Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The optimal time to initiate antiretroviral therapy (ART) in HIV-associated tuberculous meningitis (TBM) unknown. There are concerns that immediate ART may worsen rather than improve outcome, because drug interactiond and toxicities or development of an intracerebral immune reconstitution inflammatory syndrome (IRIS). Conversely, delaying ART may result in increased HIV-related deaths. To answer this question, we are conducting a randomised, double-blind placebo-controlled trial comparing immediate and deferred ART in HIV-infected patients presenting with TBM, to assess effect on survival.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: Wellcome Trust
• Treatments: Efavirenz; Lamivudine, zidovudine drug combination

Criteria

Inclusion Criteria:

• age 15 years or older

• HIV antibody positive

• clinical diagnosis of TB meningitis

Exclusion Criteria:

• positive CSF Gram or India ink stain

• known or suspected pregnancy

• antituberculous treatment 8 - 30 days immediately prior to recruitment

• previous antiretroviral therapy

• laboratory contraindications to antiretroviral or antituberculous therapy

• lack of consent.