Comparison of Nevirapine and Efavirenz for the Treatment of HIV-TB Co-infected Patients (ANRS 12146 CARINEMO)

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the use of Nevirapine in HIV patients already treated against tuberculosis by Rifampicin is as efficient and as well tolerated as Efavirenz.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Medecins Sans Frontieres, Netherlands
• Treatments: Efavirenz; Ethambutol; Isoniazid; Nevirapine; Rifampin

Criteria

Inclusion Criteria:

• Person HIV infected

• Aged of 18 years or more

• Signed informed consent

• New case of tuberculosis: patient who never received TB treatment or for less than 1 month

• Patients receiving rifampicin based TB regimen since 4 to 6 weeks

• CD4 cell count < 250 cell/mm3 in the 4 weeks following the TB diagnosis

• Naïve of HAART

• For women of childbearing age, to have a negative plasmatic test for pregnancy and to accept to take a contraception or declare no wish of pregnancy in the coming year.

Exclusion Criteria:

• To have a positive plasmatic test for pregnancy

• Karnofsky score <60%

• ALAT > 4N (Hepatitis grade 3 or 4)

• Ongoing psychiatric pathology

• Refuse to participate in the study

Amendment :

• bilirubin > grade 3

• any grade 4 clinical sign or biological result at time of inclusion