HIV InfectionPhase 1/2NCT02485509
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
A Phase 1/2 study of HIV Infection, run by Viriom at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2013to Dec 2013
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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 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
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- 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.
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 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
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.
Read the 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.
- Conditions
- HIV Infection
- Being tested
- VM-1500/Placebo
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VM-1500/PlaceboDrug
VM-1500 or Placebo
| Study group | Role | What they receive |
|---|---|---|
| 20 mg VM-1500/Placebo Healthy group | Experimental | VM-1500 20 mg or placebo single dose. Receives: Drug: VM-1500/Placebo |
| 40 mg VM-1500/Placebo Healthy group | Experimental | VM-1500 40 mg or placebo single dose. Receives: Drug: VM-1500/Placebo |
| 20 mg VM-1500/Placebo Patient group | Experimental | VM-1500 20 mg or placebo once daily for 7 days. Receives: Drug: VM-1500/Placebo |
| 40 mg VM-1500/Placebo Patient group | Experimental | VM-1500 40 mg or placebo once daily for 7 days. Receives: Drug: VM-1500/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: about one and half month
Dose dependency between VM-1500 plasma levels and corresponding HIV RNA reduction with the administered dosages of VM-1500.
Measured: about one and half month
Virologic activity as measured by plasma HIV RNA following treatment for seven (7) days with VM-1500.
Measured: about one and half month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2013
- Study completionDec 2013
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485509
- Sponsor's protocol ID
- VM-1500-001
- Status last verified
- Jun 2015
- First submitted
- 18 Jun 2015
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02485509
- Acronym / sponsor ID
- VM-1500-001
- Conditions
- HIV Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Jun 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20 mg VM-1500/Placebo Healthy group | Experimental | Drug: VM-1500/PlaceboVM-1500 20 mg or placebo single dose. |
| 40 mg VM-1500/Placebo Healthy group | Experimental | Drug: VM-1500/PlaceboVM-1500 40 mg or placebo single dose. |
| 20 mg VM-1500/Placebo Patient group | Experimental | Drug: VM-1500/PlaceboVM-1500 20 mg or placebo once daily for 7 days. |
| 40 mg VM-1500/Placebo Patient group | Experimental | Drug: VM-1500/PlaceboVM-1500 40 mg or placebo once daily for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 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 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;
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-1500/PlaceboVM-1500 or Placebo | Drug | 20 mg VM-1500/Placebo Healthy group, 20 mg VM-1500/Placebo Patient group, 40 mg VM-1500/Placebo Healthy group, 40 mg VM-1500/Placebo Patient group |
Primary outcome
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
3 secondary outcomes
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
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 30 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of 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 8 inclusion and 17 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 30 Jun 2015. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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). 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 30 Jun 2015.