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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tuberculosis Aids Hiv Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Nevirapine-based ART

Group Type EXPERIMENTAL

Nevirapine based therapy

Intervention Type DRUG

* Patients below 60 kg: 1 tablet twice a day of Triomune30®, including NVP 200 mg, 3TC 150 mg and D4T 30mg
* Patients above 60kg: 1 tablet twice a day of Triomune40®, including NVP 200 mg, 3TC 150 mg and D4T 40 mg)

Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)

Intervention Type DRUG

* Intensive phase: 2 months daily E(RMP)HZ. PTB smear positive patients at month 2 will receive 1 more month intensive phase.
* Continuation phase: 4 months daily H(RMP).
* Patients with meningitis will receive Streptomycin instead of E during intensive phase.

2

Efavirenz-based ART

Group Type ACTIVE_COMPARATOR

Efavirenz based therapy

Intervention Type DRUG

Efavirenz EFV 200 mg (3 tablets/d) Lamivudine 3TC 300mg (2 tablets of 150mg/d) D4T generic 30mg or 40mg (2 tablets/d)

Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)

Intervention Type DRUG

* Intensive phase: 2 months daily E(RMP)HZ. PTB smear positive patients at month 2 will receive 1 more month intensive phase.
* Continuation phase: 4 months daily H(RMP).
* Patients with meningitis will receive Streptomycin instead of E during intensive phase.

Interventions

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Nevirapine based therapy

* Patients below 60 kg: 1 tablet twice a day of Triomune30®, including NVP 200 mg, 3TC 150 mg and D4T 30mg
* Patients above 60kg: 1 tablet twice a day of Triomune40®, including NVP 200 mg, 3TC 150 mg and D4T 40 mg)

Intervention Type 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)

Intervention Type DRUG

Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)

* Intensive phase: 2 months daily E(RMP)HZ. PTB smear positive patients at month 2 will receive 1 more month intensive phase.
* Continuation phase: 4 months daily H(RMP).
* Patients with meningitis will receive Streptomycin instead of E during intensive phase.

Intervention Type DRUG

Other Intervention Names

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Triomune Stockrin Cipla drugs

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No