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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01865799
First received: May 22, 2013
Last updated: October 27, 2016
Last verified: October 2016

May 22, 2013
October 27, 2016
April 2013
June 2017   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01865799 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 of prescribers of FTC/TDF for a PrEP indication including setting of care and prescriber specialty [ Time Frame: Months 6, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

This prospective case series is composed of every subject in the database that is exposed to FTC/TDF or its components for any indication.

Additionally, 200 physicians who prescribe FTC/TDF for a PrEP indication will be randomly sampled from the same source.

Pre-exposure Prophylaxis for Prevention of HIV Infection
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
June 2017
June 2017   (final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Patient/ Uninfected Individual
  • Adult (any sex/gender, including transgender) ≥18 years old
  • Taking FTC/TDF prescribed for any indication or its components Prescriber
  • Possesses an active health care professional license in good standing, with the authority to prescribe prescription medications, either independently (eg, physician) or under legally permissible arrangements for prescribing under physician supervision (eg, Nurse Practitioner or Physician Assistant)
  • Practice site is within the USA
  • Having prescribed FTC/TDF for a PrEP indication

Key Exclusion Criteria:

  • There are no exclusion criteria for individuals or prescribers

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01865799
GS-US-276-0105
No
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP