A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2016 by Gilead Sciences
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01902472
First received: July 15, 2013
Last updated: February 18, 2016
Last verified: February 2016
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Purpose
This study will evaluate HIV-1 RNA and the presence or absence of resistance at baseline and following seroconversion, assess the frequency of HIV-1 screening and screening method(s) used for evaluation of seroconverters, and collect information regarding whether the seroconverter experienced signs and symptoms of acute HIV-1 infection prior to or at the time of seroconversion.
| Condition |
|---|
|
HIV |
| Study Type: | Observational |
| Study Design: | 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) |
Resource links provided by NLM:
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Seroconversion rate among all subjects exposed to emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF) (Truvada®) for a PrEP indication [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]
- Proportion of seroconverters with resistance mutations [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]
- Proportion of seroconverters with signs/symptoms at or before seroconversion [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2013 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | June 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
FTC/TDF for PrEP
HIV-1 negative adults (any sex/gender, including transgender) who seroconvert while taking FTC/TDF for PrEP
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
One hundred fifty (150) HIV-1 negative adults (any sex/gender, including transgender) and ≥ 18 years of age who seroconvert while taking FTC/TDF for PrEP.
Criteria
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.
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: NCT01902472
Please refer to this study by its ClinicalTrials.gov identifier: NCT01902472
Contacts
| Contact: Rebecca Guzman | rebecca.guzman@gilead.com |
Locations
| United States, California | |
| Gilead Sciences, Inc. | Recruiting |
| Foster City, California, United States, 94404 | |
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | David Magnuson, PharmD | Gilead Sciences |
More Information
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01902472 History of Changes |
| Other Study ID Numbers: | GS-US-276-0103 |
| Study First Received: | July 15, 2013 |
| Last Updated: | February 18, 2016 |
| Health Authority: | United States: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on September 27, 2016