HIV InfectionsPhase 1NCT02608918
Taste Properties of HIV Inhibitor
A Phase 1 study testing BMS-955176 in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial summary
The purpose of the study is to assess the taste properties of HIV inhibitor Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- BMS-955176
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2016to 24 May 2016
- 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women of non-childbearing potential professional sensory panelists
- Aged between 25 and 80 years
Who cannot join
- History of relevant drug or food allergies, cardiovascular or Central nervous system (CNS) disease, clinically significant pathology, history of mental illness
- Positive HIV test
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Woburn, Massachusetts, 01801
About this study
Official title: An Open-Label Taste Assessment of BMS-955176 in Healthy Subjects
The purpose of the study is to assess the taste properties of HIV inhibitor
- Conditions
- HIV Infections
- Being tested
- BMS-955176
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-955176Drug
Also called HIV Maturation Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| BMS-955176 | Experimental | BMS-955176 specified dose on specified days Receives: Drug: BMS-955176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste properties of HIV Inhibitor will be measured using the Flavor Profile of the Flavor Leadership Criteria
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start5 Jan 2016
- Primary completion24 May 2016
- Study completion24 May 2016
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.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Senopsys, LLC
- Responsible party
- Sponsor
- Investigators
- Viiv Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608918
- Sponsor's protocol ID
- 206301
- Other IDs
- AI468-065
- Status last verified
- Apr 2018
- First submitted
- 17 Nov 2015
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Taste Assessment of BMS-955176 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02608918
- Acronym / sponsor ID
- 206301
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Senopsys, LLC
- Study start
- 5 Jan 2016 (actual)
- Primary completion
- 24 May 2016 (actual)
- Study completion
- 24 May 2016 (actual)
- First posted
- 20 Nov 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.
The purpose of the study is to assess the taste properties of HIV inhibitor
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-955176 | Experimental | Drug: BMS-955176BMS-955176 specified dose on specified days |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women of non-childbearing potential professional sensory panelists
- Aged between 25 and 80 years
Key exclusion criteria (2 listed)
- History of relevant drug or food allergies, cardiovascular or Central nervous system (CNS) disease, clinically significant pathology, history of mental illness
- Positive HIV test
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 |
|---|---|---|
| BMS-955176Also: HIV Maturation Inhibitor | Drug | BMS-955176 |
Primary outcome
Taste properties of HIV Inhibitor will be measured using the Flavor Profile of the Flavor Leadership Criteria
Time frame: Up to 2 years
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 17 Apr 2018.
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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.
Viiv Clinical Trials study director
ViiV Healthcare
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 BMS-955176 in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
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 2 inclusion and 2 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 17 Apr 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 United States. 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?
Taste properties of HIV Inhibitor will be measured using the Flavor Profile of the Flavor Leadership Criteria (time frame: Up to 2 years). 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 17 Apr 2018.