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Operational Research for Cryptococcal Antigen Screening

NCT01535469 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3049

Last updated 2020-06-04

No results posted yet for this study

Summary

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

Conditions

  • Cryptococcal Meningitis
  • Cryptococcus Neoformans
  • Cryptococcosis

Interventions

DRUG

Fluconazole

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

Sponsors & Collaborators

Principal Investigators

  • David B Meya, MMed · Makerere University

  • Radha Rajasingham, MD · Infectious Disease Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-01
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Companies

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 NCT01535469 on ClinicalTrials.gov