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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| Gilead Sciences | INDUSTRY |
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This will be a randomized controlled trial of asymptomatic (Cryptococcal Antigen test)CrAg positive persons in Uganda.
Patients will be randomized to receive preemptive treatment with 1 dose of liposomal amphotericin (10mg/kg) in addition to standard of care fluconazole therapy.
How the enhanced antifungal therapy prevents progression to meningitis in the first 24-weeks and overall survival in those who receive the intervention compared with participants receiving fluconazole per World Health Organisation (WHO) and national standard of care therapy will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose liposomal Amphotericin and fluconazole | Experimental | Experimental: Single dose Ambisome 10mg/kg and Fluconazole 800mg for two weeks ,400mg for 8 weeks and 200mg upto 6 months. (standard of care therapy) |
|
| fluconazole (standard of care) | Active Comparator | Standard of care pre-emptive treatment fluconazole 800mg for two weeks ,400mg for 8 weeks and 200mg upto 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose liposomal Amphotericin and Fluconazole | Drug | Intravenous Single dose of 10mg/kg of Ambisome and fluconazole as per WHO guidelines for six months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients that develop meningitis in the AMBISOME arm compared to the fluconazole arm. | Comparison will be made between those randomized to single dose liposomal amphotericin + standard of care (fluconazole) vs. standard of care (fluconazole) alone | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of grade 3 to 5 clinical adverse events or serious adverse events | Symptoms causing inability to perform social and functional activities and potentially life threatening symptoms requiring intervention or hospitalization. | within two weeks of enrollment |
| Number of grade 3 to 5 laboratory adverse events by NIAID DAIDS toxicity scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DAVID MEYA, PhD | Contact | +256 772 543 730 | david.meya@gmail.com | |
| ELIZABETH NALINTYA, MPH | Contact | +256 771 321 617 | enalintya@idi.co.ug |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| infectious Disease Institute Kampala,Uganda | Recruiting | Kampala | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39044381 | Derived | Meya DB, Nalintya E, Skipper CP, Kirumira P, Ayebare P, Naluyima R, Namuli T, Turya F, Walukaga S, Engen N, Hullsiek KH, Wele A, Dai B, Boulware DR, Rajasingham R. Adjunctive Single-Dose Liposomal Amphotericin to Prevent Cryptococcal Meningitis in People With HIV-Associated Cryptococcal Antigenemia and Low Plasma Cryptococcal Antigen Titers. Clin Infect Dis. 2025 Feb 5;80(1):129-136. doi: 10.1093/cid/ciae266. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 13, 2021 | Dec 1, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D016919 | Meningitis, Cryptococcal |
| ID | Term |
|---|---|
| D016921 | Meningitis, Fungal |
| D020314 | Central Nervous System Fungal Infections |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000666 | Amphotericin B |
| D015725 | Fluconazole |
| C068538 | liposomal amphotericin B |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
| Fluconazole | Drug | Fluconazole 800mg for 2 weeks,400mg for 8 weeks and 200mg up to six months |
|
Abnormal laboratory findings that meet the DAIDS categorization of grade 3 and 4. |
| within two weeks of enrollment |
| Cost-effectiveness of single dose liposomal amphotericin + fluconazole compared to fluconazole preemptive therapy alone, and compared to no preemptive therapy. | what will be the added cost required to treat patients with AMBISOME when assessed in light of the outcomes. | 24 weeks |
| Number of patients that will survive in the 24-week period. | How many patients will be alive at 24 weeks when the two arms are compared. | 24 weeks |
| D007239 | Infections |
| D003453 | Cryptococcosis |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| D014230 |
| Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |