AEGiS-15IAC: E-184V. Pilot study to evaluate immunological response to lamivudine monotherapy vs treatment interruption in failing HIV-1 infected subjects, harbouring the M184V mutation.

15th International AIDS Conference

Bangkok, Thailand - July 11-16, 2004

E-184V. Pilot study to evaluate immunological response to lamivudine monotherapy vs treatment interruption in failing HIV-1 infected subjects, harbouring the M184V mutation.

Int Conf AIDS 2004 Jul 11-16; 15:(abstract no. WeOrB1286)

Castagna A, Danise A, Carini E, Boeri E, Galli L, Gianotti N, De Bona A, Hasson H, Guffanti M, Seminari E, Clementi M, Lazzarin A
Clinic of Infectious Diseases, Vita-Salute San Raffaele University, Milan, Italy

BACKGROUND: The M184V mutation, frequently selected by lamivudine (3TC), seems to reduce viral fitness and so its maintenance by means of sustained drug pressure may delay immunological failure (IF). The aim of Experienced-184V (E-184V) study is to assess the frequency of IF (CD4<350 cells/muL) in failing pts with the M184V mutation, who stop treatment or receive 3TC monotherapy.

METHODS: This ongoing prospective, open-label, 48-week pilot study will randomise (1:1) 50 pts on 3TC containing HAART, requesting treatment interruption, HBV negative, with CD4>500 cells/muL and viral load (VL)>1000 cp/mL, to therapy interruption (arm A) or 3TC 300 mg QD monotherapy (arm B). Screening genotype documenting M184V mutation was performed and repeated at baseline (BL) and every three months. The data are given as median and IQRs or frequencies and percentages.

RESULTS: As of January 2004, 45/50 pts had been enrolled: 24 in arm A and 21 in arm B. Arm A and arm B BL CD4 (cells/muL) and VL (copies/mL) were 630 [562-772], 7,245 [3215-20,145], and 605 [567-704], 7,664 [2324-13,017] respectively. Two pts in both arms belonged to C CDC group.14/24 (58%) arm A and 9/21 (43%) arm B pts discontinued the study after respectively 14 [12-20] and 20 [8-24] weeks because of IF (21 pts), consent withdrawal (1 arm A pt) and oesophageal candidiasis (1 arm A pt). At week 24, CD4 and VL are available on 40/45 pts (92%), who discontinued or completed 24 weeks of follow-up (Table). [table: see text]

CONCLUSIONS: Our preliminary results support the hypothesis that 3TC monotherapy reduces the frequency of IF and induces less viral rebound than therapy interruption.

Keywords: AEGIS, Lamivudine, HIV-1, HIV-1 Reverse Transcriptase, Viral Load, Antiretroviral Therapy, Highly Active, Mutation, Pilot Projects, Antigens, CD4, Drug Therapy, Combination, therapy, immunology, genetics, drug therapy

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