmacokinetics of ABC in adolescents. This study will evaluate the 8-hour pharmacokinetics of ABC in HIV infected adolescents who are currently on ABC-containing treatment regimens.
There will be two groups in this study. Group 1 participants will be 13 to 17 years old. Group 2 participants will be 18 to 25 years old. All participants will receive a 300 mg dose of ABC as either a single-agent tablet or a combination tablet of ABC, lamivudine, and zidovudine (whichever they are currently taking). Participants will have a medical history assessment and a physical exam at screening and study entry. Participants will also be asked about adherence to their ABC-containing regimen at study entry. During the 8-hour drug level study, blood collection for pharmacokinetic analysis will occur prior to taking ABC, and at 0.5, 1, 2, 3, 4, 6, and 8 hours after taking ABC.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abacavir sulfate | Drug | |||
| Abacavir sulfate, lamivudine, and zidovudine | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Rodman, PharmD | St. Jude's Children's Research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Usc La Nichd Crs | Alhambra | California | 91803 | United States | ||
| Children's Hospital of Los Angeles NICHD CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10453964 | Background | Chittick GE, Gillotin C, McDowell JA, Lou Y, Edwards KD, Prince WT, Stein DS. Abacavir: absolute bioavailability, bioequivalence of three oral formulations, and effect of food. Pharmacotherapy. 1999 Aug;19(8):932-42. doi: 10.1592/phco.19.11.932.31568. | |
| 10049275 | Background | Hughes W, McDowell JA, Shenep J, Flynn P, Kline MW, Yogev R, Symonds W, Lou Y, Hetherington S. Safety and single-dose pharmacokinetics of abacavir (1592U89) in human immunodeficiency virus type 1-infected children. Antimicrob Agents Chemother. 1999 Mar;43(3):609-15. doi: 10.1128/AAC.43.3.609. |
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| Los Angeles |
| California |
| 90027 |
| United States |
| UCSD Mother-Child-Adolescent Program CRS | San Diego | California | 92103 | United States |
| Children's National Med. Ctr. Washington DC NICHD CRS | Washington D.C. | District of Columbia | 20010 | United States |
| Children's National Med. Ctr., ACTU | Washington D.C. | District of Columbia | 20010 | United States |
| Univ. of Florida Jacksonville NICHD CRS | Jacksonville | Florida | 32209 | United States |
| USF - Tampa NICHD CRS | Tampa | Florida | 33606 | United States |
| Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases | Augusta | Georgia | 30912 | United States |
| Chicago Children's CRS | Chicago | Illinois | 60614 | United States |
| Tulane/LSU Maternal/Child CRS | New Orleans | Louisiana | 70112 | United States |
| HMS - Children's Hosp. Boston, Div. of Infectious Diseases | Boston | Massachusetts | 02115 | United States |
| Baystate Health, Baystate Med. Ctr. | Springfield | Massachusetts | 01199 | United States |
| Children's Hospital of Michigan NICHD CRS | Detroit | Michigan | 48201 | United States |
| UMDNJ - Robert Wood Johnson Med. School, Div. of Allergy, Immunology & Infectious Diseases | New Brunswick | New Jersey | 08901 | United States |
| Rutgers - New Jersey Medical School CRS | Newark | New Jersey | 07103 | United States |
| Columbia IMPAACT CRS | New York | New York | 10032 | United States |
| Bronx-Lebanon Hosp. IMPAACT CRS | The Bronx | New York | 10457 | United States |
| UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases | Chapel Hill | North Carolina | 27599 | United States |
| St. Jude/UTHSC CRS | Memphis | Tennessee | 38105 | United States |
| San Juan City Hosp. PR NICHD CRS | San Juan | 00936 | Puerto Rico |
| 10103339 | Background | Kline MW, Blanchard S, Fletcher CV, Shenep JL, McKinney RE Jr, Brundage RC, Culnane M, Van Dyke RB, Dankner WM, Kovacs A, McDowell JA, Hetherington S. A phase I study of abacavir (1592U89) alone and in combination with other antiretroviral agents in infants and children with human immunodeficiency virus infection. AIDS Clinical Trials Group 330 Team. Pediatrics. 1999 Apr;103(4):e47. doi: 10.1542/peds.103.4.e47. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
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| ID | Term |
|---|---|
| C106538 | abacavir |
| D019259 | Lamivudine |
| D015215 | Zidovudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D013936 | Thymidine |
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