Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)

HIV Infections Clinical Trial

Official title:

Pilot Trial Evaluating Once Daily Triple Combination Antiretroviral Therapy With Tenofovir-Emtricitabine and Efavirenz in HIV-1 Infected Patients With Mycobacterium Tuberculosis Infection ANRS129 BKVIR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115609
• Other study ID #: 2005-002470-30
• Secondary ID: ANRS129 BKVIR
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2005
• Last updated: December 21, 2011
• Start date: January 2006
• Est. completion date: November 2009

Study information

• Verified date: December 2011
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Successful therapy of both tuberculosis and HIV disease share similar problems: pill burden, drug interaction, adherence challenge and toxicity. This study will test the efficacy and safety of a once daily antiretroviral regimen in HIV-tuberculosis coinfected patients.

Description:

The proposed research consists of conducting a pilot trial "BKVIR" designed to answer the question of whether once daily tenofovir-emtricitabine-efavirenz triple-agent therapy is effective and well tolerated when it must be initiated within three months after initiation of a three-agent or four-agent tuberculostatic therapy in antiretroviral-naive HIV-infected patients. As the proposed pilot trial comprises the initiation of antiretroviral therapy during the three months following the initiation of tuberculostatic therapy, we propose to set up systematic, continuous registration of HIV-infected patients with a diagnosis of tuberculosis in participating centers during the study period in order to evaluate their eligibility for inclusion in the pilot trial. The initial declaration phase in the register, in addition to facilitating inclusions in the pilot trial, should also allow: 1) a better understanding of the reasons for non-inclusion in the trial, allowing the eligibility criteria to be adjusted if necessary during the trial; and 2) to describe the antiretroviral therapies used during co-infection and their time of initiation in relation to tuberculostatic therapy.

This research is expected to contribute to an updating of the treatment guidelines in the context of tuberculosis in HIV-infected patients. The data collected will constitute a unique database on this issue not only in France, but also internationally, which will also be useful to optimize management strategies of these two diseases in developing countries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients = 18 years

• Infected by HIV-1

• Naive to antiretroviral therapy

• Presenting an indication to start antiretroviral therapy (according to the recommendations of the Delfraissy 2004 report)

• Histologically or microbiologically confirmed tuberculosis

• Receiving tuberculostatic therapy for less than three months

Exclusion Criteria:

• Isolated HIV-2 infection

• Neoplasm treated by chemotherapy and/or radiotherapy

• Pregnancy or plans for pregnancy

• Breastfeeding

• Contraindication to one of the antiretroviral drugs

• Atypical mycobacterial infection

• Hemoglobin below 8 g/dL

• Neutrophils below 750/mm3

• Platelets below 50,000/mm3

• Creatinine clearance below 60 ml/min

• Alkaline phosphatase, ASAT, ALAT or bilirubin over 3 times the upper limit of normal

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Infection
• Tuberculosis

Intervention

Drug:
• efavirenz
800mg for patients treated by rifampicine 600mg for other patients
• tenofovir DF
300mg once a day
• emtricitabine
one pill of 200mg once a day

Locations

Country	Name	City	State
France	Service des maladies Infectieuses et tropicales Hopital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment success rate at week 48 (W48)		W48	Yes
Secondary	course of plasma HIV-1 RNA between W0 and W48		W48	Yes
Secondary	tuberculosis cure rate		W48	Yes
Secondary	safety of trial treatments (number of events, description, time to onset, metabolic disorders, immune restoration syndrome)		W48	Yes
Secondary	frequency of treatment changes or discontinuations		W48	No
Secondary	clinical progression of HIV infection		W48	Yes
Secondary	course of CD4 and CD8 T lymphocytes		W48	No
Secondary	study of resistance in the case of virological failure		W48	Yes
Secondary	study of compliance and quality of life		W48	No
Secondary	pharmacokinetic study of tuberculostatic agents		W02,W08,W12, W24	Yes
Secondary	effect of treatment on hepatitis B viral replication		W48	Yes

External Links

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