RIFART - RIFART

Conditions: HIV- TB
MedDRA version: 6.1Level: PTClassification code 10000565

Registration Number: EUCTR2007-007935-14-IT

Lead Sponsor: AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

We will enrol consecutive patients presenting at the clinical centres constituting the network, with a diagnosis of tuberculosis (presumptive or conclusive diagnosis) and HIV infection, with CD4 cell counts Saranno arruolati consecutivamente soggetti osservati presso i centri clinici partecipanti allo studio con diagnosi di tubercolosi (confermata o presuntiva) e co-infezione da HIV, and peripheral CD4 cell counts < 350 / cmm (if naive for antiretroviral therapy) of < 500 / cmm (if being already treated with antiretroviral drugs), who are able to provide written informed consent.
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Payients will not be eligible for the study if presentino with medical conditions (including allergy or poor tolerance to the study drugs, or infections which are resistano to any of the study drugs) contraindicating the use of one or more of the study drugs.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To campare the adherence rate in two regimens for the treatment of coinfection between tuberculosis and HIV;Secondary Objective: To comparare virological and immunological efficacy on HIV of the two regimens. To comparare tuberculosis treatment outcome of the two regimens. To compare the rate of adverse events and immune reconstitution syndrom in the two regimens. To describe the pharmacokinetic profile of ryfamicins when administered toghether with antiretroviral drugs (either efavirenz or lopinavir/ritonavir);Primary end point(s):

Secondary Outcome Measures