Clinical Trials Directory

Trials / Completed

CompletedNCT01865799

A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA

Status
Completed
Phase
Study type
Observational
Enrollment
64,186 (actual)
Sponsor
Gilead Sciences · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Timeline

Start date
2013-04-22
Primary completion
2018-01-22
Completion
2018-01-22
First posted
2013-05-31
Last updated
2018-03-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01865799. Inclusion in this directory is not an endorsement.