The Compartmental Biology of HIV in the Male Genital Tract
Completed
Conditions studied: Human Immunodeficiency Virus, Virus Shedding
In brief
Male participants taking tenofovir-emtricitabine (TDF/FTC) will provide semen and blood samples which will be analyzed to better understand the pharmacology of antiretroviral therapy in the male genital tract.
Key facts
- Study ID
- NCT02638493
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 26
- Starts
- 2015-12-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2017-07-24
Who can join
Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Born male between the ages of 18 and 60
- HIV positive taking TDF/FTC (and a third drug) as treatment; or HIV negative men receiving TDF/FTC as pre-exposure prophylaxis; HIV positive men taking tenofovir alafenamide
- if on routine treatment must have been taking medication for at least 3 months and adherence to medication as assessed by blood plasma HIV RNA less than 50 copies per mL.
- documentation of at least 80% adherence to antiretroviral (ART) regimen, through clinician or self-report, with no missed doses in the 3 days prior to the inpatient visit.
- willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
You may not qualify if…
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that would pose unnecessary risk or interfere with study results.
- unwilling or unable to abstain from sexual activity 72 hours prior to overnight sampling visit
- unlikely to remain on current drug regimen during study period
- anemia that precludes blood donation
- unable to provide semen specimen
- current receipt of other medications that may affect endogenous nucleotide concentrations, such as additional HIV nucleoside reverse transcriptase inhibitors, ribavirin, or adefovir
Where it is running
- University of North Carolina — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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