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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00115609
First received: June 23, 2005
Last updated: December 21, 2011
Last verified: December 2011

June 23, 2005
December 21, 2011
January 2006
November 2009   (final data collection date for primary outcome measure)
treatment success rate at week 48 (W48) [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  • treatment success rate at week 48 (W48)
  • plasma HIV-1 RNA is less than 50 copies/mL at W48
  • tuberculosis is cured at W48
Complete list of historical versions of study NCT00115609 on ClinicalTrials.gov Archive Site
  • course of plasma HIV-1 RNA between W0 and W48 [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  • tuberculosis cure rate [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  • safety of trial treatments (number of events, description, time to onset, metabolic disorders, immune restoration syndrome) [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  • frequency of treatment changes or discontinuations [ Time Frame: W48 ] [ Designated as safety issue: No ]
  • clinical progression of HIV infection [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  • course of CD4 and CD8 T lymphocytes [ Time Frame: W48 ] [ Designated as safety issue: No ]
  • study of resistance in the case of virological failure [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  • study of compliance and quality of life [ Time Frame: W48 ] [ Designated as safety issue: No ]
  • pharmacokinetic study of tuberculostatic agents [ Time Frame: W02,W08,W12, W24 ] [ Designated as safety issue: Yes ]
  • effect of treatment on hepatitis B viral replication [ Time Frame: W48 ] [ Designated as safety issue: Yes ]
  • course of plasma HIV-1 RNA
  • tuberculosis cure rate
  • safety of trial treatments (number of events, description, time to onset, metabolic disorders, immune restoration syndrome)
  • frequency of treatment changes or discontinuations
  • clinical progression of HIV infection
  • course of CD4 T lymphocytes
  • study of resistance in the case of virological failure
  • study of compliance and quality of life
  • pharmacokinetic study of tuberculostatic agents
  • effect of treatment on hepatitis B viral replication
Not Provided
Not Provided
 
Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)
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

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Tuberculosis
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00115609
2005-002470-30, ANRS129 BKVIR
Yes
French National Agency for Research on AIDS and Viral Hepatitis
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: Olivier Lortholary, MD Hopital Necker-Enfants malades
Study Director: Geneviève Chêne, MD INSERM U593
French National Agency for Research on AIDS and Viral Hepatitis
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP