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Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Twice daily | Active Comparator |
| |
| Once daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABC Twice Daily | Drug |
| ||
| ABC Once Daily |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) of lamivudine after qd and bid dosing | week 0 and Week 4 | |
| Cmin of lamivudine after qd and bid dosing | week 0 and week 4 | |
| Cmax of lamivudine after qd and bid dosing | week 0 and week 4 | |
| AUC of abacavir after qd and bid dosing | week 0 and week 4 | |
| Cmin of abacavir after qd and bid dosing | week 0 and week 4 | |
| Cmax of abacavir after qd and bid dosing | week 0 and week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| To describe trough intracellular levels of 3TC on twice daily and once daily dosage regimens | Week 0 and week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| To describe patient and family acceptability of and adherence to once daily compared to twice daily dosing | week -2 and week 24 |
Inclusion Criteria:
Exclusion Criteria:
• Intercurrent illness
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| Name | Affiliation | Role |
|---|---|---|
| Vas Novelli, MD | Great Ormond Street Hospital for Children, London, UK | Principal Investigator |
| Hermione Lyall, MD | St. Mary's Hospital, London, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormond Street Hospital | London | United Kingdom | ||||
| St. Mary's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15865218 | Background | Bergshoeff A, Burger D, Verweij C, Farrelly L, Flynn J, Le Prevost M, Walker S, Novelli V, Lyall H, Khoo S, Gibb D; PENTA-13 Study Group. Plasma pharmacokinetics of once- versus twice-daily lamivudine and abacavir: simplification of combination treatment in HIV-1-infected children (PENTA-13). Antivir Ther. 2005;10(2):239-46. | |
| 16732152 |
| Label | URL |
|---|---|
| PENTA 13 publications and presentations | View source |
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|
| 3TC Once Daily | Drug |
|
| 3TC Twice Daily | Drug |
|
| London |
| United Kingdom |
| LePrevost M, Green H, Flynn J, Head S, Clapson M, Lyall H, Novelli V, Farrelly L, Walker AS, Burger DM, Gibb DM; Pediatric European Network for the Treatment of AIDS 13 Study Group. Adherence and acceptability of once daily Lamivudine and abacavir in human immunodeficiency virus type-1 infected children. Pediatr Infect Dis J. 2006 Jun;25(6):533-7. doi: 10.1097/01.inf.0000222415.40563.d4. |
| 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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