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Sponsors and Collaborators: |
French National Agency for Research on AIDS and Viral Hepatitis Medecins Sans Frontieres |
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Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00495326 |
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.
Condition | Intervention | Phase |
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Tuberculosis AIDS HIV Infections |
Drug: Nevirapine based therapy Drug: Efavirenz based therapy Drug: Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official 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) |
Estimated Enrollment: | 570 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Nevirapine-based ART
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Drug: Nevirapine based therapy
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2: Active Comparator
Efavirenz-based ART
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Drug: Efavirenz based therapy
Efavirenz EFV 200 mg (3 tablets/d) Lamivudine 3TC 300mg (2 tablets of 150mg/d) D4T generic 30mg or 40mg (2 tablets/d)
Drug: Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)
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Anti Retroviral Therapy (ART) reduces tuberculosis (TB) incidence in HIV-infected patients and reduces mortality among TB patients with deep immune suppression. The Fixed Drug Combination (FDC) nevirapine (NVP)-lamivudine-stavudine is the first line ART available for low-income countries. Rifampicin (RMP), due to its liver induction effect, reduces significantly NVP plasma concentration, raising concerns regarding the risk of resistance and subsequent treatment failure. Therefore, in co-infected patients, WHO recommends delaying ART or using efavirenz (EFV)-based ART. Although EFV is also reduced at lower level, longitudinal studies report good efficacy and safety when given concomitantly with RMP.
In low-income countries, poor access to EFV, contradiction during pregnancy and absence of FDC containing EFV lead to difficulties in HIV-TB treatment. Despite 2 limited retrospective studies and a non-randomised prospective study, which report good virological response at 6 months in co-infected patients receiving NVP and RMP co-administration, existing data are too limited to change the recommendation.
The aim of the study is to compare, in terms of therapeutic efficacy and clinical safety, the nevirapine-based HAART to the standard efavirenz-based HAART, in HIV/TB co-infected patients receiving a rifampicin-based TB treatment.
The study will evaluate one year after TB treatment initiation, whether the HAART efficacy (virological outcome, death or lost of follow-up) induced by NVP-based HAART is non-inferior to those induced by EFV based HAART, in patients receiving concomitantly HAART and RMP-based TB treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Amendment :
Contact: Maryline Bonnet, MD | +41 22 849 44 61 | Maryline.BONNET@geneva.msf.org |
Mozambique | |
Health centre of Alto Mae, Chamanculo district | Recruiting |
Maputo, Mozambique | |
Health centre of Josue Macao | Recruiting |
Maputo, Mozambique | |
Health centre of Malavane | Recruiting |
Maputo, Mozambique |
Principal Investigator: | Maryline Bonnet, MD | Epicentre |
Principal Investigator: | Nilesh Bhatt, MD | Ministry of Health, Instituto Nacional de Saude, Mozambique |
Responsible Party: | ANRS ( Severine Blesson ) |
Study ID Numbers: | ANRS 12146 CARINEMO |
Study First Received: | July 2, 2007 |
Last Updated: | April 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00495326 History of Changes |
Health Authority: | Mozambique: Ministry of Health (MISAU) |
drug interactions Treatment Naive |
Bacterial Infections Sexually Transmitted Diseases, Viral Stavudine Lamivudine Streptomycin Reverse Transcriptase Inhibitors Rifampin Anti-Bacterial Agents Gram-Positive Bacterial Infections Anti-Retroviral Agents Tuberculosis Retroviridae Infections Isoniazid |
Efavirenz Anti-HIV Agents Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Virus Diseases Nevirapine HIV Infections Sexually Transmitted Diseases Mycobacterium Infections Ethambutol Antitubercular Agents |
Bacterial Infections Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Rifampin Anti-Bacterial Agents Gram-Positive Bacterial Infections Anti-Retroviral Agents Therapeutic Uses Tuberculosis Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
Efavirenz RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Actinomycetales Infections Pharmacologic Actions Antibiotics, Antitubercular Virus Diseases Nevirapine HIV Infections Sexually Transmitted Diseases |