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Adjunctive Corticosteroids for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial)

NCT03092817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2024-03-22

No results posted yet for this study

Summary

The investigators will conduct a randomized, double blind, placebo controlled trial of adjunctive dexamethasone in the initial (6-8 weeks) treatment of tuberculous meningitis in Vietnamese adults. The trial will address a primary hypothesis in all enrolled patients, and a secondary hypothesis in a sub-group of enrolled patients who develop anti-tuberculosis drug-induced liver injury (DILI). The primary hypothesis is adjunctive dexamethasone increases survival from TBM in HIV co-infected adults. The secondary hypothesis is current guidelines for the management of anti-tuberculosis drug-induced liver injury in those with TBM result in the premature interruption of rifampicin and isoniazid (the critical active drugs in early therapy) and are thereby placing participants at risk of poor outcomes.

Conditions

Interventions

DRUG

Dexamethasone

Active treatment with dexamethasone from randomisation (IV followed by oral according to disease severity at the start of treatment): dexamethasone for intravenous injection and dexamethasone for oral ingestion

OTHER

Placebo

Treatment with matched placebo: Standard saline for intravenous injection and placebo oral tablets containing cellulose

Sponsors & Collaborators

  • Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam

    collaborator OTHER

  • Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

    collaborator OTHER

  • Dr Cipto Mangunkusumo General Hospital

    collaborator OTHER

  • RSUP Persahabatan Hospital, Jakarta, Indonesia

    collaborator UNKNOWN

  • Oxford University Clinical Research Unit Indonesia

    collaborator OTHER

  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER

Principal Investigators

  • Guy Thwaites, MD · University of Oxford, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-25
Primary Completion
2022-04-30
Completion
2023-04-26

Countries

  • Indonesia
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03092817 on ClinicalTrials.gov