HIV Infections Clinical Trial
Official title:
A Randomized Clinical Trial of Immediate Versus Standard Antiretroviral Therapy for HIV-infected Adults Presenting With Cryptococcal Meningitis
The goal of this randomized clinical trial is to compare early versus standard timing of
initiation of antiretroviral therapy (ART) with respect to clearance of Cryptococcus
neoformans from cerebrospinal fluid (CSF) among HIV-infected adults with Cryptococcal
Meningitis.
The investigators hypothesize that early ART mediates more rapid clearance of C. neoformans
from CSF, as manifested by a greater rate of decrease in C. neoformans colony forming units
(CFUs) during the first 28 days after initiating antifungal treatment.
Secondary hypotheses are that recovery of pathogen specific cellular immunity directed at C.
neoformans, as manifested by increases in the number and function of C. neoformans-specific
peripheral blood mononuclear cells is associated with 1) ART and 2) pathogen clearance. In
addition, patients randomized to the intervention arm will have more rapid clearance of
antigen levels in CSF and serum and will have a lower incidence of grade 3 and 4 Adverse
events.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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