NCT02608918

Brief Summary

The purpose of the study is to assess the taste properties of HIV inhibitor

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 hiv-infections

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

January 5, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2016

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

November 17, 2015

Last Update Submit

April 13, 2018

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Taste properties of HIV Inhibitor will be measured using the Flavor Profile of the Flavor Leadership Criteria

    Up to 2 years

Study Arms (1)

BMS-955176

EXPERIMENTAL

BMS-955176 specified dose on specified days

Drug: BMS-955176

Interventions

BMS-955176DRUG
Also known as: HIV Maturation Inhibitor
BMS-955176

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Woburn, Massachusetts, 01801, United States

Location

Related Links

MeSH Terms

Conditions

HIV Infections

Interventions

BMS-955176

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Viiv Clinical Trials

    ViiV Healthcare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2015

First Posted

November 20, 2015

Study Start

January 5, 2016

Primary Completion

May 24, 2016

Study Completion

May 24, 2016

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

US(1)