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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02485509
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Viriom

Tracking Information
First Submitted Date  ICMJE June 18, 2015
First Posted Date  ICMJE June 30, 2015
Last Update Posted Date June 30, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2015)
  • 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 ]
  • 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 ]
  • Virologic activity as measured by plasma HIV RNA following treatment for seven (7) days with VM-1500. [ Time Frame: about one and half month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE HIV Infection
Intervention  ICMJE Drug: VM-1500/Placebo
VM-1500 or Placebo
Study Arms  ICMJE
  • Experimental: 20 mg VM-1500/Placebo Healthy group
    VM-1500 20 mg or placebo single dose.
    Intervention: Drug: VM-1500/Placebo
  • Experimental: 40 mg VM-1500/Placebo Healthy group
    VM-1500 40 mg or placebo single dose.
    Intervention: Drug: VM-1500/Placebo
  • Experimental: 20 mg VM-1500/Placebo Patient group
    VM-1500 20 mg or placebo once daily for 7 days.
    Intervention: Drug: VM-1500/Placebo
  • Experimental: 40 mg VM-1500/Placebo Patient group
    VM-1500 40 mg or placebo once daily for 7 days.
    Intervention: Drug: VM-1500/Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2015)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;

Exclusion Criteria for Patients:

  1. Currently has any active AIDS defining illness
  2. 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.
  3. Patients who are expected to need systemic antiviral therapy at any time during their participation in the study.
  4. 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;
  5. Acute or chronic viral hepatitis;
  6. History or other evidence of renal disease.
  7. Abnormal hematological and biochemical parameters within 30 days of Entry (Day 1).
  8. Screening ECG QTc value 450 ms.
  9. Consumption / administration of concomitant medication.
  10. Active alcohol and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  11. Positive results on urine screen for drugs of abuse at Screening or Day 1
  12. History of immunologically mediated disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02485509
Other Study ID Numbers  ICMJE VM-1500-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Viriom
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Viriom
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Viriom
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP