RESUMO
This is an open-label, single-arm, phase 3b study (part of phase 3 development) to evaluate the efficacy and safety of Fortovase-soft gelatin formulation (saquinavir-SGC), combined with zidovudine (ZDV) and lamivudine (3TC), human immune deficiency virus type 1 in (HIV-1)-positive, antiretroviral-naive individuals. Forty-two HIV-1-positive adults with plasma HIV RNA >10,000 copies per milliliter (Roche Amplicor HIV Monitor assay) and CD4 cell count >100 cells/mm(3) were treated with SQV-SGC, 1200 mg three times per day; ZDV, 300 mg; and 3TC, 150 mg each twice per day for 48 weeks. High proportions were drug users (26%), demonstrated psychiatric disorders (alcohol abuse [14%]/depression [14%]), or were inadequately housed (5%). At 48 weeks, 50% of patients achieved viral suppression <400 copies per milliliter with 43% <20 copies per milliliter using an intent-to-treat analysis (missing values counted as virological failures). Corresponding proportions for patients remaining on therapy at 48 weeks were 91% <400 copies per milliliter and 78% <20 copies per milliliter. Most adverse events were mild. Saquinavir-SGC combined with ZDV and 3TC, achieved potent and durable HIV RNA suppression and was well tolerated over 48 weeks in an antiretroviral-naive population including high proportions of individuals considered difficult to treat, such as drug users, people with psychiatric problems and homeless individuals.
Assuntos
Terapia Antirretroviral de Alta Atividade/métodos , Terapia Antirretroviral de Alta Atividade/psicologia , Infecções por HIV/tratamento farmacológico , Infecções por HIV/psicologia , Inibidores da Protease de HIV/uso terapêutico , Lamivudina/uso terapêutico , Transtornos Mentais/psicologia , Cooperação do Paciente/psicologia , Inibidores da Transcriptase Reversa/uso terapêutico , Saquinavir/uso terapêutico , Abuso de Substâncias por Via Intravenosa/psicologia , Migrantes/psicologia , Zidovudina/uso terapêutico , Adulto , Contagem de Linfócito CD4 , Cápsulas , Química Farmacêutica , Feminino , Infecções por HIV/etiologia , Infecções por HIV/imunologia , Infecções por HIV/virologia , Inibidores da Protease de HIV/química , HIV-1 , Humanos , Masculino , Transtornos Mentais/complicações , Cooperação do Paciente/estatística & dados numéricos , Projetos Piloto , Modelos de Riscos Proporcionais , Saquinavir/química , Abuso de Substâncias por Via Intravenosa/complicações , Migrantes/estatística & dados numéricos , Resultado do Tratamento , Carga ViralRESUMO
Treatment with high dose vitamin A has recently been recommended for children with measles in communities where vitamin A deficiency is a recognized problem. However, the relationship between vitamin A and measles mortality has not been clearly established. We studied serum vitamin A levels in 283 children less than or equal to 5 years of age admitted to Mama Yemo and Kalembe Lembe Hospitals in Kinshasa, Zaire, between January and March, 1987. Vitamin A levels were determined by high performance liquid chromatography. Vitamin A levels ranged from less than 5 to 63 micrograms/dl (median, 8). The overall case-fatality rate was 26 per cent. On univariate analysis, age less than 24 months, pneumonia on admission, lymphopenia (less than 2000/mm3), and lower vitamin A levels were associated with death during hospitalization. In a multivariate logistic regression model, a vitamin A level less than 5 micrograms/dl was associated with fatal outcome for children younger than 24 months old (relative risk = 2.9, 95 per cent CI 1.3, 6.8), but not for older children. Further studies are needed to determine whether low vitamin A levels predispose children to severe measles and the role of vitamin A supplements in the prevention of measles mortality.
Assuntos
Sarampo/mortalidade , Vitamina A/sangue , Pré-Escolar , República Democrática do Congo , Feminino , Humanos , Lactente , Masculino , Sarampo/tratamento farmacológico , Vitamina A/uso terapêuticoAssuntos
Síndrome da Imunodeficiência Adquirida/complicações , Sarampo/complicações , Síndrome da Imunodeficiência Adquirida/mortalidade , Criança , Pré-Escolar , República Democrática do Congo , Feminino , Soropositividade para HIV , Humanos , Masculino , Sarampo/mortalidade , Sarampo/prevenção & controle , Vacina contra Sarampo , Distribuição AleatóriaRESUMO
Unscreened blood transfusions continue to be one of the major modes of transmission of the human immunodeficiency virus (HIV) in developing countries, such as in Central Africa, where 5% to 18% of blood donors are HIV seropositive. We evaluated a rapid latex agglutination assay using a novel recombinant envelope polypeptide of HIV for the detection of HIV antibodies among 2820 blood donors and clinical patients from diverse geographic regions, including on-site testing in Central Africa of 1600 blood donors. Overall, 29.2% of the serum samples were positive by Western blot assay. On a single determination, the latex agglutination slide test was found to be highly sensitive and specific compared with Western blot results in these populations with a relatively high prevalence of infection. Use of this assay will allow the immediate implementation of serologic screening for HIV in developing areas of the world, where standard screening procedures are impractical or not available, and in many other clinical settings, such as sexually transmitted diseases clinics and hospitals, where testing and counseling could be promptly implemented.