HIV in Adults
Conditions
Brief summary
The primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat (COBI) alone and in combination as well as oral test formulations containing both ATV and COBI.
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Men and women, ages ≥18 years * Subjects who are qualified professional sensory panelists * Healthy subjects as determined by no clinically significant deviation from normal in medical history and physical assessment
Exclusion criteria
* Any acute or chronic condition that may alter taste or smell sensory perception * Any significant acute or chronic medical illness or any surgery within 4 weeks of the study drug administration * Positive HIV test using an oral swab kit (such as OraQuick®) to detect HIV-1 or -2 antibody
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria | Every 6 weeks from the time of subject enrollment up to 2 years |
| Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria | Every 6 weeks from the time of subject enrollment up to 2 years |
| Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria | Every 6 weeks from the time of subject enrollment up to 2 years |
| Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria | Every 6 weeks from the time of subject enrollment up to 2 years |
| Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria | Every 6 weeks from the time of subject enrollment up to 2 years |
Other
| Measure | Time frame |
|---|---|
| Incident of adverse events will be tabulated and reviewed for potential significance and clinical important | Approximately up to 2 years |
Countries
United States
Outcome results
None listed