Preliminary experiences with triple therapy including nelfinavir and two reverse transcriptase inhibitors in previously untreated HIV-infected children.

Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

Preliminary experiences with triple therapy including nelfinavir and two reverse transcriptase inhibitors in previously untreated HIV-infected children.

AIDS. 1999 Sep 10;13(13):1653-8. Unique Identifier : AIDSLINE MED/99437265
Funk MB; Linde R; Wintergerst U; Notheis G; Hoffmann F; Schuster T; Kornhuber B; Ahrens P; Kreuz W; Children's Hospital, Johann Wolfgang Goethe-University Frankfurt,; Germany.

Abstract: 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.

Keywords: CLINICAL TRIAL JOURNAL ARTICLE Anti-HIV Agents/ADVERSE EFFECTS/*THERAPEUTIC USE Child Child, Preschool CD4 Lymphocyte Count Didanosine/ADMINISTRATION & DOSAGE Drug Therapy, Combination Female Human HIV Infections/*DRUG THERAPY/IMMUNOLOGY/VIROLOGY Infant Lamivudine/ADMINISTRATION & DOSAGE Male Nelfinavir/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ PHARMACOKINETICS Prospective Studies Reverse Transcriptase Inhibitors/ADVERSE EFFECTS/*THERAPEUTIC USE Stavudine/ADMINISTRATION & DOSAGE Support, Non-U.S. Gov't Viral Load Zidovudine/ADMINISTRATION & DOSAGE

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