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Preliminary experiences with triple therapy including nelfinavir and two reverse transcriptase inhibitors in
M B Funk1, R Linde, U Wintergerst
1Children's Hospital, Johann Wolfgang Goethe-University Frankfurt, Germany.
Insights
Triple antiretroviral therapy effectively reduced viral load and increased CD4 cell counts in HIV-infected children. Both treatment regimens were well-tolerated, showing sustained viral load reduction over 12 months.
Area of Science:
- Pediatric Infectious Diseases
- Virology
- Immunology
Background:
- Human Immunodeficiency Virus (HIV) infection in children requires effective antiretroviral therapy.
- Previously treatment-naive pediatric patients present unique challenges in managing HIV.
- Assessing the efficacy and safety of triple antiretroviral therapy is crucial for improving outcomes.
Purpose of the Study:
- To evaluate the increase in CD4 cell count and reduction in viral load in HIV-infected children on triple therapy.
- To assess clinical benefits and adverse reactions associated with antiretroviral triple therapy in pediatric patients.
- To compare two different triple antiretroviral regimens in treatment-naive children.
Main Methods:
- An intent-to-treat study followed 16 HIV-infected children for 12 months.
- Patients received either zidovudine, lamivudine, and nelfinavir, or stavudine, didanosine, and nelfinavir.
- Viral load and CD4 cell counts were monitored regularly; plasma nelfinavir levels were assessed.
Main Results:
- Both regimens achieved a median viral load reduction of 2.8 log10 over 12 months.
- After 12 months, 69% of patients had viral load < 500 copies/ml, and 44% had viral load < 50 copies/ml.
- Median CD4 cell count increased significantly and was maintained; common side effects included diarrhea, rash, and hyperlipidemia.
Conclusions:
- Triple antiretroviral therapy demonstrates potent and sustained viral load reduction in HIV-infected children.
- The observed efficacy surpasses that of therapies combining only two nucleoside analogues.
- Good compliance is essential, requiring appropriate infant formula and counseling.
Objective:
In an intent-to-treat study increase in CD4 cell count, reduction of viral load, clinical benefit and adverse reactions were examined in HIV-infected previously treatment-naive children taking triple therapy.
Methods:
sixteen HIV-infected children in category A or B on antiretroviral triple therapy were followed-up for a period of 12 months. In group I eight patients received zidovudine, lamivudine and nelfinavir; in group II eight patients received stavudine, didanosine and nelfinavir. Viral load and CD4 cell count were measured every 4-8 weeks. Plasma nelfinavir levels were assessed once in all patients at baseline and monitored in patients with increasing viral load.
Results:
No significant differences were observed between treatment groups in terms of CD4 cell counts and viral load. A median viral load reduction of 2.8 log10 (range, 1.4-4.2 log10) was achieved over a period of 12 months in both groups. Viral load < 500 copies/ml was found in 69% of patients and viral load < 50 copies/ml in 44% of patients after 12 months. Median CD4 cell count increased from 656 x 10(6) to 850 x 10(6) cells/l after 3 months and was maintained at 813 x 10(6) cells/l after 12 months of treatment. Main side-effects were diarrhoea, rash and hyperlipidaemia. Except for application problems, both regimens were well tolerated. Appropriate formula and individual counselling must be performed during the first weeks of treatment in order to achieve good compliance in paediatric patients.
Conclusion:
Triple antiretroviral therapy shows a stronger and more sustained reduction of viral load in HIV-infected children compared with studies combining two nucleoside analogues.