HIV clinical trials · 2008
Seven-year efficacy of a lopinavir/ritonavir-based regimen in antiretroviral-naïve HIV-1-infected patients.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Murphy Robert L, da Silva Barbara A, Hicks Charles B, Eron Joseph J, Gulick Roy M, Thompson Melanie A, McMillan Florence, King Martin S, Hanna George J, Brun Scott C
Аннотация
OBJECTIVE: Evaluate efficacy and tolerability of lopinavir/ritonavir (LPV/r) plus stavudine and lamivudine long term in antiretroviral-naïve patients.
DESIGN: Open-label follow-up of prospective, randomized, multicenter trial.
METHOD: Antiretroviral-naïve HIV-infected subjects (N = 00) received of 3 doses of LPV/r plus stavudine and lamivudine for 48 weeks then received LPV/r soft-gel capsules 400/00 mg plus stavudine and lamivudine. After 6 years, subjects replaced stavudine with tenofovir.
RESULTS: At 7 years, by intent-to-treat analysis, 61 % had plasma HIV-RNA <400 copies/mL and 59% had < 50 copies/mL. Thirty-nine subjects discontinued treatment due to adverse events (n = 6), personal/other reasons (0), loss to follow-up (9), and noncompliance (4). Among 28 subjects qualifying for drug resistance testing, no protease inhibitor or stavudine resistance was observed and 4 showed lamivudine resistance. Most common drug-related moderate or severe adverse events were diarrhea (28%), nausea (6%), and abdominal pain (11 %). Subjects who received stavudine (median 6.6 years) and switched to tenofovir demonstrated significant improvements in total cholesterol (p = .009), triglycerides (p = .023), apolipoprotein C-III (p < .001 ), adiponectin (p = .008), fasting insulin (p = .04), and leptin (p = .03).
CONCLUSION: LPV/r-based therapy demonstrated sustained efficacy with no protease inhibitor or stavudine resistance through 7 years in antiretroviral-naïve patients. Switching from stavudine to tenofovir resulted in significant improvements in multiple metabolic parameters.
DESIGN: Open-label follow-up of prospective, randomized, multicenter trial.
METHOD: Antiretroviral-naïve HIV-infected subjects (N = 00) received of 3 doses of LPV/r plus stavudine and lamivudine for 48 weeks then received LPV/r soft-gel capsules 400/00 mg plus stavudine and lamivudine. After 6 years, subjects replaced stavudine with tenofovir.
RESULTS: At 7 years, by intent-to-treat analysis, 61 % had plasma HIV-RNA <400 copies/mL and 59% had < 50 copies/mL. Thirty-nine subjects discontinued treatment due to adverse events (n = 6), personal/other reasons (0), loss to follow-up (9), and noncompliance (4). Among 28 subjects qualifying for drug resistance testing, no protease inhibitor or stavudine resistance was observed and 4 showed lamivudine resistance. Most common drug-related moderate or severe adverse events were diarrhea (28%), nausea (6%), and abdominal pain (11 %). Subjects who received stavudine (median 6.6 years) and switched to tenofovir demonstrated significant improvements in total cholesterol (p = .009), triglycerides (p = .023), apolipoprotein C-III (p < .001 ), adiponectin (p = .008), fasting insulin (p = .04), and leptin (p = .03).
CONCLUSION: LPV/r-based therapy demonstrated sustained efficacy with no protease inhibitor or stavudine resistance through 7 years in antiretroviral-naïve patients. Switching from stavudine to tenofovir resulted in significant improvements in multiple metabolic parameters.