Pre-exposure Prophylaxis for Prevention of HIV InfectionNCT01865799
A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
An observational study of Pre-exposure Prophylaxis for Prevention of HIV Infection, run by Gilead Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre-exposure Prophylaxis for Prevention of HIV Infection
- How many people
- 64,186 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2013to 22 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria for individuals or prescribers
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gilead Sciences, Inc.
Foster City, California, 94404
About this study
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.
- Keywords
- FTC/TDF, PrEP, Truvada, Drug utilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug utilization of uninfected individuals who are prescribed FTC/TDF for a PrEP indication, including gaps in therapy
Measured: Month 36
Secondary outcomes (2)
Demographics and clinical characteristics of uninfected individuals who are prescribed FTC/TDF for a PrEP indication
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.
Measured: Months 6, 12, 18, 24, 30, and 36
Demographics of prescribers of FTC/TDF for a PrEP indication
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.
Measured: Months 6, 12, 18, 24, 30, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study start22 Apr 2013
- Primary completion22 Jan 2018
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-exposure Prophylaxis for Prevention of HIV InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 64,186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865799
- Sponsor's protocol ID
- GS-US-276-0105
- Status last verified
- Mar 2018
- First submitted
- 22 May 2013
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Drug Utilization Study of Subjects Taking Truvada for Pre-exposure Prophylaxis in the USA
- ClinicalTrials.gov ID
- NCT01865799
- Acronym / sponsor ID
- GS-US-276-0105
- Keywords
- FTC/TDF, PrEP, Truvada, Drug utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64,186 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2013 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- There are no exclusion criteria for individuals or prescribers
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Drug utilization of uninfected individuals who are prescribed FTC/TDF for a PrEP indication, including gaps in therapy
Time frame: Month 36
2 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-exposure Prophylaxis for Prevention of HIV Infection, run by Gilead Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.