Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Niacin · 1 trial · 1 indication
The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24.
| Arm | Type | Description |
|---|---|---|
| Arm A: Extended-release niacin with aspirin | EXPERIMENTAL | - |
| Arm B: Fenofibrate | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Niacin | DRUG | Extended-release niacin will be given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) |
| Aspirin | DRUG | Aspirin 325 mg will be given by mouth in the evening with extended-release niacin through week 24. |
| Fenofibrate | DRUG | Fenofibrate will be administered as 200 mg by mouth once daily for 24 weeks. |
Inclusion Criteria: * HIV-1 infection * Currently on continuous ART for ≥48 weeks. * CD4+ cell count ≥100/mm3 obtained within 60 days prior to study entry. * Most recent HIV-1 RNA below the limit of detection using an ultrasensitive licensed or FDA-approved assay obtained within 60 days prior to st...
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Niacin is being studied for use in HIV-1 Infection. It is an investigational small molecule in Phase 2 clinical development. The drug is being evaluated for its effects on endothelial function, lipoproteins, and inflammation in patients with HIV-1 infection who have low HDL cholesterol.
Niacin is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The company is conducting clinical research to evaluate the drug's potential in treating HIV-1 Infection.
Niacin is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for its safety and efficacy in patients with HIV-1 Infection.
Niacin has been studied in one clinical trial with the identifier NCT01426438. This Phase 2 trial, titled "Endothelial Function, Lipoproteins, and Inflammation With Low HDL Cholesterol in HIV: ER Niacin Versus Fenofibrate," was completed in the United States. The trial enrolled 99 participants with HIV-1 Infection.
Yes, Niacin is also known as ER Niacin, which stands for extended-release niacin. In the clinical trial NCT01426438, the drug is referred to as ER Niacin. This alternative name is used to describe the extended-release formulation of the drug being studied.
Niacin works by targeting lipid metabolism and inflammatory pathways. It is being studied for its effects on endothelial function, lipoproteins, and inflammation in patients with HIV-1 infection who have low HDL cholesterol. The drug's mechanism of action is relevant to cardiovascular risk in this patient population.