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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00976040 |
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Date of registration:
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11/09/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Optimal Time to Start Antiretroviral Therapy in HIV-infected Adults With Cryptococcal Meningitis
Crypto |
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Scientific title:
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A Randomized Clinical Trial of Immediate Versus Standard Antiretroviral Therapy for HIV-infected Adults Presenting With Cryptococcal Meningitis |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00976040 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Botswana
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Contacts
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Name:
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Pablo Tebas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Botswana-UPenn Partnership, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania |
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Name:
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Gregory P Bisson, MD,MSCE |
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Address:
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Telephone:
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Email:
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Affiliation:
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Botswana-UPenn Partnership, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania |
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Key inclusion & exclusion criteria
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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.
Age minimum:
21 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cryptococcal Meningitis
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HIV Infections
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Intervention(s)
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Other: Early antiretroviral therapy
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Primary Outcome(s)
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Change in the CSF CFUs between the immediate and standard ART initiation groups
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Grade 3 or 4 adverse events
[Time Frame: 6 months]
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Clearance of C. neoformans antigen from CSF and blood.
[Time Frame: 6 months]
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Change in the number of peripheral blood mononuclear cells responding to C. neoformans
[Time Frame: 4 weeks]
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Secondary ID(s)
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THE BOTSHELO STUDY
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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