Rifabutin with lopinavir/ritonavir in patients coinfected with tuberculosis and HIV in Burkina Faso

Not Applicable

Recruiting

• Conditions: HIV/AIDS; Tuberculosis

• Registration Number: PACTR201310000629390
• Lead Sponsor: Institut de Recherche en Santé (IRSS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-24
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

HIV-1 infected patient
-Patient aged ¿18 years(minimum) and ¿ 60 years (maximum)
-Eligible for antiretroviral therapy including Lopinavir/ritonavir regimen (national guideline)
-Any CD4+
-New pulmonary tuberculosis (TPM), confirmed or suspected
-Eligible for antimycobacterial therapy including rifabutin
-Signed informed consent form
-For female patients : pregnancy test negative, non lactating, not planning to become pregnant during the follow-up period of the study.

Exclusion Criteria

-Patient doubly infected HIV 1 and 2 or HIV2
-ALAT > 5 NV
-creatinine> 3 NV
-Co-administration of treatment with an absolute contre indication (list to be established)Pregnancy or breastfeeding
-Presence of medical conditions or other conditions (allergy, intolerance) that contraindicate the administration of a drug in the studioChoice of the clinician to take antiretroviral therapy other than as provided under the Protocol
-People with MDR or XDR tuberculosis strain from
-Any medical condition that in the opinion of the investigator poses a risk to the patient

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the curve of rifabutin and the area under curve of Lopinavir/ritonavir : -Measured after 15 days of combined treatment rifabutin - lopinavir/ritonavir

Secondary Outcome Measures

Name	Time	Method
The number of subjects with adverse events to the development of combination treatment (both rifabutin that Lopinavir /r) during treatment with rifabutin 150 mg or 300 mg. ;The number of subjects with adverse events to the development of combination treatment (both rifabutin that Lopinavir /r) during treatment with rifabutin 150 mg or 300 mg.