A Prospective, Observational Study of Individuals Who Seroconvert While Taking Truvada® for Pre-Exposure Prophylaxis (PrEP)
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | September 2, 2013 |
| End Date: | March 2020 |
| Contact: | Lindsey Smith |
| Email: | Lindsey.Smith@gilead.com |
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.
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.
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.
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