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

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ClinicalTrials.gov Identifier: NCT01865799
Recruitment Status : Active, not recruiting
First Posted : May 31, 2013
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease
Pre-exposure Prophylaxis for Prevention of HIV Infection

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
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
Study Start Date : April 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.


Outcome Measures

Primary Outcome Measures :
  1. Drug utilization of uninfected individuals who are prescribed FTC/TDF for a PrEP indication, including gaps in therapy [ Time Frame: Month 36 ]

Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Demographics of prescribers of FTC/TDF for a PrEP indication [ Time Frame: Months 6, 12, 18, 24, 30, and 36 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865799


Locations
United States, California
Gilead Sciences, Inc.
Foster City, California, United States, 94404
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01865799     History of Changes
Other Study ID Numbers: GS-US-276-0105
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents