HIV InfectionsPhase 1NCT03730311
Phase Ib Study of Safety, Tolerability and Pharmacokinetics of Elpida Once Weekly in Healthy Volunteers
A Phase 1 study testing Elpida in people with HIV Infections, run by Viriom at 1 site in Thailand.
Trial summary
A randomized, placebo-controlled, once weekly dose for four weeks, double blind study in Healthy HIV-Uninfected Volunteers. Each of 3 consequent groups (120 mg, 200 mg and 280mg) enrolls 6 active and 2 placebo subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Elpida
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteThailand
- Study dates
- May 2019to Dec 2019
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females aged between 18-40 years.
- Willing and able to complete all study procedures, visits and restrictions.
- Capable of giving written informed consent.
- Has been determined healthy by medical history, physical and vital signs examinations.
- Has normal results for the following screening tests: complete blood count (CBC), sodium, potassium, blood urea nitrogen (BUN), serum creatinine, fasting blood sugar (FBS), creatine kinase, total calcium, cholesterol, triglyceride, total protein, total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and urinalysis.
- Females of reproductive potential (defined as women who have not been postmenopausal for at least 24 consecutive months [i.e., who have had menses within the preceding 24 months], or women who have not undergone surgical sterilization; specifically hysterectomy, salpingotomy, bilateral oophorectomy, and/or tubal ligation), must have a negative serum or urine pregnancy test with a sensitivity of at least 40 mIU/mL at Screening and prior to drug dosing on Day 1.
Show all 11Show fewer
- All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). If participating in sexual activity that could lead to pregnancy, the participant must agree to use two reliable methods of contraception simultaneously while receiving study treatment and for 6 months after stopping study drug. Subjects must either be abstinent or a combination of TWO of the following methods MUST be used appropriately:
- Condoms (male or female) with or without a spermicidal agent;
- Diaphragm or cervical cap with spermicide;
- Intrauterine device (IUD);
- Hormonal-based contraception. Participants who are not of reproductive potential (women who have been postmenopausal for at least 24 consecutive months or have undergone hysterectomy, salpingotomy, bilateral oophorectomy, and/or tubal ligation or men who have documented azoospermia) are eligible without requiring the use of contraceptives. Acceptable documentation of sterilization, menopause or male partner's azoospermia must be provided; serum follicle stimulating hormone (FSH) measurement can be used to document menopausal range.
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.
- Clinically significant ECG abnormality according to ECG exam at Screening, subject's medical history or family history judged by the Investigator that the presence of, or an increased risk of cardiac abnormality.
- Positive result for HIV, HCV or HBV at Screening.
- Positive result for illicit drugs screen (opiates, amphetamines, cannabinoids or cocaine) or alcohol screen at Screening.
- Active alcohol or and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Received the excluded medications (as shown in Appendix 3) within 14 days or 28 days prior to the first dose of study drug, or within the 5 half-lives of individual medication, whichever is longer.
- Participated in a clinical study and received any investigational drug or vaccine or medical device within 90 days prior to the first dose of study drug.
- Pregnancy or breast feeding, male partners of pregnant females. Inability to understand the Protocol or follow its instructions.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Siriraj Hospital
Bangkok
Somruedee Chatsiricharoenkul, Assoc. Prof., MD, +66 (0)2 412 1315
About this study
Official title: Phase Ib, Single-Centre, Placebo-Controlled Randomised Study of Safety, Tolerability and Pharmacokinetics of Elpida in Healthy HIV-Uninfected Volunteers
A randomized, placebo-controlled, once weekly dose for four weeks, double blind study in Healthy HIV-Uninfected Volunteers. Each of 3 consequent groups (120 mg, 200 mg and 280mg) enrolls 6 active and 2 placebo subjects.
Read the detailed description
The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.
- Conditions
- HIV Infections
- Being tested
- Elpida, 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.
ElpidaDrug
Also called elsulfavirine, VM-1500, VM1500
elsulfavirine, capsules
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Elpida 120 mg once weekly | Experimental | elsulfavirine 120mg or placebo orally once weekly for 4 weeks Receives: Drug: Elpida; Drug: placebo |
| Elpida 200 mg once weekly | Experimental | elsulfavirine 200mg or placebo orally once weekly for 4 weeks Receives: Drug: Elpida; Drug: placebo |
| Elpida 280 mg once weekly | Experimental | elsulfavirine 280mg or placebo orally once weekly for 4 weeks Receives: Drug: Elpida; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AEs and SAEs
Incidence of AEs and SAEs
Measured: 36 days
Secondary outcomes (2)
elsulfavirine plasma concentration
elsulfavirine plasma concentration
Measured: 36 days
VM1500A plasma concentration
active metabolite plasma concentration
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 posted5 Nov 2018
- Study startMay 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Somruedee Chatsiricharoenkul, Assoc. Prof., MD, Principal investigator, Siriraj Hospital Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730311
- Sponsor's protocol ID
- HIV-VM1500-11
- Status last verified
- May 2019
- First submitted
- 1 Nov 2018
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib, Single-Centre, Placebo-Controlled Randomised Study of Safety, Tolerability and Pharmacokinetics of Elpida in Healthy HIV-Uninfected Volunteers
- ClinicalTrials.gov ID
- NCT03730311
- Acronym / sponsor ID
- HIV-VM1500-11
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- May 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Nov 2018 (actual)
- 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, placebo-controlled, once weekly dose for four weeks, double blind study in Healthy HIV-Uninfected Volunteers. Each of 3 consequent groups (120 mg, 200 mg and 280mg) enrolls 6 active and 2 placebo subjects.
Detailed description
The study aims to assess safety, tolerability and PK of once weekly administration of Elpida in different doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elpida 120 mg once weekly | Experimental | Drug: Elpida, Drug: placeboelsulfavirine 120mg or placebo orally once weekly for 4 weeks |
| Elpida 200 mg once weekly | Experimental | Drug: Elpida, Drug: placeboelsulfavirine 200mg or placebo orally once weekly for 4 weeks |
| Elpida 280 mg once weekly | Experimental | Drug: Elpida, Drug: placeboelsulfavirine 280mg or placebo orally once weekly for 4 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy males or females aged between 18-40 years.
- Willing and able to complete all study procedures, visits and restrictions.
- Capable of giving written informed consent.
- Has been determined healthy by medical history, physical and vital signs examinations.
- Has normal results for the following screening tests: complete blood count (CBC), sodium, potassium, blood urea nitrogen (BUN), serum creatinine, fasting blood sugar (FBS), creatine kinase, total calcium, cholesterol, triglyceride, total protein, total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and urinalysis.
Key exclusion criteria (8 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.
- Clinically significant ECG abnormality according to ECG exam at Screening, subject's medical history or family history judged by the Investigator that the presence of, or an increased risk of cardiac abnormality.
- Positive result for HIV, HCV or HBV at Screening.
- Positive result for illicit drugs screen (opiates, amphetamines, cannabinoids or cocaine) or alcohol screen at Screening.
- Active alcohol or and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements.
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 |
|---|---|---|
| ElpidaAlso: elsulfavirine, VM-1500, VM1500elsulfavirine, capsules | Drug | Elpida 120 mg once weekly, Elpida 200 mg once weekly, Elpida 280 mg once weekly |
| placeboplacebo | Drug | Elpida 120 mg once weekly, Elpida 200 mg once weekly, Elpida 280 mg once weekly |
Primary outcome
Incidence of AEs and SAEs
Time frame: 36 days
Incidence of AEs and SAEs
2 secondary outcomes
elsulfavirine plasma concentration
Time frame: 36 days
VM1500A plasma concentration
Time frame: 36 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Individual participant dataSharing planned: Undecided
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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, Assoc. Prof., MD principal investigator
Siriraj Hospital Bangkok, Thailand
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 Elpida in people with HIV Infections, 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 11 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tapanee Mahasanprasert (+66(0) 2 412-1315, tapanee.mahasanprasert@aclires.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AEs and SAEs (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 20 May 2019.