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

This study has been completed.
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis Identifier:
First received: June 23, 2005
Last updated: December 21, 2011
Last verified: December 2011
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.

Condition Intervention Phase
HIV Infections Tuberculosis Drug: efavirenz Drug: tenofovir DF Drug: emtricitabine Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:
  • treatment success rate at week 48 (W48) [ Time Frame: W48 ]

Secondary Outcome Measures:
  • course of plasma HIV-1 RNA between W0 and W48 [ Time Frame: W48 ]
  • tuberculosis cure rate [ Time Frame: W48 ]
  • safety of trial treatments (number of events, description, time to onset, metabolic disorders, immune restoration syndrome) [ Time Frame: W48 ]
  • frequency of treatment changes or discontinuations [ Time Frame: W48 ]
  • clinical progression of HIV infection [ Time Frame: W48 ]
  • course of CD4 and CD8 T lymphocytes [ Time Frame: W48 ]
  • study of resistance in the case of virological failure [ Time Frame: W48 ]
  • study of compliance and quality of life [ Time Frame: W48 ]
  • pharmacokinetic study of tuberculostatic agents [ Time Frame: W02,W08,W12, W24 ]
  • effect of treatment on hepatitis B viral replication [ Time Frame: W48 ]

Enrollment: 70
Study Start Date: January 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: efavirenz
    800mg for patients treated by rifampicine 600mg for other patients
    Other Name: Sustiva
    Drug: tenofovir DF
    300mg once a day
    Other Name: Viread
    Drug: emtricitabine
    one pill of 200mg once a day
    Other Name: Emtriva/FTC
Detailed 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00115609

Service des maladies Infectieuses et tropicales Hopital Necker-Enfants Malades
Paris, France, 75015
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Principal Investigator: Olivier Lortholary, MD Hopital Necker-Enfants malades
Study Director: Geneviève Chêne, MD INSERM U593
  More Information

Additional Information:
Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis Identifier: NCT00115609     History of Changes
Other Study ID Numbers: 2005-002470-30
Study First Received: June 23, 2005
Last Updated: December 21, 2011

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
HIV infections
tuberculosis agents
Anti HIV agents
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers processed this record on September 19, 2017