HIV- TB MedDRA version: 6.1 Level: PT Classification code 10000565
Conditions
Interventions
Trade Name: RIFADIN
Pharmaceutical Form: Tablet
INN or Proposed INN: Rifampicin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Trade Name: MYCOBUTIN
Pharmace
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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): | — |
Countries
Italy
Outcome results
None listed