A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)
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ClinicalTrials.gov Identifier: NCT01902472 |
Recruitment Status
:
Recruiting
First Posted
: July 18, 2013
Last Update Posted
: April 9, 2018
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Condition or disease |
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HIV |
Study Type : | Observational |
Estimated Enrollment : | 150 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP) |
Actual Study Start Date : | September 2, 2013 |
Estimated Primary Completion Date : | September 2019 |
Estimated Study Completion Date : | September 2019 |

Group/Cohort |
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FTC/TDF for PrEP
HIV-1 negative adults (any sex/gender, including transgender) who seroconvert while taking FTC/TDF for PrEP
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- Seroconversion rate among all subjects exposed to emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF) (Truvada®) for a PrEP indication [ Time Frame: Baseline to Year 3 ]
- Proportion of seroconverters with resistance mutations [ Time Frame: Baseline to Year 3 ]
- Proportion of seroconverters with signs/symptoms at or before seroconversion [ Time Frame: Baseline to Year 3 ]

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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 |
Inclusion Criteria:
- Participant in a FTC/TDF PrEP demonstration project or FTC/TDF for PrEP clinical study
- HIV-1 negative adults (any sex/gender, including transgender) ≥ 18 years of age at time of enrollment in the demonstration project or clinical study.
- Evidence of seroconversion while receiving FTC/TDF for PrEP
Exclusion Criteria:
- This is an observational nested study and will monitor all reported seroconversions without intervention/exclusion.

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): NCT01902472
Contact: Lindsey Smith | Lindsey.Smith@gilead.com |
United States, California | |
Gilead Sciences, Inc. | Recruiting |
Foster City, California, United States, 94404 |
Study Director: | Gilead Study Director | Gilead Sciences |
Responsible Party: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01902472 History of Changes |
Other Study ID Numbers: |
GS-US-276-0103 |
First Posted: | July 18, 2013 Key Record Dates |
Last Update Posted: | April 9, 2018 |
Last Verified: | April 2018 |
Keywords provided by Gilead Sciences:
HIV-1 Truvada FTC/TDF |
Pre-exposure prophylaxy PrEP Resistance |
Additional relevant MeSH terms:
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 |