Health Trials

Tnf Inhibitors to Reduce Mortality in HIV-1 Infected PAtients With Tuberculosis meNIngitis

ConditionsTuberculous MeningitisHIV I Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorANRS, Emerging Infectious Diseases

About this trial

Randomized phase II clinical trial which aims to assess the impact on 3-month mortality and safety of adding adalimumab to standard treatment (anti-tuberculosis drugs and corticosteroids) in HIV patients with tuberculosis meningitis in 3 countries (Brazil, Mozambique, and Zambia).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

HIV-1 infection

Definite or probable tuberculosis meningitis

Standard tuberculosis meningitis treatment ≤3 days: anti TB drugs at standard doses and high-dose dexamethasone as per WHO guidelines

Disqualifiers

Other concomitant neurological infection, i.e. toxoplasmosis, cryptococcosis, progressive multifocal leukoencephalopathy, bacterial meningitis, neuro-syphilis

Asymptomatic positive cryptococcal antigen in serum

HBsAg positive or anti hepatitis C virus antibodies positive

Alanine transaminase (ALT)>5 ULN

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adalimumab Injection

    Drug

    one sub-cutaneous injection, every 2 weeks for 10 weeks (total 6 injections), started as soon as possible during the first 3 days of antituberculosis treatment and high-dose steroids

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Adalimumab armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

3-month all-cause mortality

Time frame
3 months

Secondary outcomes

1

3-month incidence of severe/life threatening bacterial infections and opportunistic infections

Time frame
3 months
2

3-month incidence of grade 3 and 4 adverse reactions and those leading to ART or anti tuberculosis treatment (ATT) interruption

Time frame
3 months
3

3-month incidence of all grade 3 and 4 adverse events

Time frame
3 months
4

9-month and 12-month all-cause mortality

Time frame
9 months and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ANRS, Emerging Infectious Diseases

Lead sponsor

Source ClinicalTrials.gov
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