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

NCT02624453 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2018-03-15

No results posted yet for this study

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.

Conditions

  • Cryptococcal Meningitis

Interventions

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

DRUG

Antiretroviral therapy

First line anti-retroviral therapy according to Cameroon national guidelines for the management of HIV/AIDS

Sponsors & Collaborators

  • Yaounde Central Hospital

    collaborator OTHER_GOV

  • St George's, University of London

    collaborator OTHER

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Olivier Lortholary, MD, PhD · Hôpital Universitaire Necker-Enfants Malades, Molecular Mycology Unit, Institut Pasteur of Paris, and Paris Descartes University, Paris, France

  • Elvis Temfack, MD, MSc · Douala General Hospital, Douala, Cameroon and Paris Descartes University, Paris, France

  • Thomas Harrison, MD · Infectious Disease Unit, St George's University of London, London, United Kingdom

  • Charles Kouanfack, MD, PhD · Day Hospital, Yaoundé Central Hospital, Yaoundé, Cameroon

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Cameroon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02624453 on ClinicalTrials.gov