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
Primary Purpose
HIV Infection
Status
Completed
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
VM-1500/Placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection
Eligibility Criteria
Inclusion Criteria for Healthy Subjects:
- Male age between 18-40 years
- Has been determined healthy by physical examination, assessment of drug abuse, medical history and vital signs
- 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.
- Negative result for hepatitis B, hepatitis C and HIV antibodies
Willing to participate and signed the informed consent form
Inclusion Criteria for Patients:
- Males or females aged 18 to 65 years
- 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
- Antiretroviral therapy naïve.
Exclusion Criteria for Healthy Subjects:
- 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;
- Drug intake (including herbal drugs) during the last month;
- Active alcohol or and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements;
- Volunteers have taken any investigational drug at least 3 month prior to the start of the study;
- Inability to understand the Protocol or follow its instructions;
Exclusion Criteria for Patients:
- Currently has any active AIDS defining illness
- Exclusionary resistance mutations defined as evidence of any major NNRTI mutations according to the current IAS list of HIV-1 Resistance Mutations Associated with Drug Resistance on any genotype; or evidence of significant NNRTI resistance on any phenotype performed at any time prior to study entry.
- Patients who are expected to need systemic antiviral therapy at any time during their participation in the study.
- Patients who have received an investigational drug for HIV, HIV vaccine, immunomodulators, systemic cytotoxic chemotherapy, or other investigational therapy within 30 days prior to study entry;
- Acute or chronic viral hepatitis;
- History or other evidence of renal disease.
- Abnormal hematological and biochemical parameters within 30 days of Entry (Day 1).
- Screening ECG QTc value 450 ms.
- Consumption / administration of concomitant medication.
- Active alcohol and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Positive results on urine screen for drugs of abuse at Screening or Day 1
- History of immunologically mediated disease.
Sites / Locations
- Faculty of Medicine, Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
20 mg VM-1500/Placebo Healthy group
40 mg VM-1500/Placebo Healthy group
20 mg VM-1500/Placebo Patient group
40 mg VM-1500/Placebo Patient group
Arm Description
VM-1500 20 mg or placebo single dose.
VM-1500 40 mg or placebo single dose.
VM-1500 20 mg or placebo once daily for 7 days.
VM-1500 40 mg or placebo once daily for 7 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pharmacokinetic (PK) profile of VM-1500 in healthy subjects (Cmax, AUC, T1/2) and in HIV-1-infected patients.
Dose dependency between VM-1500 plasma levels and corresponding HIV RNA reduction with the administered dosages of VM-1500.
Virologic activity as measured by plasma HIV RNA following treatment for seven (7) days with VM-1500.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02485509
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viriom
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
20 mg VM-1500/Placebo Healthy group
Arm Type
Experimental
Arm Description
VM-1500 20 mg or placebo single dose.
Arm Title
40 mg VM-1500/Placebo Healthy group
Arm Type
Experimental
Arm Description
VM-1500 40 mg or placebo single dose.
Arm Title
20 mg VM-1500/Placebo Patient group
Arm Type
Experimental
Arm Description
VM-1500 20 mg or placebo once daily for 7 days.
Arm Title
40 mg VM-1500/Placebo Patient group
Arm Type
Experimental
Arm Description
VM-1500 40 mg or placebo once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
VM-1500/Placebo
Intervention Description
VM-1500 or Placebo
Primary Outcome Measure Information:
Title
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.
Time Frame
about one and half month
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) profile of VM-1500 in healthy subjects (Cmax, AUC, T1/2) and in HIV-1-infected patients.
Time Frame
about one and half month
Title
Dose dependency between VM-1500 plasma levels and corresponding HIV RNA reduction with the administered dosages of VM-1500.
Time Frame
about one and half month
Title
Virologic activity as measured by plasma HIV RNA following treatment for seven (7) days with VM-1500.
Time Frame
about one and half month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Healthy Subjects:
Male age between 18-40 years
Has been determined healthy by physical examination, assessment of drug abuse, medical history and vital signs
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.
Negative result for hepatitis B, hepatitis C and HIV antibodies
Willing to participate and signed the informed consent form
Inclusion Criteria for Patients:
Males or females aged 18 to 65 years
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
Antiretroviral therapy naïve.
Exclusion Criteria for Healthy Subjects:
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;
Drug intake (including herbal drugs) during the last month;
Active alcohol or and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements;
Volunteers have taken any investigational drug at least 3 month prior to the start of the study;
Inability to understand the Protocol or follow its instructions;
Exclusion Criteria for Patients:
Currently has any active AIDS defining illness
Exclusionary resistance mutations defined as evidence of any major NNRTI mutations according to the current IAS list of HIV-1 Resistance Mutations Associated with Drug Resistance on any genotype; or evidence of significant NNRTI resistance on any phenotype performed at any time prior to study entry.
Patients who are expected to need systemic antiviral therapy at any time during their participation in the study.
Patients who have received an investigational drug for HIV, HIV vaccine, immunomodulators, systemic cytotoxic chemotherapy, or other investigational therapy within 30 days prior to study entry;
Acute or chronic viral hepatitis;
History or other evidence of renal disease.
Abnormal hematological and biochemical parameters within 30 days of Entry (Day 1).
Screening ECG QTc value 450 ms.
Consumption / administration of concomitant medication.
Active alcohol and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Positive results on urine screen for drugs of abuse at Screening or Day 1
History of immunologically mediated disease.
Facility Information:
Facility Name
Faculty of Medicine, Siriraj Hospital
City
Bangkok
State/Province
Wanglang Road
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
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
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