Taste Properties of HIV Inhibitor | NCT02608918

Studies
Taste Properties of HIV Inhibitor

NCT02608918

Sponsor

ViiV Healthcare

Status

Completed

Last Update Posted

Apr 17, 2018Actual

Enrollment

8Actual

Phase

Phase 1

Conditions

HIV Infections

Interventions

BMS-955176

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AI468-065	Other Identifier	Bristol-Myers Squibb

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 5, 2016Actual

Primary Completion Date

May 24, 2016Actual

Completion Date

May 24, 2016Actual

First Submitted Date

Nov 17, 2015

First Submission Date that Met QC Criteria

Nov 17, 2015

First Posted Date

Nov 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2018

Last Update Posted Date

Apr 17, 2018Actual

Name	Class
Senopsys, LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMS-955176	Experimental	BMS-955176 specified dose on specified days	Drug: BMS-955176

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-955176	Drug		BMS-955176	HIV Maturation Inhibitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Taste properties of HIV Inhibitor will be measured using the Flavor Profile of the Flavor Leadership Criteria		Up to 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Men and women of non-childbearing potential professional sensory panelists
Aged between 25 and 80 years

Exclusion Criteria:

History of relevant drug or food allergies, cardiovascular or Central nervous system (CNS) disease, clinically significant pathology, history of mental illness
Positive HIV test

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Viiv Clinical Trials	ViiV Healthcare	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Woburn	Massachusetts	01801	United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000627567	BMS-955176

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided