Clinical Trial: Pre-Antiretroviral Therapy (ART) Cryptococcal Antigen Screening in AIDS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Implementation and Evaluation of a Screening Strategy to Reduce Morbidity and Mortality Due to Cryptoccocal Meningo-encephalitis in ART Naive AIDS Patients With <100 CD

Brief Summary: The aim of the study is to evaluate systematic pre-antiretroviral cryptococcal antigen screening and pre-emptive fluconazole therapy in antigen positive patients, as a strategy to reduce morbidity and mortality due to AIDS associated cryptococcal meningitis in patients starting antiretroviral therapy at <100 CD4 in Cameroon.

Detailed Summary:

Cryptococcal meningitis (CM) is a leading cause of death in AIDS patients in much of the developing world, responsible for up to 500,000 deaths each year in sub-Saharan Africa alone. Introduction of antiretroviral therapy (ART) has reduced the number of cases of cryptococcal meningitis in the developed world. Unfortunately, in many low resource settings, patients continue to present late to ART treatment programs with advanced immunosuppression, and many die of HIV-related illness in the weeks just prior to, and months following, initiation of ART. Cryptococcal meningitis causes many of these deaths, and is also a heavy burden on healthcare facilities. Treatment of the disease remains inadequate, with an acute mortality of between 20 and 50%, even with the best current treatment.

Many of these cases of cryptococcal meningitis may be preventable. Recent research has shown that routine screening for sub-clinical infection, using a simple test (cryptococcal antigen or CRAG) in patients presenting to ART programmes, can identify which patients are at risk of developing cryptococcal meningitis. Once identified, these patients could then be given safe oral "pre-emptive" treatment to prevent them developing a severe form of the disease. This strategy has many advantages over the alternative preventative measure, called generalised primary prophylaxis, which involves giving all profoundly immune depressed HIV-infected patients preventative treatment. Using a primary prophylaxis strategy, large numbers of patients are given medication, many of whom don't need it, and there are problems of cost and development of drug resistance and drug interactions. In a targeted strategy, only patients who benefit most from the treatment will be given medication.

The investigators propose to study the feasibility and effectiveness of CR
Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AID

Current Primary Outcome: Prevalence of cryptococcal antigenaemia and antigenuria in HIV patients with CD4 ≤ 100 cells/µL at the Day Hospital of the Yaoundé Central Hospital [ Time Frame: at inclusion ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Baseline prevalence of laboratory confirmed Cryptococcal Meningitis among patients screened positive for Cryptococcal antigen [ Time Frame: at inclusion ]

Original Secondary Outcome: Same as current

Information By: French National Institute for Health and Medical Research-French National Agency for Research on AID

Dates:
Date Received: December 4, 2015
Date Started: July 2015
Date Completion: August 2017
Last Updated: July 11, 2016
Last Verified: July 2016