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

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

In countries with a high tuberculosis (TB) prevalence, TB and invasive bacterial infections are leading causes of early death in patients who initiate antiretroviral therapy (ART) with advanced immunodeficiency.

We hypothesize that a systematic 6-month empirical TB treatment initiated 2 weeks before the introduction of ART in HIV-infected adults with severe immunosuppression (CD4<100/mm3) and no overt evidence of TB will reduce the risk of death and invasive bacterial infections. This strategy will be compared to one of extensive TB testing using point-of-care tests (Xpert MTB/RIF® and urine lipoarabinomanan LAM) and chest X-ray to identify and treat only patients with at least one positive test suggestive of TB.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Treatments: Efavirenz; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Ethambutol; Isoniazid; Lamivudine, zidovudine drug combination; Pyrazinamide; Rifampin

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.