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Trial record 47 of 579 for:    meningitis

Pre-Antiretroviral Therapy (ART) Cryptococcal Antigen Screening in AIDS (PreCASA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02624453
Recruitment Status : Active, not recruiting
First Posted : December 8, 2015
Last Update Posted : March 15, 2018
Sponsor:
Collaborators:
Yaounde Central Hospital
St George's, University of London
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

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.

Condition or disease Intervention/treatment Phase
Cryptococcal Meningitis Drug: Fluconazole Drug: Antiretroviral therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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 CD4 Count at the Day Hospital of the Yaounde Central Hospital, Cameroon
Study Start Date : July 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis
Drug Information available for: Fluconazole

Arm Intervention/treatment
Experimental: IMMY LFA positive patients
HIV positive patients who will be positive for cryptococcal antigen (by the IMMY LFA test) would be consented for lumbar puncture in search of cryptococcal meningitis (CM). If CM is not confirmed, they would be prescribed pre-emptive fluconazole based therapy at 800mg/day for two weeks (placed on antiretroviral therapy two weeks after screening for cryptococcal antigen), then 400mg/day for 8 weeks and thereafter 200mg/day until CD4 counts increases beyond 200cells/ml. (CM confirmed cases will be referred to the ACTA trial ISRCTN45035509)
Drug: Fluconazole
Pre-emptive fluconazole therapy at 800mg/day for two weeks, then 400mg/day for eight weeks, and then 200mg/day thereafter till CD4 count goes beyond 200cells/ml
Other Name: cryptococcal antigen positive patients

Drug: Antiretroviral therapy
First line anti-retroviral therapy according to Cameroon national guidelines for the management of HIV/AIDS
Other Name: cryptococcal antigen negative patients

Active Comparator: IMMY LFA negative patients
HIV positive patient who will be negative for cryptococcal antigen (by the IMMY LFA test) would not be consented for lumbar puncture, will be placed immediately on antiretroviral therapy immediately after screening for cryptococcal antigen and would not be placed on fluconazole pre-emptive therapy.
Drug: Antiretroviral therapy
First line anti-retroviral therapy according to Cameroon national guidelines for the management of HIV/AIDS
Other Name: cryptococcal antigen negative patients




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


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


Other Outcome Measures:
  1. Incidence of laboratory confirmed cryptococcal meningitis in the first year [ Time Frame: first year of antiretroviral therapy initial ]
    Incidence of laboratory confirmed cryptococcal meningitis in patients screen cryptococcal antigen positive in the first year of anti-retroviral therapy

  2. Incidence of newly diagnosed and relapsing in all patients in the first year [ Time Frame: first year of antiretroviral therapy initiation ]
    Incidence of newly diagnosed and relapsing, laboratory confirmed, cryptococcal meningitis in the first year after starting ART in patients screened for cryptococcal antigen.

  3. Incidence of mortality within the first year [ Time Frame: first year of antiretroviral therapy initiation ]
    Incidence of mortality within the first year of antiretroviral therapy among cryptococcal antigen screened patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18years
  • HIV 1 and 2 infected but naïve to ART
  • CD4 cell count less than 100 cells/ml
  • No documented past history of cryptococcal meningoencephalitis
  • Acceptance to participate in the study
  • Ambulatory/out patients.

Exclusion Criteria:

  • Patients on ART
  • Pregnant patients
  • Patients with other severe AIDS-associated opportunistic infections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624453


Locations
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Cameroon
Day Hospital of the Yaounde Central Hospital
Yaounde, Central Region, Cameroon, 87
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Yaounde Central Hospital
St George's, University of London
Investigators
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Principal Investigator: Olivier Lortholary, MD, PhD Hôpital Universitaire Necker-Enfants Malades, Molecular Mycology Unit, Institut Pasteur of Paris, and Paris Descartes University, Paris, France
Principal Investigator: Elvis Temfack, MD, MSc Douala General Hospital, Douala, Cameroon and Paris Descartes University, Paris, France
Study Director: Thomas Harrison, MD Infectious Disease Unit, St George's University of London, London, United Kingdom
Study Director: Charles Kouanfack, MD, PhD Day Hospital, Yaoundé Central Hospital, Yaoundé, Cameroon

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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02624453     History of Changes
Other Study ID Numbers: ANRS 12312 PreCASA
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
cryptococcus
IMMY LFA
meningitis
antigen

Additional relevant MeSH terms:
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Meningitis
Meningitis, Cryptococcal
Meningitis, Fungal
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Fungal Infections
Mycoses
Cryptococcosis
Central Nervous System Infections
Anti-Retroviral Agents
Fluconazole
Antiviral Agents
Anti-Infective Agents
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors