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HIV InfectionsPhase 3NCT00115609

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

A Phase 3 study testing efavirenz, tenofovir DF and emtricitabine in people with HIV Infections and Tuberculosis, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Tuberculosis
What is being tested?
efavirenz, tenofovir DF and emtricitabine
Type of treatment
Pill or oral medicine
How many people
70 participants
Where
1 siteFrance
Study dates
Jan 2006to Nov 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service des maladies Infectieuses et tropicales Hopital Necker-Enfants Malades

    Paris, 75015

Other trials in France

About this study

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

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.

Read the 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.

Being tested
efavirenz, tenofovir DF, emtricitabine
Keywords
HIV infections, tuberculosis, tuberculosis agents, Anti HIV agents, Treatment Naive
Medical subject headings
HIV Infections, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • efavirenzDrug

    Also called Sustiva

    800mg for patients treated by rifampicine 600mg for other patients

  • tenofovir DFDrug

    Also called Viread

    300mg once a day

  • emtricitabineDrug

    Also called Emtriva/FTC

    one pill of 200mg once a day

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment success rate at week 48 (W48)

    Measured: W48

Secondary outcomes (10)

  1. course of plasma HIV-1 RNA between W0 and W48

    Measured: W48

  2. tuberculosis cure rate

    Measured: W48

  3. safety of trial treatments (number of events, description, time to onset, metabolic disorders, immune restoration syndrome)

    Measured: W48

  4. frequency of treatment changes or discontinuations

    Measured: W48

  5. clinical progression of HIV infection

    Measured: W48

  6. course of CD4 and CD8 T lymphocytes

    Measured: W48

  7. study of resistance in the case of virological failure

    Measured: W48

  8. study of compliance and quality of life

    Measured: W48

  9. pharmacokinetic study of tuberculostatic agents

    Measured: W02,W08,W12, W24

  10. effect of treatment on hepatitis B viral replication

    Measured: W48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionNov 2009
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00115609
Sponsor's protocol ID
ANRS129 BKVIR
Other IDs
2005-002470-30, 2005
Status last verified
Apr 2026
First submitted
23 Jun 2005
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Lortholary O, Roussillon C, Boucherie C, Padoin C, Chaix ML, Breton G, Rami A, Veziris N, Patey O, Caumes E, May T, Molina JM, Robert J, Tod M, Fagard C, Chene G; ANRS 129 BKVIR Trial Group. Tenofovir DF/emtricitabine and efavirenz combination therapy for HIV infection in patients treated for tuberculosis: the ANRS 129 BKVIR trial. J Antimicrob Chemother. 2016 Mar;71(3):783-93. doi: 10.1093/jac/dkv384. Epub 2015 Dec 17.

    PubMed 26679250

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing efavirenz, tenofovir DF and emtricitabine in people with HIV Infections and Tuberculosis, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment success rate at week 48 (W48) (time frame: W48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00115609, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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