1st International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 26–28 June 1999 - San Diego, CA, USA

A MULTICENTRE, RANDOMIZED, OPEN-LABEL, COMPARATIVE TRIAL OF THE CLINICAL, IMMUNOLOGICAL AND VIROLOGICAL BENEFIT OF SWITCHING THE PI BY NEVIRAPINE IN HAART-EXPERIENCED PATIENTS SUFFERING LIPODYSTROPHY

Antiviral Therapy 1999; 4(Suppl. 2):50(abstract no. 31)

L Ruiz¹, E Negredo¹, A Bonjoch¹, R Paredes¹, J Romeu¹, G Sirera¹, RC Fumaz¹, L Zamora² and B Clotet¹ for the LD Study Group
¹irsiCaixa Foundation, Hospital University Germans Trias i Pujol, Badalona, Barcelona; and ²Medical Department, Bristol Myers-Squibb, Madrid, Spain

OBJECTIVES: To evaluate the clinical, biochemical, immunological and virological impact of switching a PI to nevirapine in HAART-experienced patients suffering lipodystrophy (LD) with long-lasting plasma HIV suppression.

DESIGN: An open-label randomized multicentre study.

METHODS: Eligible patients had to have been on the same combination (stavudine/lamivudine/1 PI) for at least 9 months, maintaining HIV-1 RNA load <400 copies/ml for at least 6 months. Patients were randomized to stavudine/didanosine/nevirapine (Group 1) or stavudine/lamivudine/1 PI (Group 2). Plasma viral load (pVL), CD4 count, triglycerides (TG) and cholesterol (CHOL) changes were determined at baseline (BL) and every 3 months.

RESULTS: At week 12: 64/94 patients completed the 12 weeks of the study. Two patients had adverse events in Group 1 (1 rash and 1 hepatitis). Two patients in each group had viral rebound (patients in nevirapine group were non-compliant). 56/64 patients had pVL <50 copies/ml at BL which was sustained at week 12 in all of them. In 12/32 (38%) patients from Group 1 and in 6/24 (25%) patients from Group 2, pVL diminished to <5 copies/ml. CD4 cell counts did not significantly change in either group at week 12. In Group 1, CHOL diminished significantly with respect to the BL values (230±46 to 196±54; P<0.05). 10/14 patients from Group 1 and 2/13 from Group 2 normalized their CHOL levels (<200 mg/dl; P<0.05) at week 12. TG levels decreased to normal levels (<150 mg/dl) in 9/15 patients from Group 1 and 1/15 from Group 2 (P<0.05). Quality of life and both physician's and patient's estimation of body shape changes improved significantly in the nevirapine group.

CONCLUSIONS: After 12 weeks, patients on HAART with LD and undetectable plasma VL who switched to didanosine/stavudine/nevirapine maintained HIV-1 suppression, reduced CHOL and TG levels and improved quality of life and self-perception of LD changes.

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