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

NCT02624453 | Unknown

• 1 other identifier: ANRS 12312 PreCASA
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Cryptococcal Meningitis

Keywords

cryptococcus; IMMY LFA; meningitis; antigen

Outcome Measures

Primary Outcomes (1)

• Prevalence of cryptococcal antigenaemia and antigenuria

  Prevalence of cryptococcal antigenaemia and antigenuria in HIV patients with CD4 ≤ 100 cells/µL at the Day Hospital of the Yaoundé Central Hospital

  at inclusion

Secondary Outcomes (1)

• Baseline prevalence of laboratory confirmed Cryptococcal Meningitis

  at inclusion

Other Outcomes (3)

• Incidence of laboratory confirmed cryptococcal meningitis in the first year

  first year of antiretroviral therapy initial

• Incidence of newly diagnosed and relapsing in all patients in the first year

  first year of antiretroviral therapy initiation

• Incidence of mortality within the first year

  first year of antiretroviral therapy initiation

Study Arms (2)

IMMY LFA positive patients

EXPERIMENTAL

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; Drug: Antiretroviral therapy

IMMY LFA negative patients

ACTIVE COMPARATOR

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

Interventions

Fluconazole DRUG

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

Also known as: cryptococcal antigen positive patients

IMMY LFA positive patients

Antiretroviral therapy DRUG

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

Also known as: cryptococcal antigen negative patients

IMMY LFA negative patients; IMMY LFA positive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Yaounde Central Hospital: collaborator
• St George's, University of London: collaborator

Study Sites (1)

Day Hospital of the Yaounde Central Hospital

Yaoundé, Central Region, 87, Cameroon

Location

MeSH Terms

Conditions

Meningitis, Cryptococcal; Meningitis

Interventions

Fluconazole; Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Meningitis, Fungal; Central Nervous System Fungal Infections; Mycoses; Bacterial Infections and Mycoses; Infections; Cryptococcosis; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 8, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 15, 2018

Record last verified: 2018-03

Locations

CA (1)