What question did this study set out to answer?

To evaluate the safety, tolerability, pharmacokinetics, and preliminary antiretroviral activity of lamivudine in HIV-infected children beyond the neonatal period.

July 1, 1996The Journal of Infectious DiseasesOpen Access

Lamivudine in Children with Human Immunodeficiency Virus Infection: A Phase I/II Study

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Authors

LLLinda LewisNational Institutes of Health DVDavid VenzonSouthern Research Institute JCJarrod E. ChurchLa Trobe University

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Implication

Phase I/II trial reveals favorable tolerability and viral reduction with lamivudine in pediatric HIV infection, indicating potential utility in combination regimens.

Key Points

To evaluate the safety, tolerability, pharmacokinetics, and preliminary antiretroviral activity of lamivudine in HIV-infected children beyond the neonatal period.
Conducted a Phase I/II trial evaluating lamivudine at doses of 1 to 20 mg/kg/day in 90 HIV-infected children.
Measured drug concentrations in serum and cerebrospinal fluid and monitored CD4/CD8 cell counts, p24 antigen, and HIV RNA levels over 24 weeks.
Serum and cerebrospinal fluid concentrations increased proportionally to the administered dose.
Quantitative immune complex-dissociated p24 antigen and HIV RNA levels decreased significantly at 12 and 24 weeks, while CD4 and CD8 counts remained stable in therapy-naive children.
Treatment was discontinued in 11 children for disease progression and 10 for potential drug toxicity, with in vitro resistance detected in viral isolates from some patients by week 12.

Cite This Study

Lewis et al. (1996) studied this question.

synapsesocial.com/papers/6a86c1dccbde9db34bcb8c1d https://doi.org/10.1093/infdis/174.1.16

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Implication

Phase I/II trial reveals favorable tolerability and viral reduction with lamivudine in pediatric HIV infection, indicating potential utility in combination regimens.

Lamivudine in Children with Human Immunodeficiency Virus Infection: A Phase I/II Study

Discussion

Member takes

Implication

Key Points

Cite This Study

Lamivudine in Children with Human Immunodeficiency Virus Infection: A Phase I/II Study

Discussion

Member takes

Implication

Key Points

Cite This Study

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