HIV Infections Clinical Trial
— CryptoOfficial title:
A Randomized Clinical Trial of Immediate Versus Standard Antiretroviral Therapy for HIV-infected Adults Presenting With Cryptococcal Meningitis
Verified date | February 2012 |
Source | Botswana-UPenn Partnership |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | December 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 80 Years |
Eligibility |
Inclusion Criteria: - HIV 1 infection confirmed by licensed ELISA kit and/or detectable Viral load. - Confirmed Cryptococcal meningitis on the current admission by India ink or CSF cryptococcal antigen - ART naive at the time of enrollment - 21 years old and above - Ability and willingness to give written informed consent to participate in the study - Able (as assessed by the patient's medical team)to initiate amphotericin B for cryptococcal meningitis - Initiated amphotericin B 72 hours or less prior to assessment for enrollment or not on amphotericin B at the time of assessment for enrollment - Agrees to obtain outpatient care after discharge within 50 kilometers from Princess Marina Hospital,Scottish Livingstone Hospital and Bamalete Lutheran Hospital Exclusion Criteria: - Recent (within the past 4 weeks) antifungal use - Pregnant or breastfeeding - Initiated anti-tubercular therapy 2 weeks or less prior to assessment for enrollment. - Bacterial meningitis at the time of assessment for enrollment. - Recent (within the past 1 month) use of the following:systemic cancer chemotherapy,oral or intravenous corticosteroids or other immunomodulators. - Judged by study coordinator to be likely to initiate chemotherapy or any other immunomodulatory therapy prior to the 4 week LP. - Imprisoned. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Botswana | Princess Marina Hospital,Bamalete Lutheran Hospital and Scottish Livingstone Hospital | Gaborone,Ramotswa,Molepolole |
Lead Sponsor | Collaborator |
---|---|
Botswana-UPenn Partnership | Doris Duke Charitable Foundation, University of Pennsylvania |
Botswana,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the CSF CFUs between the immediate and standard ART initiation groups | 4 weeks | No | |
Secondary | Grade 3 or 4 adverse events | each participant is followed up for 6 months after the initiation of HAART | 6 months | Yes |
Secondary | Clearance of C. neoformans antigen from CSF and blood. | 6 months | No | |
Secondary | Change in the number of peripheral blood mononuclear cells responding to C. neoformans | 4 weeks | No |
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