Using Dexamethasone to Treat Cerebral Toxoplasmosis in HIV Patients
Adjunctive Dexamethasone for Cerebral Toxoplasmosis: a Double-blinded Randomized Controlled Trial
This study is testing if adding dexamethasone to the treatment of cerebral toxoplasmosis can help HIV patients live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitas Padjadjaran Academic / other |
| Locations | 1 site (Bandung, West Java) |
| Trial ID | NCT04341155 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of dexamethasone as an adjunctive therapy for patients with cerebral toxoplasmosis, particularly those who are HIV positive. The study aims to evaluate the impact of dexamethasone on reducing mortality rates associated with this opportunistic infection. Participants will receive either dexamethasone or a placebo, and their clinical outcomes will be monitored to assess the effectiveness of the treatment. The trial seeks to clarify the role of steroids in managing brain edema caused by toxoplasmosis, which has been a subject of debate in previous studies.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive adults aged 18 and older who exhibit clinical signs of cerebral toxoplasmosis and have positive serology for anti-toxoplasma.
Not a fit: Patients with a history of prolonged anti-toxoplasmosis treatment or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality rates in HIV patients suffering from cerebral toxoplasmosis.
How similar studies have performed: Previous studies have shown mixed results regarding the use of adjunctive steroids in cerebral toxoplasmosis, indicating that this trial is addressing an area of uncertainty in treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 years or above. 2. Clinical signs and symptoms compatible to cerebral toxoplasmosis 3. Serology HIV positive 4. Immunoglobulin G anti-toxoplasma titre is positive 5. One or more mass lesions on the neuroradiological finding 6. None or less than 3 days of dexamethasone therapy taken 7. Written informed consent from the patients or from close relatives of the patient if the patient is unconscious. Exclusion Criteria: 1. History of anti-toxoplasmosis administrattion for more than 5 days before recruitment 2. Hypersensitivity or other contraindication to dexamethasone 3. Pregnancy
Where this trial is running
Bandung, West Java
- Hasan Sadikin General Hospital — Bandung, West Java, Indonesia (Recruiting)
Study contacts
- Principal investigator: Sofiati Dian, M.D., PhD — Faculty of Medicine Universitas Padjadjaran Bandung
- Study coordinator: Ahmad R Ganiem, M.D., PhD
- Email: rizalbdg@gmail.com
- Phone: +62 878 2288 3773
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.