Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
16 December 2017 |
Main ID: |
NCT02334670 |
Date of registration:
|
05/01/2015 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Vietnam Cryptococcal Retention in Care Study Version 1.0
CRICS |
Scientific title:
|
Evaluation of a Public Health Strategy to Improve Survival of HIV Infected Patients |
Date of first enrolment:
|
August 14, 2015 |
Target sample size:
|
2612 |
Recruitment status: |
Active, not recruiting |
URL:
|
https://clinicaltrials.gov/show/NCT02334670 |
Study type:
|
Observational |
Study design:
|
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Vietnam
| | | | | | | |
Contacts
|
Name:
|
Nguyen Van Kinh, MD, PhD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
National Hospital for Tropical Diseases |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Aged = 18 years
- Confirmed HIV infection using National Testing Algorithm
- CD4 =100 cells/µL
- Able to provide written informed consent
Exclusion Criteria:
- History of prior CM
- Receipt of systemic antifungal medication for more than 4 consecutive weeks within the
past 6 months
- Currently taking ART or history of ART for more than 4 weeks within the past year
- Known to be currently pregnant or planning to become pregnant during the study period
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Central Nervous System Infections
|
Central Nervous System Fungal Infections
|
Meningitis, Cryptococcal
|
Meningitis, Fungal
|
Intervention(s)
|
Drug: Fluconazole
|
Primary Outcome(s)
|
Proportion of all patients tested for plasma CrAg who have positive results
[Time Frame: Up to 12 months after recruitment]
|
Six (6) and (12) month all-cause and CM-related mortality among patients who screen CrAg-positive and CrAg-negative
[Time Frame: Up to 12 months after recruitment]
|
Secondary Outcome(s)
|
Six (6) and (12) month retention among patients who screen CrAg-positive and CrAg-negative
[Time Frame: 12 months after recruitment]
|
Percentage of patients with CD4= 100 cells/µL who are lost to follow-up or have incomplete documentation
[Time Frame: 12 months after recruitment]
|
% of patients with no documented clinic visit 30, 60, and 90 days after date of the scheduled clinic appointment
[Time Frame: 12 months after recruitment]
|
Percent of patients with HIV-related hospitalizations at 6 and 12 months
[Time Frame: 12 months after recruitment]
|
Causes of death
[Time Frame: 12 months after recruitment]
|
Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months
[Time Frame: 12 months after recruitment]
|
Secondary ID(s)
|
1U01GH000758
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|