HIV Infection
Conditions
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.
Interventions
DRUGVM-1500/Placebo
VM-1500 or Placebo
Sponsors
Viriom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
for Healthy Subjects: 1. Male age between 18-40 years 2. Has been determined healthy by physical examination, assessment of drug abuse, medical history and vital signs 3. Has normal results for the following screening tests: complete blood count , blood urea nitrogen, serum creatinine , fasting blood sugar, total bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase and urinalysis. 4. Negative result for hepatitis B, hepatitis C and HIV antibodies 5. Willing to participate and signed the informed consent form Inclusion Criteria for Patients: 6. Males or females aged 18 to 65 years 7. HIV-1 infection, as documented by a rapid HIV test or any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry 8. Antiretroviral therapy naïve.
Exclusion criteria
for Healthy Subjects: 1. Hepatic or kidney disorders or any other disease or disorder which may in the opinion of the Investigator interfere with the results of the study or threaten the health of volunteers; 2. Drug intake (including herbal drugs) during the last month; 3. Active alcohol or and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements; 4. Volunteers have taken any investigational drug at least 3 month prior to the start of the study; 5. Inability to understand the Protocol or follow its instructions;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) profile of VM-1500 in healthy subjects (Cmax, AUC, T1/2) and in HIV-1-infected patients. | about one and half month |
| 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 |
Countries
Thailand
Outcome results
None listed