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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00115609 |
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Date of registration:
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23/06/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis (ANRS129)
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Scientific title:
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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 |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00115609 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Geneviève Chêne, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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INSERM U593 |
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Name:
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Olivier Lortholary, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hopital Necker-Enfants malades |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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HIV Infections
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Tuberculosis
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Intervention(s)
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Drug: efavirenz
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Drug: tenofovir DF
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Drug: emtricitabine
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Primary Outcome(s)
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treatment success rate at week 48 (W48)
[Time Frame: W48]
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Secondary Outcome(s)
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frequency of treatment changes or discontinuations
[Time Frame: W48]
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study of resistance in the case of virological failure
[Time Frame: W48]
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course of CD4 and CD8 T lymphocytes
[Time Frame: W48]
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safety of trial treatments (number of events, description, time to onset, metabolic disorders, immune restoration syndrome)
[Time Frame: W48]
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course of plasma HIV-1 RNA between W0 and W48
[Time Frame: W48]
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study of compliance and quality of life
[Time Frame: W48]
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effect of treatment on hepatitis B viral replication
[Time Frame: W48]
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pharmacokinetic study of tuberculostatic agents
[Time Frame: W02,W08,W12, W24]
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clinical progression of HIV infection
[Time Frame: W48]
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tuberculosis cure rate
[Time Frame: W48]
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Secondary ID(s)
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ANRS129 BKVIR
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2005-002470-30
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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