HIV Infection Clinical Trial
Official title:
Phase Ib/IIa, Single-Centre, Placebo-Controlled Randomized Study of Safety and Pharmacokinetics in Healthy Volunteers and Safety, Tolerability and Antiviral Activity of VM-1500 in Patients With Human Immunodeficiency Virus-1 Infection
A combined Phase Ib and IIa randomized, placebo-controlled, double-blind study of VM-1500 in healthy subjects and in patients with HIV-1 infection that are antiretroviral therapy naïve.
The study will be split into two parts:
Part I: A randomized, placebo-controlled, single dose, double-blind study in healthy
volunteers with 20 mg followed by 40 mg after DSMB approval.
Healthy group: one dose with 1 PK day 12 health volunteers (total): 6 subjects will
randomized (4:2) to VM-1500 20 mg or placebo. After DSMB approval, 6 subjects will be
randomized (4:2) to VM-1500 40 mg or placebo Part II: A randomized, placebo-controlled,
multiple dose, double-blind study for 7 days in patients with HIV infection who are
antiretroviral therapy-naïve. After positive DMSB review the dose will be escalated from 20
mg to 40 mg once daily.
Patient group: 2 PK days (in-house) at day 1 and day 7 16 patients (total): 8 subjects will
be randomized (7:1) to VM-1500 20 mg or placebo once daily for 7 days. After DSMB approval,
8 subjects will be randomized (7:1) to VM-1500 40 mg or placebo once daily for 7 days.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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