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
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
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 18, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedJune 30, 2015
June 1, 2015
9 months
June 18, 2015
June 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (4)
20 mg VM-1500/Placebo Healthy group
EXPERIMENTALVM-1500 20 mg or placebo single dose.
40 mg VM-1500/Placebo Healthy group
EXPERIMENTALVM-1500 40 mg or placebo single dose.
20 mg VM-1500/Placebo Patient group
EXPERIMENTALVM-1500 20 mg or placebo once daily for 7 days.
40 mg VM-1500/Placebo Patient group
EXPERIMENTALVM-1500 40 mg or placebo once daily for 7 days.
Interventions
VM-1500 or Placebo
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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;
- Currently has any active AIDS defining illness
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viriomlead
Study Sites (1)
Faculty of Medicine, Siriraj Hospital
Bangkok, Wanglang Road, 10700, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2015
First Posted
June 30, 2015
Study Start
March 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
June 30, 2015
Record last verified: 2015-06