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1.
HIV Clin Trials ; 14(3): 81-91, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23835510

RESUMO

OBJECTIVES: Week 96 efficacy and safety of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (RPV) was compared to efavirenz (EFV) in subset of 1,096 subjects who received emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in pooled data from 2 phase 3 studies. METHODS: ECHO and THRIVE are double-blind, double-dummy, randomized, active-controlled, non-inferiority phase 3 studies of RPV versus EFV plus 2 NRTIs in antiretroviral-naïve adult subjects. The primary and secondary endpoints were the proportion of subjects with HIV-1 RNA <50 copies/ mL using an intent-to-treat, time to loss of virologic response (ITT-TLOVR) analysis at weeks 48 and 96, respectively. Safety, tolerability, immunologic response, adherence level, and other measures were also evaluated. RESULTS: At week 48, noninferior efficacy of RPV+FTC/TDF over EFV+FTC/TDF was established, and at week 96 RPV+FTC/TDF remained noninferior (77% overall response rate in both groups). Through week 96, rates of virologic failure were higher in the RPV+FTC/ TDF group, with low and similar rates of virologic failure and resistance mutations occurring during the second year of follow-up. Treatment with RPV+FTC/TDF was associated with a lower rate of discontinuation due to adverse events and grade 2-4 adverse events including dizziness, abnormal dreams/nightmares, rash, and lipid abnormalities. CONCLUSIONS: The pooled ECHO and THRIVE studies demonstrated noninferiority of RPV+FTC/TDF in achieving virologic response with safety and tolerability advantages over EFV+FTC/TDF through 96 weeks. Higher rates of virologic failure in the RPV+FTC/TDF group were balanced with higher rates of discontinuations due to adverse events in the EFV+FTC/TDF group.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , HIV-1 , Adenina/administração & dosagem , Adenina/análogos & derivados , Adolescente , Adulto , Idoso , Alcinos , Fármacos Anti-HIV/administração & dosagem , Benzoxazinas/administração & dosagem , Ciclopropanos , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Método Duplo-Cego , Esquema de Medicação , Quimioterapia Combinada , Emtricitabina , Feminino , Infecções por HIV/virologia , Transcriptase Reversa do HIV/antagonistas & inibidores , Humanos , Masculino , Pessoa de Meia-Idade , Nitrilas/administração & dosagem , Organofosfonatos/administração & dosagem , Pirimidinas/administração & dosagem , Inibidores da Transcriptase Reversa/administração & dosagem , Rilpivirina , Tenofovir , Adulto Jovem
2.
Artigo em Inglês | MEDLINE | ID: mdl-9593462

RESUMO

Severe weight loss in HIV is associated with decreased length of survival. It is unclear whether mild weight loss is associated with an increased risk of death or opportunistic complications of HIV. Participants in four interventional studies (n = 2382) conducted by a community-based clinical trials network were evaluated for percentage change in weight during their first 4 months in the study. Proportional hazards models were performed for the occurrence of opportunistic complications and death subsequent to the 4-month visit. The relative risk of death and opportunistic complications for those with 5% to 10% weight loss over 4 months was 2.22 (p < .001) and 1.89 (p < .001), respectively, and 1.26 (p < .01) and 1.19 (p < .01) among those who lost 0% to 5% of their body weight, respectively, when compared with those with no weight loss. Among those who lost 5% to 10% of their body weight, the relative risk of individual opportunistic complications increased significantly, including Pneumocystis carinii pneumonia (PCP) (1.61; p < .01), cytomegalovirus (CMV) (2.33; p < .001), and Mycobacterium avium complex (MAC) (1.81; p < .01). As little as 5%t weight loss over a 4-month period is associated with increased risk of death and opportunistic complications in HIV. A weight loss of 5% to 10% is also associated with an increased risk of individual opportunistic complications.


Assuntos
Infecções Oportunistas Relacionadas com a AIDS/epidemiologia , Infecções por HIV/fisiopatologia , Redução de Peso , Adulto , Estudos de Coortes , Progressão da Doença , Feminino , Seguimentos , Infecções por HIV/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Análise de Sobrevida
3.
Prim Care ; 24(4): 905-19, 1997 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-9386262

RESUMO

The social role of alternative medicine is critical in empowering the large proportion of HIV-positive patients who choose to use nontraditionally prescribed medicines. Working toward an open scientific dialogue with HIV-related complementary therapies is a worthy goal for all providers.


Assuntos
Terapias Complementares , Infecções por HIV/terapia , Equipe de Assistência ao Paciente , Humanos , Atenção Primária à Saúde , Papel do Doente , Resultado do Tratamento
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