HIV infection MedDRA version: 9.1 Level: HLT Classification code 10052740 Term: Acquired immunodeficiency syndromes
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Efavirenz
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceutical Form: Tablet
INN or Proposed INN: Ef
Sponsors
AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 2.5 times upper to the normal value; - serum creatinin > 2 times upper to the normal value; - Karnofsky index < 50.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To describe and compare the kinetics of immune recovery degree and quality in advanced naive HIV-infected individuals (CD4+ 50-150 cells/&#61549;l) starting as first regimen an EFV-based HAART regimen compared to ?less advanced? patients (CD4+>250 cells/&#61549;l) 2. To thoroughly characterise the role and kinetics of specific immune parameters in immune reconstitution following EFV-based HAART;Secondary Objective: 1. To describe the kinetics of HIV-RNA decay in plasma of patients of the two groups 2. To describe the kinetics of intracellular HIV DNA in total peripheral blood CD4;Primary end point(s): The primary efficacy variables of the study are: - proportion of subjects who have a CD4+ T cell number increase > 20% after 24 weeks of EFV-based HAART; - changes from baseline of peripheral CD4+ and CD8+ T-cell activation and proliferation rates; - changes from baseline of peripheral CD4+ and CD8+ apoptosis rate; - changes from baseline of levels and function of interleukin-7 (IL-7) and interleukin-15 (IL-5), as T-cell homeostasis cytokine regulators; - frequency of circulating HIV-specific IFN-&#61543; and IL-2 producing T-cells; - frequency of circulating HIV-specific CD8+ IFN-&#61543; ELISPOT responses; - frequency of circulating T-regulatory CD4+ T cells (Treg); - changes from baseline of patterns of CD4 and CD8 T-cell maturation | — |
Countries
Italy
Outcome results
None listed