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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115609
Recruitment Status : Completed
First Posted : June 24, 2005
Last Update Posted : December 22, 2011
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Tuberculosis Drug: efavirenz Drug: tenofovir DF Drug: emtricitabine Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
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
Study Start Date : January 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

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

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: June 24, 2005    Key Record Dates
Last Update Posted: December 22, 2011
Last Verified: December 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