Abstract | BACKGROUND: HIV-associated encephalopathy (HIV-AE) is a severe neurologic condition that affects HIV-infected children. The potential benefit of antiretroviral (ARV) agents with good cerebrospinal fluid (CSF) penetration remains to be defined. Abacavir (ABC) achieves good CSF concentrations and studies of high-dose ABC showed benefit in adults with HIV dementia. The present study evaluated the safety and virologic, immunologic and neuropsychological responses of an ARV regimen including high-dose ABC in children with HIV-AE. METHODS: Children between 3 months and 18 years old and abacavir-naive with HIV-AE and virologic failure were eligible. RESULTS: : Seventeen children (16 ARV-experienced) were enrolled and 14 children completed 48 weeks of therapy. The overall tolerability was good; 2 children had a possible hypersensitivity reaction. At week 48, 53% and 59% of the children achieved HIV RNA levels below the limit of quantitation in plasma and CSF, respectively. The median (25%-75% range) change of HIV RNA from baseline to week 48 was -2.29 (-0.81 to -2.47) log10 copies/mL in plasma and -0.94 (0 to -1.13) log10 copies/mL in CSF. The mean increases in CD4 (+/-standard error of mean) cell count and CD4% were 427 (+/-169) cells/mm and 8% (+/-2), respectively. Concentrations of soluble tumor necrosis factor receptor II were reduced in plasma and CSF. Children less than 6 years of age demonstrated significant neuropsychological improvement at week 48. CONCLUSIONS: In the present study with a limited number of children, highly active ARV therapy including high-dose ABC showed a safety profile similar to standard dose ABC and provided clinical, immunologic and virologic response in children with HIV-AE at week 48. Children less than 6 years of age also demonstrated significant neuropsychological improvement.
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Authors | Jesús Saavedra-Lozano, José T Ramos, Francisco Sanz, M Luisa Navarro, M I de José, P Martín-Fontelos, María J Mellado, Juan A León Leal, Cecilia Rodriguez, Isabel Luque, Samuel J Madison, David Irlbeck, E Randall Lanier, Octavio Ramilo |
Journal | The Pediatric infectious disease journal
(Pediatr Infect Dis J)
Vol. 25
Issue 12
Pg. 1142-52
(Dec 2006)
ISSN: 0891-3668 [Print] United States |
PMID | 17133160
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-HIV Agents
- Dideoxynucleosides
- RNA, Viral
- Receptors, Tumor Necrosis Factor, Type II
- Reverse Transcriptase Inhibitors
- abacavir
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Topics |
- AIDS Dementia Complex
(drug therapy, immunology, psychology, virology)
- Adolescent
- Anti-HIV Agents
(administration & dosage, adverse effects, therapeutic use)
- Antiretroviral Therapy, Highly Active
- CD4 Lymphocyte Count
- CD4-CD8 Ratio
- Child
- Child, Preschool
- Dideoxynucleosides
(administration & dosage, adverse effects, therapeutic use)
- Drug Hypersensitivity
- Female
- HIV
(genetics)
- Humans
- Infant
- Male
- Pilot Projects
- RNA, Viral
(blood, cerebrospinal fluid)
- Receptors, Tumor Necrosis Factor, Type II
(blood, cerebrospinal fluid)
- Reverse Transcriptase Inhibitors
(administration & dosage, adverse effects, therapeutic use)
- Salvage Therapy
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