A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
This is a prospective, 3-year observational study to describe drug utilization in uninfected individuals (UIs) who initiate emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication.
An electronic source of pharmacy/medical encounter information will be used to assess the demographics and other characteristics of the subjects prescribed FTC/TDF or its components in a prospective fashion. The data provider will supply all the de-identified information regarding each visit/interaction that the subject has had with the health system and all the diagnoses and medications that the UI has had prospectively and retrospectively for the length of time captured by the source selected.
200 physicians who prescribe FTC/TDF for a PrEP indication will be sampled from the same source.
Pre-exposure Prophylaxis for Prevention of HIV Infection
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA|
- Drug utilization of uninfected individuals who are prescribed FTC/TDF for a PrEP indication, including gaps in therapy [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
- Demographics and clinical characteristics of uninfected individuals who are prescribed FTC/TDF for a PrEP indication [ Time Frame: Months 6, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: No ]Demographics (including age, gender and if available, race and ethnicity) and clinical characteristics (including diagnoses, procedures, and laboratory test results) will be summarized by 1) exposure group and 2) overall using descriptive statistics (sample size, mean, standard deviation, median, interquartile range, minimum and maximum) for continuous data, and by the number of participants for categorical data; age will be calculated as age in years at exposure.
- Demographics of prescribers of FTC/TDF for a PrEP indication [ Time Frame: Months 6, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: No ]Demographics (including gender, medical degree, medical specialty, number of years in medical practice, and setting of care) of prescribers of FTC/TDF for a PrEP indication will be summarized using descriptive statistics (sample size, mean, standard deviation, median, interquartile range, minimum and maximum) for continuous data and by the number prescribers for categorical data.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
FTC/TDF for PrEP
This prospective case series is composed of every subject in a database containing de-identified patient-level data from all healthcare channels in the US, of individuals that are exposed to FTC/TDF or its components for any indication.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01865799
|United States, California|
|Gilead Sciences, Inc.|
|Foster City, California, United States, 94404|
|Study Director:||David Magnuson, PharmD||Gilead Sciences|