Hiv Infections Clinical Trial
— CARINEMOOfficial title:
Randomized Non-inferiority Trial Comparing the Nevirapine-based Antiretroviral Therapy Versus the Standard Efavirenz-based ART for the Treatment of HIV-TB Co-infected Patients on Rifampicin-based Therapy (ANRS 12146 CARINEMO)
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.
Status | Completed |
Enrollment | 570 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mozambique | Health centre of Alto Mae, Chamanculo district | Maputo | |
Mozambique | Health centre of Josue Macao | Maputo | |
Mozambique | Health centre of Malavane | Maputo |
Lead Sponsor | Collaborator |
---|---|
French National Agency for Research on AIDS and Viral Hepatitis | Medecins Sans Frontieres |
Mozambique,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Viral load measure (Virological failure will be defined after 2 consecutive measures as : More than 1 log10 increase in plasma HIV-1 RNA concentration for patients with detectable viral load (> 50 copies/mL) at the previous dosage.) | 3, 6 and 12 months | No | |
Secondary | New or recurrent stage 3 or 4 HIV/AIDS related events | 12 months | No | |
Secondary | Deaths after one year | 12 months | Yes | |
Secondary | Severe drugs side effects | 12 months | Yes | |
Secondary | Immune Reconstitution Syndrome(IRIS) | 12 months | Yes | |
Secondary | Increase of CD4 cell count induced by HAART | at 6 months and 1 year | No | |
Secondary | Pharmacokinetic profile of nevirapine when combined with rifampicin | 2 months | Yes | |
Secondary | Rifampicin plasma concentration dosage | 2 months | No |
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