AEGiS-15IAC: Anrs 106- Window: A prospective, randomized, multicenter trial of intermittent therapy in HIV-infected patients with successful viral suppression under HAART.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Anrs 106- Window: A prospective, randomized, multicenter trial of intermittent therapy in HIV-infected patients with successful viral suppression under HAART.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. WeOrB1285)

Marchou B, Molina JM, Tangre P, Charreau I, Gueguen S, Ragnaud JM, Katlama C, May T, Girard PM, Morlat P, Aboulker JP; Hosp Purpan, Toulouse, France

BACKGROUND: Lifelong HAART associated-toxicity is a real concern. ANRS 106 - WINDOW trial compares 2 strategies: intermittent vs continuous HAART. OBJECTIVE: To assess the safety of intermittent therapy (IT: 6 cycles alternating 8 weeks-off, 8 weeks-on HAART) versus continuous therapy (CT) for a 96-week period. Study design: Ongoing multicenter, open label, randomized clinical trial.

METHODS: A non-inferiority trial that will compare time and cumulative progression rates to a confirmed CD4-cell count decrease to< 300/mm³ (primary end-point) between the 2 arms over a 96-week (w) period. Secondary endpoints include plasma viral load (pVL), resistance, safety, clinical lipodystrophy, quality of life, and cost-effectiveness.403 pts with chronic HIV infection, stable HAART, pVL< 400 cp/ml and CD4 count >450/mm³ for >6 months and nadir CD4 count >100/ mm3, were eligible and randomized into the study from december 2001 to june 2003. Clinical parameters, pVL, CD4 count are being monitored every 8 w. A DSMB will monitor the trial, including viral resistance data, at regular intervals. Blind interim results: 203 pts were randomized in CT group, 200 in IT group. Eleven pts withdrew consent before or at w0 and 11 after w0. Baseline characteristics (392 pts) are: median CD4 count 740/mm³ (IQR 605-915), median CD4 nadir 285/mm³ (IQR 206-371), efavirenz-based regimens 42%. Median follow-up is 65 weeks: 319 pts reached w48 and 122 pts w80. The principal events were recorded as followed: primary end-point: 2; acute retroviral syndrome: 3; AIDS-defining event: 0; death: 1; thrombocytopenia >grade2: 13.

CONCLUSIONS: After a median follow-up of 65 weeks the 8w-on/8w-off IT strategy appears to be immunologically safe. Final results after a 96 week follow-up are expected in april 2005.

Keywords: AEGIS, Antiretroviral Therapy, Highly Active, Acquired Immunodeficiency Syndrome, HIV, HIV Seropositivity, CD4 Lymphocyte Count, HIV Infections, Viral Load, HIV-1, Anti-HIV Agents, Multicenter Studies, Drug Therapy, Combination, HIV Protease Inhibitors, Clinical Trials, Humans, therapy, virology, pathogenicity, drug therapy

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WeOrB1285