Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3

Launched by ANRS, EMERGING INFECTIOUS DISEASES · Feb 6, 2014

Keywords

ClinConnect Summary

Settings: Cambodia, Côte d'Ivoire, Uganda, Vietnam. Design: Multicentre, two-arm, unblinded randomized controlled superiority trial.

Objective: To compare the 24-week risk of death and occurrence of invasive bacterial infection between two experimental strategies in HIV-1 infected adults who start ART with a CD4 count \<100/mm3: (i) continuous extensive TB screening during follow-up each time the patient present with symptoms, versus (ii) systematic empirical TB treatment started 2 weeks before ART initiation.

Trial strategies:

At inclusion, participants will be randomized 1:1 in two str...

Gender

ALL

Eligibility criteria

• 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.