Clinical trial NCT04072640: Three Induction Treatments on Cryptococcal Meningitis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Cryptococcal Meningitis
HIV/AIDS
Keywords: Voriconazole;amphotericin ;cryptococcal meningitis
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Wenzhou Central Hospital
First posted: 2019-08-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 90-day Cryptococcal Meningitis (CM) related mortality
timeFrame: 90 days
Secondary outcomes:
measure: Early fungicidal rate in Cerebrospinal fluid (CSF)
timeFrame: 2 weeks
measure: creatinine elevation
timeFrame: 0-90 days
measure: Hypokalemia
timeFrame: 0-90 days
measure: anemia
timeFrame: 0-90 days
Other outcomes:
Locations:
city: Zhenjiang
country: China
facility: Lijun Xu
state: Hangzhou
Study officials:
affiliation: Zhejiang University
name: Lijun Xu, PH.D
role: PRINCIPAL_INVESTIGATOR
References: