HIV-infectionPhase 1NCT02489487
Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500
A Phase 1 study testing VM-1500, Darunavir and Ritonavir in people with HIV-infection, run by Viriom at 1 site in Thailand.
Trial summary
A randomized single dose, drug-drug interaction study in healthy volunteers for VM - 1500 given alone or in combination with Raltegravir or Darunavir in a 3 arm approach. The parallel design is used due to the long half life for VM-1500. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV-infection
- What is being tested?
- VM-1500, Darunavir and Ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects age between 18-45 years
- Has been determined healthy by physical examination, assessment of drug abuse, medical history and vital signs
- Has normal or acceptable results for the following screening tests: complete blood count (CBC), blood urea nitrogen (BUN), serum creatinine (Cr), fasting blood sugar (FBS), total bilirubin, aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT), alkaline phosphatase (ALP) and urinalysis.
- Negative result for hepatitis A, hepatitis B, hepatitis C and HIV antibodies
- Willing to participate and signed the informed consent form
Who cannot join
- 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 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Siriraj Hospital
Bangkok, Wanglang Road, 10700
About this study
Official title: Phase I, Drug-drug Interaction Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500 When Administered Orally, in Combination With Raltegravir or Darunavir
A randomized single dose, drug-drug interaction study in healthy volunteers for VM - 1500 given alone or in combination with Raltegravir or Darunavir in a 3 arm approach. The parallel design is used due to the long half life for VM-1500.
Read the detailed description
This drug-drug interaction study will not be done as a cross-over study due to the extreme long half life of the drug. The 24 healthy subjects participating will be randomized to VM-1500 alone or VM-1500 in combination with Raltegravir or Darunavir in parallel arms.
For the cohort taking VM-1500 40 mg only just 4 subject will be enrolled as 6 subjects have been already on the same regimen in the trial before. Based on the parallel design it seems appropriate not to expose more healthy subjects than necessary. This means the available data of 6 subjects dosed with 40 mg VM-1500 alone will be matched.
Three groups of healthy subjects will be randomized to VM-1500 alone or VM-1500 in combination with Raltegravir or Darunavir (4:10:10). The healthy subjects will stay at the unit and receive 40 mg VM-1500 alone or VM1500 in combination with Raltegravir or Darunavir one time and PK blood samples at several time points will be collected. PK (trough level) blood samples will also be collected at visits on Days 2, 4,7, 14, 21, and on Day 36.
- Conditions
- HIV-infection
- Being tested
- VM-1500, Darunavir, Ritonavir, Raltegravir
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VM-1500Drug
VM-1500 40 mg
DarunavirDrug
Darunavir 600 mg
RitonavirDrug
Ritonavir 100 mg
RaltegravirDrug
400 mg Raltegravir
| Study group | Role | What they receive |
|---|---|---|
| VM-1500 + Raltegravir | Experimental | VM-1500 40 mg in combination with 400 mg Raltegravir Receives: Drug: VM-1500; Drug: Raltegravir |
| VM-1500 +Darunavir | Experimental | VM-1500 40 mg in combination with 600 mg Darunavir boosted with 100 mg Ritonavir Receives: Drug: VM-1500; Drug: Darunavir; Drug: Ritonavir |
| VM-1500 | Experimental | VM-1500 40 mg alone Receives: Drug: VM-1500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by Division of AIDS table for grading the severity of ADULT Adverse Events
Safety and tolerability of VM-1500 alone or in combination with raltegravir or darunavir in adult healthy subjects
Measured: 36 days
Secondary outcomes (2)
Plasma concentrations of VM-1500 from Day 1 to Day 36
Plasma concentrations of VM-1500 given alone or in combination with raltegravir or darunavir
Measured: 36 days
Plasma concentrations of VM1500A (active metabolite of VM1500) from Day 1 to Day 36
Plasma concentrations of VM-1500A alone or in combination with raltegravir or darunavir
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Somruedee Chatsiricharoenkul, MD, Principal investigator, Acriles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489487
- Sponsor's protocol ID
- VM-1500-002
- Status last verified
- Oct 2018
- First submitted
- 18 Jun 2015
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Drug-drug Interaction Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500 When Administered Orally, in Combination With Raltegravir or Darunavir
- ClinicalTrials.gov ID
- NCT02489487
- Acronym / sponsor ID
- VM-1500-002
- Conditions
- HIV-infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized single dose, drug-drug interaction study in healthy volunteers for VM - 1500 given alone or in combination with Raltegravir or Darunavir in a 3 arm approach. The parallel design is used due to the long half life for VM-1500.
Detailed description
This drug-drug interaction study will not be done as a cross-over study due to the extreme long half life of the drug. The 24 healthy subjects participating will be randomized to VM-1500 alone or VM-1500 in combination with Raltegravir or Darunavir in parallel arms.
For the cohort taking VM-1500 40 mg only just 4 subject will be enrolled as 6 subjects have been already on the same regimen in the trial before. Based on the parallel design it seems appropriate not to expose more healthy subjects than necessary. This means the available data of 6 subjects dosed with 40 mg VM-1500 alone will be matched.
Three groups of healthy subjects will be randomized to VM-1500 alone or VM-1500 in combination with Raltegravir or Darunavir (4:10:10). The healthy subjects will stay at the unit and receive 40 mg VM-1500 alone or VM1500 in combination with Raltegravir or Darunavir one time and PK blood samples at several time points will be collected. PK (trough level) blood samples will also be collected at visits on Days 2, 4,7, 14, 21, and on Day 36.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VM-1500 + Raltegravir | Experimental | Drug: VM-1500, Drug: RaltegravirVM-1500 40 mg in combination with 400 mg Raltegravir |
| VM-1500 +Darunavir | Experimental | Drug: VM-1500, Drug: Darunavir, Drug: RitonavirVM-1500 40 mg in combination with 600 mg Darunavir boosted with 100 mg Ritonavir |
| VM-1500 | Experimental | Drug: VM-1500VM-1500 40 mg alone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male subjects age between 18-45 years
- Has been determined healthy by physical examination, assessment of drug abuse, medical history and vital signs
- Has normal or acceptable results for the following screening tests: complete blood count (CBC), blood urea nitrogen (BUN), serum creatinine (Cr), fasting blood sugar (FBS), total bilirubin, aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT), alkaline phosphatase (ALP) and urinalysis.
- Negative result for hepatitis A, hepatitis B, hepatitis C and HIV antibodies
- Willing to participate and signed the informed consent form
Key exclusion criteria (5 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VM-1500VM-1500 40 mg | Drug | VM-1500, VM-1500 + Raltegravir, VM-1500 +Darunavir |
| DarunavirDarunavir 600 mg | Drug | VM-1500 +Darunavir |
| RitonavirRitonavir 100 mg | Drug | VM-1500 +Darunavir |
| Raltegravir400 mg Raltegravir | Drug | VM-1500 + Raltegravir |
Primary outcome
Number of participants with treatment-related adverse events as assessed by Division of AIDS table for grading the severity of ADULT Adverse Events
Time frame: 36 days
Safety and tolerability of VM-1500 alone or in combination with raltegravir or darunavir in adult healthy subjects
2 secondary outcomes
Plasma concentrations of VM-1500 from Day 1 to Day 36
Time frame: 36 days
Plasma concentrations of VM1500A (active metabolite of VM1500) from Day 1 to Day 36
Time frame: 36 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Somruedee Chatsiricharoenkul, MD principal investigator
Acriles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VM-1500, Darunavir and Ritonavir in people with HIV-infection, run by Viriom at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by Division of AIDS table for grading the severity of ADULT Adverse Events (time frame: 36 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.