HIV Infections, Tuberculosis
Conditions
Keywords
HIV infections, tuberculosis, tuberculosis agents, Anti HIV agents, Treatment Naive
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.
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.
Interventions
DRUGefavirenz
800mg for patients treated by rifampicine 600mg for other patients
DRUGtenofovir DF
300mg once a day
DRUGemtricitabine
one pill of 200mg once a day
Sponsors
French National Agency for Research on AIDS and Viral Hepatitis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment success rate at week 48 (W48) | W48 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| course of plasma HIV-1 RNA between W0 and W48 | W48 |
| study of resistance in the case of virological failure | W48 |
| study of compliance and quality of life | W48 |
| pharmacokinetic study of tuberculostatic agents | W02,W08,W12, W24 |
| effect of treatment on hepatitis B viral replication | W48 |
| course of CD4 and CD8 T lymphocytes | W48 |
Countries
France
Outcome results
None listed