Trial record 11 of 36 for:    " May 15, 2013":" June 14, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01865799
First received: May 22, 2013
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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 he 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.


Condition
Pre-exposure Prophylaxis for Prevention of HIV Infection

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 400
Study Start Date: May 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

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

Exclusion Criteria:

  • There are no exclusion criteria for individuals or prescribers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865799

Contacts
Contact: Robertino Mera +1 (650) 522-5056 Robertino.Mera@gilead.com

Locations
United States, California
Gilead Sciences, Inc. Recruiting
Foster City, California, United States, 94404
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01865799     History of Changes
Other Study ID Numbers: GS-US-276-0105
Study First Received: May 22, 2013
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
FTC/TDF
PrEP
Truvada
Drug utilization

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014