Preliminary efficacy and safety of oral suspension SH, combination of five chinese medicinal herbs, in people living with HIV/AIDS ; the phase I/II study.

OBJECTIVE: To evaluate the preliminary efficacy and safety of the mixture of drug extracts from 5 Chinese medicinal herbs (SH), in the treatment of Human Immunodeficiency Virus (HIV) infection among people living with HIV/AIDS (PLWHA). DESIGN: Open-label study. SETTING : Sanpatong Hospital, Chiang Mai, Thailand. SUBJECTS : HIV-1 infected adults with a CD4 cell count of more than 200 cell/mm3 and HIV-1 RNA > 20,000 copies/ml. MATERIAL AND METHOD: Patients received an oral suspension of SH, a combination of 5 Chinese medicinal herbs namely Glycyrrhiza glaba L., Artemisia capillaris Thumb., Morus alba L., Astragalus membranaceus(Fisch.) Bge., Carthamus tinctorius L., 5 g or 30 ml, in 3 divided doses after meals, plus sulfamethozaxole/ trimethoprim, 400/80 mg tablet, once daily after breakfast for 12 weeks. During the treatment and the follow up period, the absolute CD4 cell count and the plasma HIV-1 RNA were monitored. Adverse events were observed. RESULTS: Of the 28 enrolled patients, the number of positive response patients with reduction of plasma HIV-1 RNA more than 0.5 log during the treatment and follow up period were 4-10 (14.2-35.7%) while the number of negative response patients who had plasma HIV-1 RNA rising at least 0.5 log were 2-4 (0-14.2%). The means viral load at week 0 (baseline), 12 and 20 were 4.94, 4.83 and 4.76 log copies/ml, which were slightly declined Whilst, the mean absolute CD4 cell count of week 0 (baseline), 4, 8, 12, and 20 fluctuated within the baseline, range of 382.1, 404.2, 359.4, 404.1, 360.2 cell/mm3, respectively. All subjects had good compliance without any serious adverse events. CONCLUSION: Under the condition used, SH drug therapy is safe. Satisfactory positive response, by decreased viral load of more than 0.5 log, was found in 14%-35% of HIV-positive patients. However, the immunologic response, an increase of CD4 cell count was not clearly demonstrated. The clinical benefit of SH needs more thorough scientific support before being prescribed as adjunctive therapy for treating PLWHA.

Randomized, double-blind trial comparing indinavir alone, zidovudine alone and indinavir plus zidovudine in antiretroviral therapy-naive hiv-infected individuals with CD4 cell counts between 50 and 250/mm3

Treatment with indinavir has been shown to result in marked decreases in viral load and increases in CD4 cell counts in HIV-infected individuals. A randomized double-blind study to evaluate the efficacy of indinavir alone (800 mg q8h), zidovidine alone (200 mg q8h) or the combination was performed to evaluate progression to AIDS. 996 antiretroviral therapy-naive patients with CD4 cell counts of 50-250/mm3 were allocated to treatment. During the trial the protocol was amended to add lamivudine to the zidovudine-containing arms. The primary endpoint was time to development of an AIDS-defining illness or death. The study was terminated after a protocol-defined interim analysis demonstrated highly significant reductions in progression to a clinical event in the indinavir-containing arms, compared to the zidovudine arm (<0.0001). Over a median follow-up of 52 weeks (up to 99 weeks), percent reductions in hazards for the indinavir plus zidovudine and indinavir groups compared to the zidovudine group were 70 percent and 61 percent, respectively. Significant reductions in HIV RNA and increases in CD4 cell counts were also seen in the indinavir-containing groups compared to the zidovudine group. Improvement in both CD4 cell count and HIV RNA were associated with reduced risk of disease progression. All three regimens were generally well tolerated

Cloridrato de amantadina no tratamento de portadores de hepatite crônica C näo-respondedores ao alfa-interferon: efeito sobre os níveis séricos de ALT e carga viral / Amantidine-HCL in treatment of chronic hepatitis C in non-responders to alpha-interferom. Effect on ALT serum levels and viral load

Devido à limitada eficácia do alfa-interferon no tratamento da hepatite crônica C, o cloridrato de amantadina foi proposto como possível alternativa terapêutica. Entretanto, são poucos os estudos sobre a eficácia dessa droga na hepatite crônica C, sendo seus resultados controversos. Com a finalidade de avaliar os efeitos da amantadina sobre os níveis séricos de alanina aminotransferase e carga viral, 18 pacientes (14 homens e 4 mulheres) portadores crônicos de VHC não-respondedores a curso prévio de alfa-interferon foram selecionados para estudo prospectivo aberto, durante o qual receberam 100 mg da droga via oral de 12/12 horas, por quatro meses. Critérios de inclusão: presença de RNA no soro, níveis elevados de alanina aminotransferase, inflamação crônica hepática e consentimento informado escrito. De acordo com os achados de biopsia hepática pré-tratamento, o grupo constituiu-se de 14 portadores de hepatite crônica (hepatite crônica persistente n = 6, hepatite crônica ativa n = 8) e de 4 portadores de cirrose hepática. O genótipo do VHC mais freqüentemente encontrado em 17 pacientes testados foi o 3a (n = 9,52,94 por cento), seguido do 1b (n = 6, 32,29 por cento). A carga viral (amplicor HCV Monitor, Roche, EUA) e o nível de alanina aminotransferase foram avaliados pré e pós-tratamento. Dezessete pacientes completaram com boa tolerância. Em um caso, a droga foi suspensa por depressão severa. Comparando-se os valores médios basais de alanina aminotransferase e carga viral com os obtidos ao término do tratamento, não se observou redução estatisticamente significativa: alanina aminotransferase antes e depois, respectivamente 139,118 + 79,789 vs 99,588 + 62,583 U/l (P = 0,059) e carga viral pré e pós-tratamento, respectivamente 7,154 + 1,596 vs 6,574 + 1,584 log copias/ml (P = 0,147). O presente estudo não mostrou benefício pelo uso isolado da amantadina no tratamento de portadores de hepatite crônica C não-respondedores ao alfa-interferon. Os autores sugerem a necessidade de estudos com amantadina isolada em pacientes virgens de tratamento para a real definição de sua eficácia em relação à obtida pelo uso de interferon.

Reacción en cadena de la polimerasa "on-stage" y "nested": comparación de dos métodos para detectar el ARN del virus C en pacientes con hepatitis crónica C tratados con alfa interferón / One-stage and nested polymerase chain reaction: comparison of two methods to detect virus C RNA in patients with chronic hepatitis C treated with alfa interferon

El ARN del virus (HCV RNA) se detecta con la técnica de la reacción en cadena de la polimerasa (PCR), utilizándose dos variantes: la PCR "one-stage" y la PCR "nested". Comparamos ambas variantes en 40 muestras de suero de pacientes con hepatitis crónica C, 20 obtenidas antes del tratamiento con interferón alfa recombinante y 20 al concluir el mismo. El HCV RNA se detectó en 16 (80 ciento por ciento) de las muestras post-tratamiento, con iguales resultados positivos y negativos en ambas variantes. En 7 casos estudiamos las muestras pre y post-tratamiento de los mismos pacientes. Las muestras de los 7 pacientes fueron positivas por PCR "one-stage" y PCR "nested" al comenzar el tratamiento y de sólo 4 al concluirlo (1 con respuesta completa inmediata y 3 no respondedores). Tres pacientes se negativizaron con respuesta completa inmediata. Nuestro estudio muestra una correlación absoluta entre la PCR "one-stage" y la PCR "nested", sin que ésta se modifique por las posibles variaciones de la viremia provocadas por el interferón