Immunological efficacy of efavirenz based treatment in HIV-positive naive patients (a pylot study) - IMMUNEF

AZIENDA OSPEDALIERA SAN GERARDO DI MONZA0 个研究点开始时间: 2008年11月12日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•- male or female subject 18 to 50 years of age inclusive; - the subject should be able to understand and comply with protocol requirements, instruction and protocol-stated restrictions; - signed and dated written informed consent form prior to admission to the study; - HIV positive status tested with ELISA and confirmed by Western Blot; - documented CD4+ T cell count between 50 and 150/l (advanced) - documented CD4+ T cell count > 250/l (less advanced); - genotypic test allows study drugs; - no prior or current use of antiretroviral therapy; - no current opportunistic infection (at least 2 weeks must have passed from the end of the therapy for OI); - no current use of systemic or inhaled steroids within the prior two months; - no current use of immune modulating agents, HIV immunotherapeutic agents or vaccines; - if female, be neither pregnant nor breastfeeding, and willing to use two methods of contraception (physical and hormonal double barrier method) throughout the duration of the study or be menopausal or of non-child bearing potential. All subjects should have been advised on practice of safe sex.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- in the investigator?s opinion subject who is unlikely to comply with the protocol and complete the study; - primary HIV-1 infection; - current opportunistic infection; - genotypic test not allowing the study drugs; - subject with current abuse of alcohol (>21 units/week or >3 units/day for males; >14 units/week or >2 units/day for females [1 unit is equivalent to half-pint (220 ml) of beer or 1 (25 ml) measure of spirits or 1 glass (125 ml) of wine] or illicit drug use; - current use of immune modulating agents or HIV immunotherapeutic vaccines; - current use of natural or herbal therapies; - current use of systemic or inhaled steroids and/or use of these therapies within the two months prior to enrolment; - pregnant or lactating female; - subject with any of the following laboratory results within 14 days prior to the first dose of the antiretroviral treatment: - haemoglobin concentration < 10 mg/dl for men and < 9.0 mg/dl for women; - neutrophil count < 1000 cells/mm3; - platelet count < 75,000 cells/mm3; - AST and ALT > 2.5 times upper to the normal value; - serum creatinin > 2 times upper to the normal value; - Karnofsky index < 50.

发起方

AZIENDA OSPEDALIERA SAN GERARDO DI MONZA