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Title: Treatment With Saquinavir Plus Kaletra (Lopinavir/Ritonavir) Appears to Benefit HIV-Positive Children: Presented at CROI

"Treatment With Saquinavir Plus Kaletra (Lopinavir/Ritonavir) Appears to Benefit HIV-Positive Children: Presented at CROI"

By Jerry Ingram BOSTON, MA -- February 28, 2005 -- Results of a pilot study suggest that treatment with saquinavir and Kaletra (lopinavir/ritonavir) benefits HIV-positive children previously treated with reverse transcriptase inhibitors (RTIs). The combination of these 2 medications reduced HIV RNA, significantly improved CD4 percent, weight, and height, researchers said. Lead investigator Jantanat Ananworanich, MD, lead investigator with the HIV-Netherlands, Australia, Thailand Research Collaboration, in Bangkok, Thailand, presented the findings here on February 23[^rd at the 12^th Conference on Retroviruses and Opportunistic Infections.

For this single-arm, open-label, prospective study, Dr. Ananworanich and colleagues enrolled 20 children who had been pretreated with an RTI for a 24-week trial. The children received lopinavir/ritonavir 230/57.5 mg/m twice daily provided primarily as adult capsules (lopinavir 133/ ritonavir 33 mg) but supplemented with oral solution of lopinavir/ritonavir 80/20 mg/mL as needed, they reported.

Saquinavir was added at a dose of 50 mg/kg twice/day as 200-mg hard-gel capsules and lamivudine was also added for those who had not taken it previously. Each week the researchers summarized HIV RNA levels using the intent-to-treat missing equals failure method.

Investigators found that HIV RNA levels dropped from baseline by -2.5 log10 copies/mL (interquartile range -2.9 to -1.9; P <.001). Eighty percent of the children in the study had HIV RNA levels suppressed below 400 copies/mL and 60% had levels below 50 copies/mL.

Four patients had HIV RNA levels greater than 400 copies/mL; however, the investigators believe this was related to poor adherence in 3 of the patients and ongoing mycobacterium tuberculosis in 1 patient.

The researchers also observed a median increase in patients' body weight of 1.5 kg during the treatment period (P =.002) and in height of 2 cm. Median CD4 counts also rose by 216 cells at week 24 (P <.001).

Treatment with saquinavir/lopinavir/ritonavir significantly improved CD4 counts, weight, and height in children who are previously treated with RTIs and provided reductions in HIV RNA, Dr. Ananworanich concluded.

[Presentation title: Pharmacokinetics and 24 Week Efficacy/Safety of Saquinavir/Lopinavir/Ritonavir in RTI Pre-Treated Children. Abstract 768]

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