An observational study in Meningitis, Cryptococcal, Central Nervous System Fungal Infections and Central Nervous System Infections, sponsored by National Hospital for Tropical Diseases, Hanoi, Vietnam. Status unknown at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-13.
Sponsored by National Hospital for Tropical Diseases, Hanoi, Vietnam · Observational
It is hypothesized that implementing plasma CrAg screening in clinics providing routine HIV care will enable identification of Vietnamese adult patients with advanced HIV (CD4 ≤100 cells/μL) who have early cryptococcal disease, enable prompt preemptive treatment with high-dose fluconazole, and improve survival.
This is multicenter prospective cohort evaluation of the implementation of a cryptococcal antigen (CrAg) screening program in Vietnam. HIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA) and followed up for 12 months with clinical assessments and the collection of routine and supplemental survey data. Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole. Those with symptoms of CNS disease will be treated according to national guidelines. Survival, retention in care, and other clinical outcomes will be documented for patients who test CrAg-positive and are treated with fluconazole and those who test CrAg-negative.
54 studies on the registry are indexed under Meningitis, Cryptococcal; 6 are open to participants now.
Browse Meningitis, Cryptococcal studies →National Hospital for Tropical Diseases, Hanoi, Vietnam is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Newly registering and ART-naive patients with advanced HIV infection
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with symptoms of CNS disease will be treated according to Vietnam national guidelines for HIV/AIDS management.
Drug: Fluconazole
Patients with CrAg(+) and without CM symptoms will be treated with high-dose fluconazole. The initial dosage of fluconazole will be 900 mg taken each day for 2 weeks. This will be followed by fluconazole 450 mg orally each day for 8 weeks. Finally, maintenance treatment with fluconazole 200mg orally each (2 tablets of 100 mg procured especially for the study) day will continue until CD4 \>200 cells/µL for at least 6 months.
Drug: Fluconazole
Patients with CrAg negative results will be managed as other HIV positive patients according to the national guidelines
Drug: Fluconazole
HIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA). Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole.
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
Proportion of all patients tested for plasma CrAg who have positive results
Time frame: Up to 12 months after recruitment
Percent of patients with HIV-related hospitalizations at 6 and 12 months
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
Causes of death
Time frame: 12 months after recruitment
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
Plan to share: No — Please contact PI for any enquiries
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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National Hospital for Tropical Diseases, Hanoi, Vietnam