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A randomized once weekly dose for 8 weeks, study in Healthy HIV-Uninfected Volunteers. Each of 3 parallel groups (40 mg, 80 mg and 160mg) enrolls 12 subjects.
The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elpida 40 mg once weekly | Experimental | elsulfavirine 40mg orally once weekly for 8 weeks |
|
| Elpida 80 mg once weekly | Experimental | elsulfavirine 80mg orally once weekly for 8 weeks |
|
| Elpida 160 mg once weekly | Experimental | elsulfavirine 160mg orally once weekly for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elpida | Drug | elsulfavirine, capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs and SAEs | Incidence of AEs and SAEs | 77 days |
| Measure | Description | Time Frame |
|---|---|---|
| elsulfavirine plasma concentration | elsulfavirine plasma concentration | 77 days |
| VM1500A plasma concentration | active metabolite plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Smolyarchuk, MD, PhD | Sechenov First Moscow State Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) | Moscow | 119991 | Russia |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000718630 | elsulfavirine |
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| 77 days |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |