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Completed

NCT Number: NCT01535469

Operational Research for Cryptococcal Antigen Screening

This will be a stepped wedge randomized trial design to evaluate the implementation of cryptococcal antigen (CRAG) screening and preemptive anti-fungal therapy of HIV-infected persons entering antiretroviral therapy (ART) outpatient treatment in Uganda. Those who are ART eligible with a CD4≤100 cells/mcL will have a serum/plasma CRAG performed by lateral flow assay. Those who are CRAG-positive and asymptomatic will be treated with high dose fluconazole. After 6 months survival with retention-in-care will be compared between those who are CRAG+ and CRAG negative

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Key information

Conditions

Cryptococcal Meningitis Acquired Immunodeficiency Syndrome Bacterial Infections and Mycoses Blood-Borne Infections Central Nervous System Diseases Central Nervous System Fungal Infections Central Nervous System Infections Communicable Diseases Cryptococcosis Cryptococcus Neoformans Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Meningitis Meningitis, Cryptococcal Meningitis, Fungal Mycoses Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Infectious Disease Institute, Makerere University, Kampala, Uganda

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV-1 infection
  • CD4≤100 cells/mcL
  • Cryptococcal antigen (CRAG) positive
  • age >14 years

Exclusion criteria

  • Suspected Cryptococcal meningitis
  • Prior known history of cryptococcal meningitis
  • currently receiving HIV antiretroviral therapy
  • Allergy to any azole antifungal medication
  • Persons with known serious hepatic co-morbidities, transaminitis, or clinical jaundice who should not receive fluconazole in the opinion of the study investigator.
  • Current known pregnancy

Treatment and study plan

Fluconazole

Drug

Fluconazole 800mg orally daily for 2 weeks, then 400mg daily for 8 weeks

Other names: Diflucan

Primary outcomes

  1. Retention in care

    Time frame: 6-month

    • before/after CRAG screening implementation (All persons)
    • CRAG positive persons treated with high-dose fluconazole as compared to 6-month survival of CRAG negative persons who are eligible for antiretroviral therapy.

Secondary outcomes

  1. Cryptococcal meningitis-free survival time

    Time frame: 6-month

    Cryptococcal meningitis-free survival time in those who are asymptomatic CRAG positive and treated with fluconazole compared to CRAG-negative persons with CD4<100 cells/mcL

  2. Survival Time

    Time frame: 6-month

    Survival time among CRAG+ vs. CRAG negative persons with CD4<100 cells/mcL.

  3. Uptake of CRAG screening and preemptive treatment

    Time frame: baseline

  4. Time from CRAG+ test to receipt of fluconazole therapy

    Time frame: Days from CD4 testing

  5. All-cause discontinuation of fluconazole

    Time frame: 6-month

    Number of participants with early discontinuation of fluconazole for any reason (e.g. non-compliance, adverse event)

  6. Percentage of participants with symptomatic cryptococcal meningitis

    Time frame: baseline

  7. Risk factors for symptomatic cryptococcal meningitis

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Infectious Diseases Institute, Uganda
  • Makerere University

Registry information

Official study title

Operational Research for Cryptococcal Antigen Screening to Improve ART Survival

Acronym: ORCAS

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 17, 2012
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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