Clinical Outcomes of Cryptococcal Meningitis Among HIV-infected Patients in the Era of Antiretroviral Therapy

NCT02098525 | Completed

• 1 other identifier: HIVCM-01
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

Cryptococcal meningitis is one of the most common central nervous system infections among HIV-infected patients. The outcome is generally severe. This study aims to determine long-term survival rate among HIV-infected CM patients in the era of antiretroviral therapy (ART). The secondary objectives are to clarify outcomes of CM and determine prognostic factors.

Conditions

Cryptococcal Meningitis; HIV/AIDS

Keywords

Cryptococcal meningitis; HIV/AIDS; Antiretroviral therapy; Prognosis; Thailand

Outcome Measures

Primary Outcomes (1)

• Long-term survival rate of CM

  To describe long-term survival rate of CM among adult HIV-infected patients in the era of ART.

  Up to 12 years. Cases will be censored at the date of last visit if they are lost to follow up or referred to another hospital, and will be censored at the date of death.

Secondary Outcomes (1)

• Risk factors of short-term and long-term mortality of CM

  Up to 12 years. Cases will be censored at the date of last visit if they are lost to follow up or referred to another hospital, and will be censored at the date of death.

Study Arms (1)

HIV associated CM patients

The study population is all adult HIV positive patients with CM at Ramathibodi Hospital.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population is all adult HIV positive patients with CM at Ramathibodi Hospital, Mahidol University.

You may qualify if:

• HIV-infected patients diagnosed by positive results of 2 different ELISA tests, 1 ELISA test accompanied with 1 HIV-PCR test, or 1 ELISA test accompanied with 1 Western blot test, whose age was more than 15 years old.
• Newly diagnosed CM during the study period defined by positive culture, positive Indian ink or positive latex agglutination test on CSF with typical symptoms at Ramathibodi Hospital.

You may not qualify if:

• Patients who had other known CNS co-infection or other significant concurrent CNS diseases which might influence on outcome of CM.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Meningitis, Cryptococcal; Acquired Immunodeficiency Syndrome

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; Meningitis; Neuroinflammatory Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Taiichiro Kobayashi, Dr

  Mahidol University

  PRINCIPAL INVESTIGATOR

• Punnee Pitisuttithum, Prof.

  Mahidol University

  STUDY DIRECTOR

• Weerawat Manosuthi, Dr.

  Bamrasnaradura infectious disease hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 28, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

TH (1)