AEGiS-15IAC: Progress report on a structured treatment interruption (STI) trial: Trivacan ANRS 1269 trial, Abidjan, Cote d'Ivoire.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

Progress report on a structured treatment interruption (STI) trial: Trivacan ANRS 1269 trial, Abidjan, Cote d'Ivoire.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. WeOrB1284)

Danel C, Moh R, Sorho S, Anzian A, Abo Y, Chenal H, Kanga C, Eholie S, Sauvageot D, Gabillard D, Rouet F, Bissagnene E, Anglaret X, Salamon R
Programme PACCI, Abidjan, Cote d'Ivoire

BACKGROUND: Several trials are currently assessing the benefits and risks of successful antiretroviral STI, most of them in industrialised countries. We report here the progress of a multicentric randomised STI trial which was started in Abidjan in Decembre 2002.

METHODS: In the Trivacan trial, 840 antiretroviral naïve adults are first planed to receive a standardized continuous HAART. After >6 months of follow-up, patients with CD4 >350/mm³ and undetectable viral load are randomised into three arms: (i) continuous HAART, (ii) fixed STI cycles of 2-month treatment interruption followed by 4-month retreatment and (iii) unfixed STI cycles with CD4 cell count-guided retreatment and treatment reinterruption.

RESULTS: As of December, 20 2003, 696 adults (74% women, median CD4 count 247/mm³, median viral load 5.02 log10/mm³) have been included (initial HAART regimen: 87% AZT-3TC-efavirenz, 13% AZT-3TC-ritonavir-indinavir) and then followed up during 395 patient-years (median 7 months). 8 patients died, a survival probability of 0.988 at 9 months (CI 95% 0.979-0.996). The initial HAART regimen was modified in 3 patients for treatment failure and in 40 for severe drug intolerance (digestive symptoms 26, anaemia 14, dizziness 1). Of the 447 patients followed-up >6 months, 96% attended the 6-month visit, of whom 55% met the randomisation criteria. Of the 167 patients followed-up >9 months, 92% attended the 9-month visit, of whom 50% had already been randomised at 6 months and 17% met the randomisation criteria at 9 months. The 184 patients already randomised have been followed a median of 1.6 month after randomisation.

CONCLUSIONS: The inclusion rhythm, the follow-up (with low mortality rate) in the pre-randomisation phase, and the percentage of patients eligible for randomisation between 6 and 9 months are good. In July 2004, data on about 450 randomised patients followed up a median 5.5 months after randomisation will be available.

Keywords: AEGIS, Viral Load, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Indinavir, Ritonavir, Drug Therapy, Combination, Treatment Failure, Cote d'Ivoire, Humans, Female, Adult, therapy, drug therapy

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