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

• Conditions: HIV infection; MedDRA version: 9.1Level: HLTClassification code 10052740Term: Acquired immunodeficiency syndromes

• Registration Number: EUCTR2008-006188-35-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SAN GERARDO DI MONZA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-12
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified