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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00976040
Other study ID # THE BOTSHELO STUDY
Secondary ID
Status Completed
Phase Phase 4
First received September 11, 2009
Last updated February 3, 2012
Start date September 2009
Est. completion date December 2011

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
Early antiretroviral therapy
The intervention is early initiation of antiretroviral therapy after diagnosis of Cryptococcal meningitis. In the intervention/experimental arm, triple-drug highly active antiretroviral therapy regimens will be initiated within 7 days of diagnosis of Cryptococcal meningitis.

Locations

Country Name City State
Botswana Princess Marina Hospital,Bamalete Lutheran Hospital and Scottish Livingstone Hospital Gaborone,Ramotswa,Molepolole

Sponsors (3)

Lead Sponsor Collaborator
Botswana-UPenn Partnership Doris Duke Charitable Foundation, University of Pennsylvania

Country where clinical trial is conducted

Botswana, 

Outcome

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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