Treatment With Tamoxifen in Cryptococcal Meningitis

Summary

The purpose of this study is to develop initial efficacy, feasibility, and safety data regarding the use of Tamoxifen in combination with amphotericin B and fluconazole in the treatment of cryptococcal meningitis. The results of the study will inform the design and feasibility of a larger study powered to a survival endpoint. The study hypothesis is that adding tamoxifen to standard antifungal therapy increases the rate of clearance of yeast from cerebrospinal fluid. Increased rates of clearance of yeast from cerebrospinal fluid have previously been associated with improved clinical outcomes, including survival and disability.

Conditions

• Meningitis Streptococcal
• Hiv
• Meningitis
• Meningoencephalitis

Interventions

DRUG

Tamoxifen

Tamoxifen will be given orally in a dose of 300mg/day for the first 14 days following randomization. It will be administered by nasogastric tube where patients are unconscious. The Tamoxifen will be administered in the morning combined with amphotericin and fluconazole dose.

DRUG

Amphotericin B

Patients will receive amphotericin 1mg/kg/day i.v. once daily orally for the first 2 weeks.

DRUG

Fluconazole

Patients will receive fluconazole 800mg once daily orally for the first 2 weeks. Amphotericin and fluconazole will be administered simultaneously. After the first 2 weeks of study treatment, all patients will receive fluconazole 800mg/day for 8 further weeks, until the study end.

Sponsors & Collaborators

• Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

  collaborator OTHER

• Cho Ray Hospital

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• University of Rochester

  collaborator OTHER

• Liverpool School of Tropical Medicine

  collaborator OTHER

• Oxford University Clinical Research Unit, Vietnam

  lead OTHER

Principal Investigators

• Jeremy Day, MD · Oxford University Clinical Research Unit

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-10

Primary Completion

2018-07-17

Completion

2018-07-17

Countries

• Vietnam

Study Locations