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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2024
• Main ID: NCT03092817
• Date of registration: 15/03/2017
• Prospective Registration: Yes
• Primary sponsor: Oxford University Clinical Research Unit, Vietnam
• Public title: Adjunctive Corticosteroids for Tuberculous Meningitis in HIV-infected Adults (The ACT HIV Trial)
• Scientific title: A Randomized Double Blind Placebo Controlled Trial of Adjunctive Dexamethasone for the Treatment of HIV-infected Adults With Tuberculous Meningitis
• Date of first enrolment: May 25, 2017
• Target sample size: 520
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03092817
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 3

Countries of recruitment

Indonesia, Vietnam

Contacts

• Name: Guy Thwaites, MD
• Affiliation: University of Oxford, UK

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult (18 years or older)

- HIV-infected

- Clinical diagnosis of TBM (=5 days of meningitis symptoms, and CSF abnormalities) and
anti-tuberculosis chemotherapy either planned or started by the attending physician

Note: Published diagnostic criteria will be applied to all enrolled participants at the end
of the study when all mycobacterial culture results are available. The criteria will
sub-divide all cases into definite, probable and possible TBM, and those with an
alternative diagnosis.

Exclusion Criteria:

- An additional brain infection (other than TBM) confirmed or suspected: positive CSF
Gram or India Ink stain; positive blood or CSF Cryptococcal antigen test; cerebral
toxoplasmosis suspected and attending physician wants to give anti-toxoplasmosis
treatment with anti-tuberculosis treatment

- More than 6 consecutive days of two or more drugs active against M. tuberculosis
immediately before screening

- More than 3 consecutive days of any type of orally or intravenously administered
corticosteroid immediately before randomisation

- Dexamethasone considered mandatory for any reason by the attending physician

- Dexamethasone considered to be contraindicated for any reason by the attending
physician

- Previously been randomised into the trial for a prior episode of TBM

- Lack of consent from the participant or family member (if the participant is
incapacitated by the disease)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Drug-Induced Liver Injury

HIV

IRIS

Tuberculosis

Tuberculous Meningitis

Intervention(s)

Drug: Dexamethasone

Other: Placebo

Primary Outcome(s)

Overall survival until 12 months after randomisation [Time Frame: 12 months from randomisation]

Secondary Outcome(s)

Neurological disability [Time Frame: by 24 months]

Rate of neurological IRIS events up to 6 months from randomisation [Time Frame: 6 months from randomisation]

Serious adverse events by 12 months [Time Frame: by 12 months]

Time to new AIDS defining event or death [Time Frame: by 24 months]

Neurological disability at 12 months (modified Rankin score) [Time Frame: at 12 months]

HIV-associated malignancy by 12 months [Time Frame: by 12 months]

Time to new AIDS-defining illness or death by 12 months [Time Frame: by 12 months]

Overall survival [Time Frame: by 24 months]

Recurrence of TBM within 24 months of follow-up [Time Frame: 24 months]

Time to new neurological event (defined as a fall in GCS of =2 points for =48 hours, new focal neurological sign, or new onset of seizures) or death by 12 months [Time Frame: by 12 months]

Rate of HIV-related malignancy [Time Frame: by 24 months]

Secondary ID(s)

26TB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

RSUP Persahabatan Hospital, Jakarta, Indonesia

Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Eijkman Oxford Clinical Research Unit, Indonesia

Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam