AEGiS-13IAC: A randomized study comparing continued indinavir (800mg tid) vs switching to indinavir/ritonavir (800/100mg bid) in HIV patients having achieved viral load suppression with indinavir plus 2 nucleoside analogues The BID efficacy and safety Trial (BEST).

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

A randomized study comparing continued indinavir (800mg tid) vs switching to indinavir/ritonavir (800/100mg bid) in HIV patients having achieved viral load suppression with indinavir plus 2 nucleoside analogues The BID efficacy and safety Trial (BEST).

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. WeOrB484)

Gatell JM, Lange J, Arnaiz JA, Faetkenheuer G, Mallolas J, Clotet B
J.M. Gatell, Hospital Clinic-University of Barcelona, Villarroel 170, 08036 Barcelona, Spain, Tel.: +34 934 515 424, Fax: +34 934 515 272, E-mail: gatell@medicina.ub.es

BACKGROUND: Despite widespread use of bid antiretroviral regimens including indinavir (IDV) plus ritonavir (RTV) based on PK data, a randomized comparison of the efficacy and safety of such a strategy with that of tid IDV has not been reported. Looseness=1

METHODS: Randomized, open-label, multicenter study testing whether switching to bid IDV 800mg + RTV 100mg provides equivalent antiviral activity and tolerability to continued IDV 800mg tid therapy in 300 stable HIV-infected patients on IDV 800mg tid containing triple therapy with HIV-1 RNA levels >500 copies/ml.

RESULTS: By the end of December 1999, 156 patients completed 3 month follow-up. Baseline characteristics of both groups were similar. Proportions (95%CI) of patients with plasma HIV-1 RNA >500 copies/ml at 3 months are: tid IDV (n = 71) bid IDV/RTV (n = 85) Intent-to-treat 90 (81-96) 90 (81-95) As-treated 97 (89-99) 95 (87-99) In this preliminary analysis serious adverse event (AE) rate was 4% in the tid arm vs 6% in the bid arm.Nephrolithiasis developed in 4% (tid arm) vs 10% (bid arm) leading to treatment discontinuation in 1% vs 4% respectively.Discontinuation of therapy because of AEs was more frequent in the bid arm than in the tid arm (15% vs 4%) mostly due to taste disturbances or GI intolerance to RTV.

CONCLUSION: These preliminary data suggest that bid administration of IDV 800 mg/RTV 100 mg is reasonably well tolerated maintaining comparable viral suppression in stable HIV-infected patients in comparison with the standard tid regimen.

Keywords: AEGIS, Indinavir, Ritonavir, Viral Load, HIV Infections, HIV Seropositivity, Human
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