Three Induction Treatments on Cryptococcal Meningitis

HIV/AIDS Clinical Trial

— TITOC  

Official title:

The Effect and Safety of Three Initial Introduction Treatments on HIV-infected Patients With Cryptococcal Meningitis: A Multi-center, Random and Prospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04072640
• Other study ID #: 2018-014-1
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: January 25, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2021
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Three induction treatment strategies [ voriconazole +5FC vs. amphotericin deoxycholate (0.4-0.5 mg/kg/d)+5FC vs. amphotericin deoxycholate (0.7-1.0 mg/kg/d)+5FC ] for HIV-infected patients with cryptococcal meningitis were compared.

Description:

HIV-associated cryptococcal meningitis were randomly allocated into three induction treatment as follow: 1) 14 days of voriconazole 200mg bid +5FC, 2) 28 days of amphotericin deoxycholate (0.4-0.5 mg/kg/d) +5FC ; 3）14 days of deoxycholate (0.7-1 mg/kg/d) +5FC). After induction treatment were finished, all groups switched into fluconazole(400mg/d) for two-month consolidation treatment. 14-day early fungicidal rate, 90-day mortality, side effects , and tolerances were compared between three groups.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 1, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of HIV infection;

2. newly diagnosed Cryptococcal Meningitis by positive India ink staining or culture result, or both in cerebrospinal fluid (CSF);

3. Anti-viral treatment naïve patients

4. anti-fungal treatment naïve patients

Exclusion Criteria:

1. hepatitis virus co-infection;

2. liver cirrhosis;

3. congestive heart failure;

4. chronic renal disorders;

5. chronic obstructive pulmonary disease (COPD);

6. Tuberculosis co-infection;

7. malignances

8. severe mental and neurological diseases

9. Women during pregnancy and lactation

10. intraveneous drug user (IDU)

11. patients with follow abnormal test results:hemoglobin < 6 g/dl, white blood cell count < 2000 / µl, neutrophil count < 1000 / µl, platelet count < 75000 / µl, blood amylase > 3 times normal level Upper limit, serum creatinine > 1.5 times normal upper limit, aspartate aminotransferase / alanine aminotransferase / alkaline phosphatase > 3 times normal upper limit, total bilirubin > 2 times normal upper limit

12. patients who are unwilling to anticipate.

Related Conditions & MeSH terms

• Cryptococcal Meningitis
• HIV/AIDS
• Meningitis
• Meningitis, Cryptococcal
• Meningococcal Infections

Intervention

Drug:
• Voriconazole 200mg
Induction treatment with voriconazole( 400mg/d)+5FC (100mg/kg/d) for 14 days;
• amphotericin B deoxycholate (0.4-0.5mg/kg/d)
Induction treatment with 0.4-0.5mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 28 days
• Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)
Induction treatment with 0.7-1.0mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 14 days

Locations

Country	Name	City	State
China	Lijun Xu	Zhenjiang	Hangzhou

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	Wenzhou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day Cryptococcal Meningitis (CM) related mortality	analysis of 90-day CM-related mortality of patients in three induction treatments	90 days
Secondary	Early fungicidal rate in Cerebrospinal fluid (CSF)	Comparison of 2-week CSF early fungicidal activity in three induction treatments	2 weeks
Secondary	creatinine elevation	TO observe the numbers of patients whose creatinine > 110 mmol/L during antifungal therapy	0-90 days
Secondary	Hypokalemia	To observe the rate of hypokalemia in three groups during antifungal therapy	0-90 days
Secondary	anemia	Comparison of the numbers of patients with hemoglobin <120g/L for male or <110g/L for female.	0-90 days