Human Immunodeficiency VirusNCT02638493

The Compartmental Biology of HIV in the Male Genital Tract

An observational study of Human Immunodeficiency Virus and Virus Shedding, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus, Virus Shedding
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Dec 2015to Oct 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
Men only
Healthy volunteers accepted
Adult

Study population: HIV positive and HIV negative men taking TDF/FTC once daily, HIV positive men taking TAF/FTC once daily

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: IGHID 11526 - The Compartmental Biology of HIV in the Male Genital Tract

Read the detailed description

8 HIV positive men taking TDF/FTC and 8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis will provide multiple semen and blood samples during a 48-hour inpatient visit. 8 HIV positive men taking TAF (tenofovir alafenamide) will provide multiple semen and blood samples during a 48-hour inpatient visit.

Participants will take part in the study for approximately two months. After the screening visit, there is one 2 day overnight visit for intensive PK/PD (pharmacokinetic/pharmacodynamic) sampling. The investigators will study drug concentrations and intracellular endogenous nucleotide concentrations (dATP and dCTP) in seminal plasma and (where appropriate) seminal cells.

Samples will be analyzed through the use of novel laboratory methods to determine the seminal plasma and seminal cell concentrations of tenofovir and emtricitabine. New technologies will be used to better understand compartmental and intracellular antiretroviral pharmacology of nucleoside/tide reverse transcriptase inhibitors. Pharmacokinetic modeling will be used to estimate the primary outcomes.

Conditions: Human Immunodeficiency Virus, Virus Shedding
Keywords: HIV, tenofovir-emtricitabine, antiretroviral therapy, Prevention, tenofovir alafenamide
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02638493
Study group	Role	What they receive
HIV positive TDF/FTC		8 HIV positive men taking TDF/FTC as treatment
HIV negative		8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
HIV Positive TAF		8 HIV positive men taking TAF as treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Semen Clearance (CL) of Tenofovir
Samples will be analyzed for drug concentrations at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate clearance from semen from a 300mg dose of tenofovir.
Measured: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose
Semen Clearance (CL) of Emtricitabine
Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate clearance from semen from a 200mg dose of emtricitabine.
Measured: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose
Semen Clearance (CL) of Tenofovir Diphosphate
Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of tenofovir diphosphate, an intracellular metabolite of tenofovir, from seminal mononuclear cells, following a 300mg dose of tenofovir.
Measured: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose
Semen Clearance (CL) of Emtricitabine Triphosphate
Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of emtricitabine triphosphate, an intracellular metabolite of emtricitabine, from seminal mononuclear cells, following a 200mg dose of emtricitabine.
Measured: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose
Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Tenofovir Diphosphate
Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of tenofovir diphosphate, an intracellular metabolite of tenofovir, from peripheral blood mononuclear cells, following a 300mg dose of tenofovir.
Measured: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose
Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Emtricitabine Triphosphate
Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of emtricitabine triphosphate, an intracellular metabolite of emtricitabine, from peripheral blood mononuclear cells, following a 200mg dose of emtricitabine.
Measured: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose

Secondary outcomes (2)

Tenofovir Diphosphate (TFVdp)/Deoxyadenosine Triphosphate (dATP) Ratio in Seminal Mononuclear Cells
dATP concentrations in seminal mononuclear cells will be measured and compared to tenofovir diphosphate concentrations, using a ratio, and summarized descriptively for each subject, as well as across subjects. As the six seminal cell samples collected per man were pooled for analysis due to low cell recovery, a single ratio value per participant was calculated and summarized by study arm.
Measured: Average concentration in a 24 hour dosing interval
Emtricitabine Triphosphate (FTCtp)/Deoxyadenosine Triphosphate (dCTP) Ratio in Seminal Mononuclear Cells
dCTP concentrations in seminal mononuclear cells will be measured and compared to emtricitabine triphosphate concentrations, using a ratio, and summarized descriptively for each subject, as well as across subjects. As the six seminal cell samples collected per man were pooled for analysis due to low cell recovery, a single ratio value per participant was calculated and summarized by study arm.
Measured: Average concentration in a 24 hour dosing interval

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Oct 2016

First posted23 Dec 2015 (estimated)
Study startDec 2015
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02638493
Sponsor's protocol ID: 15-2767
Other IDs: R01DK108424-01
Status last verified: Apr 2017
First submitted: 10 Dec 2015
Last updated: 24 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Galvin SR, Cohen MS. The role of sexually transmitted diseases in HIV transmission. Nat Rev Microbiol. 2004 Jan;2(1):33-42. doi: 10.1038/nrmicro794.
PubMed 15035007
Cohen MS, Gay C, Kashuba AD, Blower S, Paxton L. Narrative review: antiretroviral therapy to prevent the sexual transmission of HIV-1. Ann Intern Med. 2007 Apr 17;146(8):591-601. doi: 10.7326/0003-4819-146-8-200704170-00010.
PubMed 17438318
Anderson DJ, Politch JA, Nadolski AM, Blaskewicz CD, Pudney J, Mayer KH. Targeting Trojan Horse leukocytes for HIV prevention. AIDS. 2010 Jan 16;24(2):163-87. doi: 10.1097/QAD.0b013e32833424c8. No abstract available.
PubMed 20010071
Joseph SB, Swanstrom R, Kashuba AD, Cohen MS. Bottlenecks in HIV-1 transmission: insights from the study of founder viruses. Nat Rev Microbiol. 2015 Jul;13(7):414-25. doi: 10.1038/nrmicro3471. Epub 2015 Jun 8.
PubMed 26052661
Tompkins LAR, Khoei A, Kapeljushnik O, Dumond J, Kashuba ADM, Tropsha A, Hubal R, Cottrell ML. HIV Pharmacology Data Repository: Setting the New Information-Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies. Clin Pharmacol Ther. 2025 Dec;118(6):1340-1349. doi: 10.1002/cpt.3699. Epub 2025 May 12.
PubMed 40354181

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IGHID 11526 - The Compartmental Biology of HIV in the Male Genital Tract
ClinicalTrials.gov ID: NCT02638493
Acronym / sponsor ID: 15-2767
Conditions: Human Immunodeficiency Virus, Virus Shedding
Keywords: HIV, tenofovir-emtricitabine, antiretroviral therapy, Prevention, tenofovir alafenamide
Study type: Observational
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Dec 2015 (actual)
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 23 Dec 2015 (estimated)
Results: Posted 24 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
HIV positive TDF/FTC	–	–8 HIV positive men taking TDF/FTC as treatment
HIV negative	–	–8 HIV negative men taking TDF/FTC as pre-exposure prophylaxis
HIV Positive TAF	–	–8 HIV positive men taking TAF as treatment

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult
Study population: HIV positive and HIV negative men taking TDF/FTC once daily, HIV positive men taking TAF/FTC once daily

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Semen Clearance (CL) of Tenofovir
Time frame: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose
Samples will be analyzed for drug concentrations at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate clearance from semen from a 300mg dose of tenofovir.
Semen Clearance (CL) of Emtricitabine
Time frame: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose
Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate clearance from semen from a 200mg dose of emtricitabine.
Semen Clearance (CL) of Tenofovir Diphosphate
Time frame: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose
Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of tenofovir diphosphate, an intracellular metabolite of tenofovir, from seminal mononuclear cells, following a 300mg dose of tenofovir.
Semen Clearance (CL) of Emtricitabine Triphosphate
Time frame: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose
Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of emtricitabine triphosphate, an intracellular metabolite of emtricitabine, from seminal mononuclear cells, following a 200mg dose of emtricitabine.
Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Tenofovir Diphosphate
Time frame: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose
Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of tenofovir diphosphate, an intracellular metabolite of tenofovir, from peripheral blood mononuclear cells, following a 300mg dose of tenofovir.
Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Emtricitabine Triphosphate
Time frame: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose
Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of emtricitabine triphosphate, an intracellular metabolite of emtricitabine, from peripheral blood mononuclear cells, following a 200mg dose of emtricitabine.

2 secondary outcomes

Tenofovir Diphosphate (TFVdp)/Deoxyadenosine Triphosphate (dATP) Ratio in Seminal Mononuclear Cells
Time frame: Average concentration in a 24 hour dosing interval
Emtricitabine Triphosphate (FTCtp)/Deoxyadenosine Triphosphate (dCTP) Ratio in Seminal Mononuclear Cells
Time frame: Average concentration in a 24 hour dosing interval

Results and safety

Results posted to the registry on 24 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HIV Positive TDF/FTC	10	8
HIV Negative	8	8
HIV Positive TAF	8	8

Primary outcome: Semen Clearance (CL) of Tenofovir

Time frame: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose. Median (Inter-Quartile Range). Unit: L/hr

Measure	HIV Positive TDF/FTC n = 8	HIV Negative n = 8	HIV Positive TAF n = 8
Value	33.88 (18.86 to 65.26)	51.21 (19.18 to 77.79)	5.65 (3.23 to 7.23)

Primary outcome: Semen Clearance (CL) of Emtricitabine

Time frame: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose. Median (Inter-Quartile Range). Unit: L/hr

Measure	HIV Positive TDF/FTC n = 8	HIV Negative n = 8	HIV Positive TAF n = 8
Value	5.91 (5.43 to 8.28)	8.72 (4.95 to 12.30)	7.12 (3.91 to 11.09)

Primary outcome: Semen Clearance (CL) of Tenofovir Diphosphate

Time frame: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose. Median (Inter-Quartile Range). Unit: fmol/10x6 cells

Measure	HIV Positive TDF/FTC n = 8	HIV Negative n = 8	HIV Positive TAF n = 8
Value	21 (5.7 to 88)	21 (4.2 to 91)	35 (24 to 78)

Primary outcome: Semen Clearance (CL) of Emtricitabine Triphosphate

Time frame: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose. Median (Inter-Quartile Range). Unit: fmol/10 E6 cells

Measure	HIV Positive TDF/FTC n = 8	HIV Negative n = 8	HIV Positive TAF n = 8
Value	59 (22 to 119)	90 (34 to 193)	179 (108 to 395)

Population analysed: Semen (SMC) Steady State Concentrations (Css,ave) of Emtricitabine Triphosphate

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of informed consent, until end of study enrollment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV Positive TDF/FTC	0 of 8 (0%)	0 of 8 (0%)	0 of 8
HIV Negative	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8
HIV Positive TAF	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15035007Galvin SR, Cohen MS. The role of sexually transmitted diseases in HIV transmission. Nat Rev Microbiol. 2004 Jan;2(1):33-42. doi: 10.1038/nrmicro794.
Background: PubMed 17438318Cohen MS, Gay C, Kashuba AD, Blower S, Paxton L. Narrative review: antiretroviral therapy to prevent the sexual transmission of HIV-1. Ann Intern Med. 2007 Apr 17;146(8):591-601. doi: 10.7326/0003-4819-146-8-200704170-00010.
Background: PubMed 20010071Anderson DJ, Politch JA, Nadolski AM, Blaskewicz CD, Pudney J, Mayer KH. Targeting Trojan Horse leukocytes for HIV prevention. AIDS. 2010 Jan 16;24(2):163-87. doi: 10.1097/QAD.0b013e32833424c8. No abstract available.
Background: PubMed 26052661Joseph SB, Swanstrom R, Kashuba AD, Cohen MS. Bottlenecks in HIV-1 transmission: insights from the study of founder viruses. Nat Rev Microbiol. 2015 Jul;13(7):414-25. doi: 10.1038/nrmicro3471. Epub 2015 Jun 8.
Derived from this study: PubMed 40354181Tompkins LAR, Khoei A, Kapeljushnik O, Dumond J, Kashuba ADM, Tropsha A, Hubal R, Cottrell ML. HIV Pharmacology Data Repository: Setting the New Information-Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies. Clin Pharmacol Ther. 2025 Dec;118(6):1340-1349. doi: 10.1002/cpt.3699. Epub 2025 May 12.
University of North Carolina websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julie Dumond, PharmD, MS principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus and Virus Shedding, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Semen Clearance (CL) of Tenofovir (time frame: Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02638493, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.