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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02334670
Other study ID # 1U01GH000758
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 5, 2015
Last updated September 12, 2017
Start date August 14, 2015
Est. completion date March 31, 2018

Study information

Verified date September 2017
Source National Hospital for Tropical Diseases, Hanoi, Vietnam
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2612
Est. completion date March 31, 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
Vietnam National Hospital for Tropical Diseases Hanoi

Sponsors (2)

Lead Sponsor Collaborator
National Hospital for Tropical Diseases, Hanoi, Vietnam Centers for Disease Control and Prevention

Country where clinical trial is conducted

Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Primary Six (6) and (12) month all-cause and CM-related mortality among patients who screen CrAg-positive and CrAg-negative Up to 12 months after recruitment
Primary Proportion of all patients tested for plasma CrAg who have positive results Up to 12 months after recruitment
Secondary Percent of patients with HIV-related hospitalizations at 6 and 12 months 12 months after recruitment
Secondary Percent of patients with new AIDS-defining OIs/conditions at 6 and 12 months 12 months after recruitment
Secondary Causes of death 12 months after recruitment
Secondary Six (6) and (12) month retention among patients who screen CrAg-positive and CrAg-negative 12 months after recruitment
Secondary Percentage of patients with CD4= 100 cells/µL who are lost to follow-up or have incomplete documentation 12 months after recruitment
Secondary % of patients with no documented clinic visit 30, 60, and 90 days after date of the scheduled clinic appointment 12 months after recruitment
See also
  Status Clinical Trial Phase
Completed NCT00012467 - Safety and Antifungal Activity of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Cryptococcal Meningitis Phase 2
Completed NCT00002113 - A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis. N/A
Completed NCT00001017 - Comparison of Fluconazole and Amphotericin B in the Treatment of Brain Infections in Patients With AIDS Phase 3
Completed NCT00002075 - Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis N/A
Completed NCT00000776 - Dexamethasone in Cryptococcal Meningitis Phase 2
Completed NCT00000639 - A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis N/A
Completed NCT00000708 - Multi-center Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis N/A
Completed NCT00002076 - Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis N/A
Completed NCT00000677 - SCH 39304 as Therapy for Acute Cryptococcal Meningitis in HIV-Infected Patients Followed by Maintenance Therapy Phase 1
Completed NCT00002040 - Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis N/A
Completed NCT00002316 - The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal Meningitis Phase 1
Completed NCT00002068 - A Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis N/A
Completed NCT00002305 - A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis N/A
Completed NCT00002019 - Safety and Efficacy of Amphotericin B Lipid Complex in the Treatment of Cryptococcal Meningitis in Patients With the Acquired Immunodeficiency Syndrome N/A
Completed NCT00002294 - A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS N/A
Completed NCT00002074 - Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome N/A
Completed NCT00002306 - A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients Who Have Not Had Success With Amphotericin B N/A
Completed NCT00002077 - An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis N/A