Status:
UNKNOWN
Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Wellcome Trust
Conditions:
HIV Infections
Tuberculous Meningitis
Eligibility:
All Genders
15+ years
Phase:
NA
Brief 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 ...
Detailed Description
Title: Study of immediate versus deferred antiretroviral therapy in HIV-associated tuberculous meningitis Study design: A randomized, double blind, placebo-controlled trial with 2 parallel arms Sample...
Eligibility Criteria
Inclusion
- age 15 years or older
- HIV antibody positive
- clinical diagnosis of TB meningitis
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00433719
Start Date
September 1 2005
End Date
December 1 2008
Last Update
August 7 2008
Active Locations (2)
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1
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam
2
Pham Ngoc Thach Hospital
Ho Chi Minh City, Vietnam