The safety and efficacy of switching stavudine to tenofovir df in combination with lamivudine and efavirenz in hiv-1-infected patients: three-year follow-up after switching therapy.

BACKGROUND: Study 903 is a phase 3 trial with a completed 144-week, double-blind phase comparing tenofovir DF (TDF) with stavudine (d4T), in combination with lamivudine (3TC) and efavirenz (EFV), and an ongoing 336-week open-label extension phase. METHOD: Patients in 3 countries completing the d4T treatment phase were allowed to switch d4T to TDF and receive once-daily TDF+3TC+EFV in the extension phase. RESULTS: At the time of switch, 100% and 99% of patients (n = 85; 60% male, 64% White; mean age 37 years; mean CD4 = 650 cells/mm3) had HIV RNA <400 and <50 copies/mL. At 144 weeks after the switch, 89% (missing = failure) had HIV RNA <400 copies/mL and 87% had HIV RNA <50 copies/mL. Mean CD4 cell count increased 155 cells/mm3. No patient had virologic failure. Significant decreases from switch to week 144 in mean fasting total cholesterol (-22 mg/dL, p < .0001) and triglycerides (-78 mg/dL, p < .0001) were observed. Mean limb fat increased significantly from 4.5 kg to 5.8 kg, 144 weeks after switch (p < .0001). CONCLUSION: In virologically suppressed patients, switching d4T to TDF as part of a once-daily regimen with 3TC and EFV resulted in maintenance of virologic suppression and continued CD4 cell increases through 144 weeks, with significant improvements in metabolic parameters.

The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral-naïve HIV-1-infected patients.

BACKGROUND: Study 903 is a phase 3 trial with a completed 144-week, double-blind phase comparing tenofovir DF (TDF) to stavudine (d4T) in combination with lamivudine (3TC) and efavirenz (EFV) and an ongoing additional 336-week open-label extension phase. METHOD: Patients in Brazil, Argentina, and the Dominican Republic who completed the 144-week double-blind phase on TDF were eligible to roll over to the extension phase (weeks 144-480). Results from an interim week 288 analysis are presented. RESULTS: Eighty-six patients (62% male, 70% white) initially randomized to the TDF arm continued treatment with TDF. At the end of the 144-week, double-blind phase, 85 of the 86 had HIV-1 RNA <400 copies/mL, of whom 84% maintained virologic suppression through week 288. CD4 counts continued to improve with a mean increase of 135 cells/mm(3) from entry into the open-label extension to week 288. No patient discontinued due to renal adverse events. Small changes in bone mineral density at the lumbar spine and hip were seen in the first 48 weeks but were nonprogressive through 288 weeks. Mean limb fat increased from 8.0 kg at week 96 to 8.8 kg at week 288. CONCLUSION: Through 288 weeks, once-daily TDF+3TC+EFV demonstrated sustained antiretroviral activity with continued immunologic recovery. TDF treatment was not associated with renal adverse events or limb fat loss in antiretroviral-naïve patients.

Estudo de fase II de acetato de megestrol em anorexia e perda de peso em pacientes com AIDS / Phase II trial of megestrol acetate in patients with Aids-related anorexia and weight loss

Objetivos: Avaliar o efeito da suspensäo oral de acetato de megestrol na alteraçäo de peso corpóreo, na diminuiçäo da anorexia e na melhora da qualidade de vida de pacientes com AIDS. Desenho do Estudo: Estudo aberto, com 600 mg de acetato de megestrol em suspensäo oral, por dia, por 12 semanas. Pacientes: Foram envolvidos no estudo 20 pacientes soropositivos para HIV, estando na faixa de 30 porcento de seu peso ideal e que perderam mais de 10 por cento de seu peso corpóreo inicial desde o diagnóstico da infecçäo por HIV. Resultados: Foram avaliados 20 pacientes soropositivos para HIV, sendo 8 (40 por cento) do sexo feminino, 12 (60 por cento) do sexo masculino, com idade média de 33,7 anos, recebendo 600mg/dia de acetato de megestrol. Antes do uso da medicaçäo do estudo, os pacientes apresentavam peso médio de 55,3 Kg e após o uso da mesma este valor passou a 62,8 Kg com ganho percentual de 13,6 porcento. Conclusöes: A ingestäo do medicamento acetato de megestrol teve grande importância na melhora do estado nutricional dos pacientes, uma vez que a maioria apresentou aumento de apetite e conseqüente aumento de peso sem apresentar intercorrências que pudessem interferir no diagnóstico do seu estado nutricional.