NCT00115609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Jan 2006

Typical duration for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2005

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

June 23, 2005

Last Update Submit

April 3, 2026

Conditions

HIV InfectionsTuberculosis

Keywords

HIV infectionstuberculosistuberculosis agentsAnti HIV agentsTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • treatment success rate at week 48 (W48)

    W48

Secondary Outcomes (10)

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

    W48

  • tuberculosis cure rate

    W48

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

    W48

  • frequency of treatment changes or discontinuations

    W48

  • clinical progression of HIV infection

    W48

  • +5 more secondary outcomes

Interventions

efavirenzDRUG

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

Also known as: Sustiva
tenofovir DFDRUG

300mg once a day

Also known as: Viread
emtricitabineDRUG

one pill of 200mg once a day

Also known as: Emtriva/FTC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service des maladies Infectieuses et tropicales Hopital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

  • 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.

    PMID: 26679250RESULT

Related Links

MeSH Terms

Conditions

HIV InfectionsTuberculosis

Interventions

efavirenzTenofovirEmtricitabine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Olivier Lortholary, MD

    Hopital Necker-Enfants malades

    PRINCIPAL INVESTIGATOR

  • Geneviève Chêne, MD

    INSERM U593

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2005

First Posted

June 24, 2005

Study Start

January 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

FR(1)