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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115609

Locations
France
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
Investigators
Principal Investigator: Olivier Lortholary, MD Hopital Necker-Enfants malades
Study Director: Geneviève Chêne, MD INSERM U593
  More Information

Additional Information:
No publications provided

Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT00115609     History of Changes
Other Study ID Numbers: 2005-002470-30, ANRS129 BKVIR
Study First Received: June 23, 2005
Last Updated: December 21, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Tenofovir
Tenofovir disoproxil
Efavirenz
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 25, 2014