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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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12 December 2020 |
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Main ID: |
NCT02057796 |
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Date of registration:
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05/02/2014 |
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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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Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3
STATIS |
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Scientific title:
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Systematic Empirical vs. Test-guided Anti-tuberculosis Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating Antiretroviral Therapy With CD4 Cell Counts <100/mm3: the STATIS Randomized Controlled Trial |
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Date of first enrolment:
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September 2014 |
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Target sample size:
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1050 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02057796 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Cambodia
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Côte D'Ivoire
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Uganda
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Vietnam
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Contacts
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Name:
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François-Xavier Blanc, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Université de Nantes, Institut du thorax, CHU Nantes, France |
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Name:
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Kouao Médard Serge Domoua, 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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Service de Pneumologie, CHU de Treichville, Abidjan, Côte d'Ivoire |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age =18 years;
- HIV-1 infection as documented at any time prior to trial entry, as per national
testing procedures;
- CD4 <100 cells/mm3;
- No history of antiretroviral drug use (except transient ART for PMTCT);
- Able to correctly understand the trial and to sign the informed consent.
Exclusion Criteria:
- HIV-2 co-infection;
- Contra-indication to efavirenz;
- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >5 times the upper
limit of normal;
- Creatinine clearance <50 ml/min;
- Overt evidence that TB treatment should be started immediately;
- History of TB treatment in the past 5 years;
- Ongoing TB chemoprophylaxis (isoniazid preventive therapy);
- Any condition that would lead to differ ART initiation (e.g. acute condition requiring
investigations and/or treatment prior to ART initiation);
- Current pregnancy or breastfeeding.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV-1 Infection
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Intervention(s)
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Drug: ART (Atripla, Truvada, Efavirenz, Combivir)
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Drug: Rifampin, isoniazid, pyrazinamide, ethambutol
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Device: Xpert MTB/RIF®, Determine TB LAM, Chest X-ray
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Primary Outcome(s)
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All-cause mortality and incidence of invasive bacterial infections
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Incidence of grade 3 or 4 adverse events
[Time Frame: 24 Weeks and 48 weeks]
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Incidence of confirmed/probable/possible TB
[Time Frame: 24 Weeks and 48 weeks]
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Secondary ID(s)
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ANRS 12290
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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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