KNOBEL H, MIRO JM, DE-MIGUEL V, DOMINGO P, GONZALEZ A, RIVERO A, MARQUEZ M, BARRUFET P, SANZ J, BOIX V, LOCUTORA J, BLANCO J, GUARDIOLA JM, CERVANTES M, DALMAU D; Interscience Conference on Antimicrobial Agents and Chemotherapy.
Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 2000 Sep 17-20; 40: 180.
Hospital Ntra Sra del Mar, Barcelona, Spain
BACKGROUND: A double-blind placebo-controlled study was performed in order to evaluate the efficacy of prednisone in nevirapine-induced rash prevention.METHODS: Multicentered, randomized, double-blind, placebo-controlled clinical trial of prednisone (30 mg/day p.o. during 2 weeks) versus placebo. Inclusion criteria: HIV-1 infection; CD4+ cell count > 200 cells/mm3; HIV-1 RNA plasma viral load (PVL) <100,000 copies/mL; escalating dose of nevirapine (initial dose, 200 mg/day p.o. during 2 weeks, followed by 200 mg p.o. b.i.d.) plus standard doses of stavudine and didanosine. All patients received the same antiretroviral therapy and were naive for all drugs used. Clinical follow-up was performed at 2, 4 and 8 weeks. Analysis was done when all patients completed 8 weeks of therapy.RESULTS: 75 patients were enrolled in the study (39 prednisone vs 36 placebo). 81% males with a median age of 33 years. At study entry the median CD4+ cell count was 390 cells/mm3 and the median PVL was 20,200 copies/mL. No differences were found at baseline characteristics between both groups. Overall, 9 rashes (12%) were detected, 7 (18%) in the prednisone group and 2 (5.5%) in the placebo group (OR=4,46; 95% CI= 0,86-23,13; p=0.11). The overall incidence of moderate and severe rashes to cause nevirapine withdrawal was 8% (6/75), being 13% (5/39) in the prednisone group and 3% (1/36) in the placebo group (p= 0.2). Median time of rash appearance in both groups was 16 days (11-39). The overall incidence of total adverse events to motivate withdrawal of therapy was 12% (9/75), being 15% (6/39) in the prednisone group and 8% (3/36) in the placebo group (p=0.3). Conclusion: Prednisone short-term administration not only does not prevent nevirapine rash, but also might increase its incidence.
Publication Types:
Keywords:
- Blindness
- CD4 Lymphocyte Count
- Clinical Protocols
- Didanosine
- Disease Progression
- Double-Blind Method
- Drug Therapy, Combination
- Exanthema
- HIV Infections
- Humans
- Incidence
- Male
- Nevirapine
- Placebos
- Prednisone
- Stavudine
- Viral Load
- drug therapy
- therapy
Other ID:
UI: 102247908
From Meeting Abstracts