This trial is active, not recruiting.

Condition pre-exposure prophylaxis for prevention of hiv infection
Sponsor Gilead Sciences
Start date April 2013
End date June 2017
Trial size 400 participants
Trial identifier NCT01865799, GS-US-276-0105


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
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.

Primary Outcomes

Drug utilization of uninfected individuals who are prescribed FTC/TDF for a PrEP indication, including gaps in therapy
time frame: Month 36

Secondary Outcomes

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 of prescribers of FTC/TDF for a PrEP indication
time frame: Months 6, 12, 18, 24, 30, and 36

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.