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Clinical, Virological, and Immunological Benefit of Switching the Protease Inhibitor (PI) by Nevirapine (NVP) in HAART-Experienced Patients Suffering Lipodystrophy (LD): 36-Week Follow-Up L. RUIZ*1, E. NEGREDO1, P. DOMINGO2, A. BONJOCH1, R. PAREDES1, E. FRANCIA2, M. BALAGUÉ1, J. ROMEU1, A. ARNÓ1, C. R. FUMAZ1, S. JOHNSTON1, G. SIRERA1, C. TURAL1, and B. CLOTET1 for the LD Study Group.
1"irsi Caixa" Fndn. Hosp. Germans Trias i Pujol, and 2Hosp. S. Pau., Barcelona, Spain Objectives: To evaluate the clinical, biochemical, immunological and virological impact of switching the PI by NVP in HAART-experienced patients (pts) suffering lipodystrophy (LD) with long-lasting plasma HIV suppression.
Design: An open label randomized multicenter study.
Methods: Eligible pts had to have been on d4T+3TC+1PI for >9 months (mo), maintaining HIV-1 RNA load <200 copies/ml for >6 mo. Pts were randomized to Group1 (d4T+ddI+NVP) or Group2 (d4T+3TC+PI) and were assessed at screening, baseline (BL), and every 4 wks thereafter. 3TC was substituted by ddI in order to spare drugs for rescue therapy in case of virological failure. Plasma viral load (VL) was quantified every 4 wks. CD4 counts, triglycerides (TG), total cholesterol (CHOL), DEXA and anthropometric changes were determined at BL and every 3 mo. Serum lactate, lactate/piruvate ratio and free and total L-carnitine were performed in a subgroup of 35 patients to investigate mitochondrial dysfunction.
Results at week 36: 60/106 pts currently recruited (N=31, Group1; N=29, Group2) completed the 36 wk of the study. Evidence of NVP-related rash was seen in only 3 patients (0.1%) from Group1. 51/60 pts had plasma VL <50 c/ml at BL which was sustained at wk 36. Plasma VL increased above 200 c/ml in 7 pts (N=4, Group1; N=3, Group2) during the follow-up. CD4 counts significantly increased in both groups at wk 36, although no differences were observed between them. Only in Group 1, CHOL and TG diminished significantly (CHOL: 227±42 to 201±35; P< 0.05); (TG: 270±180 to 207±152). Abnormal fasting glucose (>120 mg/dl) was seen in 6 pts both at BL and at wk 24. No significant improvements in body-shape changes were observed at wk 36 in NVP group. Lactic acidaemia was detected in 1/35 (2,7 mmol/l). Quality of life improved significantly in NVP group.
Conclusions: After 36 weeks pts switching to NVP maintain HIV-1 suppression, show a continuos improvements in CD4, reduce CHOL and TG levels and improve QL. In our pts lactic acidaemia was infrequently seen.
Key Words: HIV, Lipodystrophy, Nevirapine
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