N/A
N=26
The Compartmental Biology of HIV in the Male Genital Tract
Human Immunodeficiency Virus · Virus Shedding
Bottom Line
View on ClinicalTrials.gov: NCT02638493 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Semen Clearance (CL) of Tenofovir — 33.88; 51.21; 5.65 L/hr
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Semen Clearance (CL) of Tenofovir |
33.88; 51.21; 5.65 | — |
| PRIMARY Semen Clearance (CL) of Emtricitabine |
5.91; 8.72; 7.12 | — |
| PRIMARY Semen Clearance (CL) of Tenofovir Diphosphate |
21; 21; 35 | — |
| PRIMARY Semen Clearance (CL) of Emtricitabine Triphosphate |
59; 90; 179 | — |
| PRIMARY Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Tenofovir Diphosphate |
174; 119; 935 | — |
| PRIMARY Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Emtricitabine Triphosphate |
6038; 6135; 8242 | — |
| SECONDARY Tenofovir Diphosphate (TFVdp)/Deoxyadenosine Triphosphate (dATP) Ratio in Seminal Mononuclear Cells |
0.99; 0.66; 1.10 | — |
| SECONDARY Emtricitabine Triphosphate (FTCtp)/Deoxyadenosine Triphosphate (dCTP) Ratio in Seminal Mononuclear Cells |
0.52; 0.96; 3.81 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02638493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.