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
- Conditions
- HIV Infection
- Interventions
- Drug: VM-1500/Placebo
- Registration Number
- NCT02485509
- Lead Sponsor
- Viriom
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 40 mg VM-1500/Placebo Healthy group VM-1500/Placebo VM-1500 40 mg or placebo single dose. 20 mg VM-1500/Placebo Healthy group VM-1500/Placebo VM-1500 20 mg or placebo single dose. 20 mg VM-1500/Placebo Patient group VM-1500/Placebo VM-1500 20 mg or placebo once daily for 7 days. 40 mg VM-1500/Placebo Patient group VM-1500/Placebo VM-1500 40 mg or placebo once daily for 7 days.
- Primary Outcome Measures
Name Time Method Safety and tolerability of VM-1500 in adult healthy subjects and in patients with early-stage chronic HIV-1 infection based on analysis of AEs, laboratory values. about one and half month
- Secondary Outcome Measures
Name Time Method Dose dependency between VM-1500 plasma levels and corresponding HIV RNA reduction with the administered dosages of VM-1500. about one and half month Virologic activity as measured by plasma HIV RNA following treatment for seven (7) days with VM-1500. about one and half month Pharmacokinetic (PK) profile of VM-1500 in healthy subjects (Cmax, AUC, T1/2) and in HIV-1-infected patients. about one and half month
Trial Locations
- Locations (1)
Faculty of Medicine, Siriraj Hospital
🇹🇭Bangkok, Wanglang Road, Thailand