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Retinal toxicity in human immunodeficiency virus-infected children treated with 2',3'-dideoxyinosine
S M Whitcup1, K M Butler, R Caruso
1Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD 20892.
Insights
This study evaluated 2
Area of Science:
- Ophthalmology
- Infectious Diseases
- Pharmacology
Background:
- Human immunodeficiency virus (HIV) infection can cause ocular complications.
- 2',3'-dideoxyinosine (ddI) is an antiretroviral drug used in HIV treatment.
Purpose of the Study:
- To assess the safety and antiretroviral activity of 2',3'-dideoxyinosine in children with HIV.
- To monitor for ocular complications associated with ddI treatment or HIV infection.
Main Methods:
- A Phase I-II study enrolled 43 children with symptomatic HIV (CDC class P-2).
- Prospective monitoring for ocular complications over 12 to 103 weeks (median 71 weeks).
Main Results:
- Three of 43 children (7.0%) developed peripheral retinal pigment epithelium atrophy.
- The most severe cases occurred at the highest ddI dosage (540 mg/m2/day).
- No retinal atrophy was observed in HIV-infected adults treated with ddI.
Conclusions:
- 2',3'-dideoxyinosine treatment in children with HIV may be associated with retinal pigment epithelium atrophy.
- Dosage may influence the risk of ocular toxicity.
- Further investigation is warranted to understand the ocular safety profile of ddI in pediatric HIV patients.
Abstract:
To assess the safety and antiretroviral activity of 2',3'-dideoxyinosine, we enrolled 43 children with symptomatic (Centers for Disease Control class P-2) human immunodeficiency virus infection in a Phase I-II study and monitored them prospectively for the development of ocular complications secondary to HIV infection or drug toxicity. Follow-up ranged from 12 to 103 weeks with a median follow-up of 71 weeks. Three of 43 children (7.0%) developed peripheral atrophy of the retinal pigment epithelium during treatment with 2',3'-dideoxyinosine. The two children with the most severe retinal atrophy were enrolled in the study at the highest dosage studied (540 mg/m2/day). In contrast to findings in children, no retinal atrophy in HIV-infected adults treated with 2',3'-dideoxyinosine has been evident to date.