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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02624453
Date of registration:	04/12/2015
Prospective Registration:	No
Primary sponsor:	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Public title:	Pre-Antiretroviral Therapy (ART) Cryptococcal Antigen Screening in AIDS PreCASA
Scientific 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
Date of first enrolment:	July 2015
Target sample size:	186
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT02624453
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Cameroon

Contacts

Name:	Thomas Harrison, MD
Address:
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Affiliation:	Infectious Disease Unit, St George's University of London, London, United Kingdom

Name:	Charles Kouanfack, MD, PhD
Address:
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Affiliation:	Day Hospital, Yaoundé Central Hospital, Yaoundé, Cameroon

Name:	Olivier Lortholary, MD, PhD
Address:
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Affiliation:	Hôpital Universitaire Necker-Enfants Malades, Molecular Mycology Unit, Institut Pasteur of Paris, and Paris Descartes University, Paris, France

Name:	Elvis Temfack, MD, MSc
Address:
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Affiliation:	Douala General Hospital, Douala, Cameroon and Paris Descartes University, Paris, France

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cryptococcal Meningitis

Intervention(s)

Drug: Antiretroviral therapy

Drug: Fluconazole

Primary Outcome(s)

Prevalence of cryptococcal antigenaemia and antigenuria [Time Frame: at inclusion]

Secondary Outcome(s)

Baseline prevalence of laboratory confirmed Cryptococcal Meningitis [Time Frame: at inclusion]

Secondary ID(s)

ANRS 12312 PreCASA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St George's, University of London

Yaounde Central Hospital

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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