Interaction Between High Dose Rifampicine and Efavirenz in Pulmonary Tuberculosis and HIV Co-infection

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

We propose a first interaction study between efavirenz (EFV) and R20mg/Kg taking into consideration the absence of data about R induction at this dose. Due to an important inter-patient variability of the CYP2B6 polymorphism, the EFV pharmacokinetic (Pk) will be compared in same patients with and without TB treatment.

The main objective is to compare the Pk parameters of EFV in HIV-TB co-infected patients, with and without TB treatment, using R at 10 and 20mg/Kg/day and EFV at 600 and 800mg/day.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Efavirenz

Criteria

Inclusion Criteria:

• Aged of 18 years or more

• Diagnosis of new pulmonary tuberculosis confirmed by a XpertMTB/RIF test

• Positive HIV antibody test, naïve of ART with CD4 cell count between 50 and 250cells/mm3

• For women of childbearing age, to have a negative urine test for pregnancy on the day of enrolment and to accept to take a barrier contraception during the period of the trial

• Participants well enough to receive ambulatory treatment

• Weight > 45Kg

• Home address readily accessible

• Participants providing informed consent to participate in the trial

Exclusion Criteria:

• Rifampicin drug resistance based on the XpertMTB/RIF result confirmed by the GenotypeMTBDRplus assay

• Concomitant opportunistic infection requiring additional infectious medication

• Karnofsky score <80%

• ALAT or bilirubin > 5.0 x ULN (hepatitis grade 3 or 4)

• Haemoglobin < 7.5g/dL (grade 3 or 4)

• Grade 4 clinical sign or biological result according to the ANRS for grading the intensity of adverse events

• Patient not able to give his informed consent or is unlikely or unable to cooperate with sampling procedures

• Patient suffering of psychiatric illness, which may prevent follow-up according to the protocol

• Patients receiving or requiring medications that may interfere with study drugs