HivSHAMTNCT02983110
Sex Hormone Therapy and Mucosal Tissues
An observational study of Hiv, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this research study is to better understand how sex hormone therapy that is used to treat women for menopausal symptoms, men with low testosterone, or as hormone therapy for transgender women, affects a class of medications called NRTIs (nucleoside reverse transcriptase inhibitors) used to treat and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hiv
- What is being tested?
- Anoscopy with Rectal Tissue Sampling, Phlebotomy and Female Genital Tract Sampling
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 15 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will consist of 20 HIV positive men and women between 18-65 years of age (inclusive) with an intact gastrointestinal tract, uterus/cervix (if cisgender women), and male genital tract (if cisgender man) who are available to complete all study procedures at UNC.
Who may be able to join
- -
- All subjects eligible to enroll must meet the following inclusion criteria, regardless of cohort:
- HIV-positive adults aged 18-65, inclusive on the date of screening, clinically healthy, with an intact gastrointestinal tract. Any screening test may be repeated once in the screening window to confirm or verify eligibility.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all the pertinent details of the study.
- Willing and able to comply with scheduled visits, treatment plan laboratory tests, and other trial procedures
- Subjects must not be actively involved in the conception process, currently pregnant/lactating/ or in the immediate post-partum period.
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- Subjects must be willing to abstain from all sexual activity, and all intravaginal and intrarectal products for at least 72 hours prior to the sampling day, until seven days later
- HIV RNA viral load undetectable (<50 copies/mL or less per institution) within at least the previous six months prior to screening. Repeat HIV RNA Viral load testing may be conducted at screening, if indicated.
- -->80% adherent to their antiretroviral regimen per self-report, and a compliant diary card 5 days before intensive sampling
- Actively adherent to an antiretroviral regimen containing both tenofovir (TDF) and emtracitabine (FTC) for >1 month (if switched from previous regimen) or >3 months (if previously antiretroviral naive) as part of their standard clinic care
- Negative, or treated, sexually transmitted infections at screening including syphilis, gonorrhea, chlamydia, and trichomoniasis
- All subjects must have an estimated calculated creatinine clearance of (eCcr) at least 60mL/min by the Cockcroft-Gault formula
- No clinical or surgical abnormalities (i.e. hysterectomy) that would preclude sample collection
- Hemoglobin Grade 2 or lower, with no clinical significant medical issues that would preclude blood sampling
- Coagulation testing Grade 2 or lower, with no clinically significant medical issues that would preclude tissue sampling
Who cannot join
- Age outside of desired range
- Subject is HIV negative
- Impaired renal function, as documented with a creatinine clearance <60mL/min with the Cockcroft-Gault equation
- Receiving an antiretorivral regimen that does not include TDF/FTC, or adherent to a TDF/FTC regimen less than one month, or patient is unlikely to remain on this regimen during the sampling period
- Less than 80% adherence to anti-retroviral medications, and more than 3 missed doses in the month preceding enrollment
- Subject is not able or willing to follow the diet and lifestyle guidelines necessary for the study period
Show all 9Show fewer
- Active, untreated, sexually transmitted infection, including syphilis, gonorrhea, chlamydia or trichomoniasis or symptomatic bacterial vaginosis
- Clinical, laboratory, or surgical abnormalities that would preclude sample collection (for example but not limited to: hysterectomy)
- Subjects actively involved in the conception process, currently pregnant or lactating, or immediately post-partum
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Research Center, UNC Hospitals
Chapel Hill, North Carolina, 27599
About this study
Official title: Does Sex Hormone Therapy Decrease Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Active Metabolite Formation in Mucosal Tissues?
The purpose of this research study is to better understand how sex hormone therapy that is used to treat women for menopausal symptoms, men with low testosterone, or as hormone therapy for transgender women, affects a class of medications called NRTIs (nucleoside reverse transcriptase inhibitors) used to treat and prevent HIV infection. The two most commonly used NRTIs are tenofovir and emtricitabine, which are the components of the drug Truvada and also included in the combination products Atripla, Complera, and Stribild. The medication's ability to work effectively may be altered when someone is also taking sex hormone therapy.
In order to determine this effect, samples will be collected from some parts of the body where HIV makes copies. These samples will be measured for the levels of HIV medication, HIV virus and sex hormones that are present. The samples that will be looked at in this study include blood, cells from the vagina, semen, and tissue biopsies from the female genital tract and rectum.
Read the detailed description
Study Design:
This is an observational study of tenofovir/emtricitabine (TFV/FTC) concentrations in the genital and lower gastrointestinal tracts. Participants will be selected on the basis of receiving TFV/FTC as part of their ongoing HIV care. After participant education, informed consent, and screening for study eligibility, participants will be evaluated at baseline. All samples will be collected over the course of an outpatient sampling visit.
Study Sampling:
- A blood sample will be collected to measure the concentration of TFV/FTC in the blood plasma, the concentration of TFV/FTC active metabolite concentrations (TFVdp/FTCtp) in the PBMCs, and the concentration of sex hormones in the blood stream.
- Vaginal and cervical tissue will be collected (for cisgender women) to measure for concentrations of TFVdp/FTCtp, HIV RNA, and estrogen/progesterone.
- Rectal tissue samples will be collected to measure for concentrations of TFVdp/FTCtp, HIV RNA, estrogen/progesterone (for cisgender and transgender women), and testosterone (for cisgender men).
- A semen sample will be collected (for cisgender men) to measure the concentrations of TFV/FTC, HIV RNA and testosterone.
Pharmacokinetic Analysis:
All blood, cervical, vaginal, semen and rectal tissue samples will be analyzed by the Clinical Pharmacology and Analytical Chemistry Laboratory (CPAC) at the UNC School of Pharmacy. TFV/FTC will be measured in blood and seminal plasma and TFVdp/FTCtp will be measured in PBMCs, SMCs using validated LC-MS/MS methods. HIV RNA will be measured in blood and seminal plasma using the Abbott Real Time HIV-1 quantitative assay. HIV RNA within the cervical and seminal cells and rectal tissues will be measured using an established Droplet Digital PCR method. Estradiol and progesterone will be measured in serum using validated florescent immunoassays.
- Conditions
- Hiv
- Being tested
- Anoscopy with Rectal Tissue Sampling, Phlebotomy, Female Genital Tract Sampling
- Keywords
- Hormones, Transgender
- 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.
Anoscopy with Rectal Tissue SamplingProcedure or surgery
All subjects will provide 10 pieces of rectal tissue
PhlebotomyProcedure or surgery
- Procedure: Blood plasma/serum collection Approximately 17 mL of blood will be taken from each subject just prior to tissue sampling.
Female Genital Tract SamplingProcedure or surgery
Cohorts B only will have cervical cells, cervical tissue, and vaginal tissue collected
| Study group | Role | What they receive |
|---|---|---|
| Cohort B | Group B will be HIV Infected post-menopausal women who are not receiving hormonal therapy to provide tissue, blood, and cells Receives: Procedure: Anoscopy with Rectal Tissue Sampling; Procedure: Phlebotomy; Procedure: Female Genital Tract Sampling | |
| Cohort C | Group C will be HIV infected transgendered women receiving hormone therapy to provide tissue and blood Receives: Procedure: Anoscopy with Rectal Tissue Sampling; Procedure: Phlebotomy | |
| Cohort E | Group E will be HIV infected men Receives: Procedure: Anoscopy with Rectal Tissue Sampling; Procedure: Phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of tenofovir/emtricitabine active metabolite (TFVdp/FTCtp) concentrations in ectocervical/vaginal (cisgender women) and rectal (all cohorts) tissue biopsies by LC-MS/MS.
(TFVdp/FTCtp)
Measured: Samples collected within 24 hours post-dose
Quantification of tenofovir/emtricitabine active metabolite (TFVdp/FTCtp) concentrations in PBMCs (all cohorts) and seminal mononuclear cells (cisgender men).
PBMC concentrations
Measured: Samples collected within 24 hours post-dose
Secondary outcomes (2)
Quantification of HIV RNA concentrations
in the female tract cells (cisgender women), seminal cells (cisgender men) and rectal tissue (all cohorts) by Droplet Digital PCR method and within seminal (cisgender men) and blood plasma (all cohorts) by Abbott R
Measured: Samples collected within 24 hours post-dose
Quantification of estradiol/progesterone (cisgender and transgender women) and testosterone (cisgender men) concentrations in blood serum.
hormone concentrations
Measured: Samples collected within 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion1 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HivStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mackenzie Cottrell, PharmD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983110
- Sponsor's protocol ID
- 16-2122
- Acronym
- SHAMT
- Status last verified
- Dec 2018
- First submitted
- 2 Dec 2016
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cottrell ML, Yang KH, Prince HM, Sykes C, White N, Malone S, Dellon ES, Madanick RD, Shaheen NJ, Hudgens MG, Wulff J, Patterson KB, Nelson JA, Kashuba AD. A Translational Pharmacology Approach to Predicting Outcomes of Preexposure Prophylaxis Against HIV in Men and Women Using Tenofovir Disoproxil Fumarate With or Without Emtricitabine. J Infect Dis. 2016 Jul 1;214(1):55-64. doi: 10.1093/infdis/jiw077. Epub 2016 Feb 24.
PubMed 26917574Nicol MR, Fedoriw Y, Mathews M, Prince HM, Patterson KB, Geller E, Mollan K, Mathews S, Kroetz DL, Kashuba AD. Expression of six drug transporters in vaginal, cervical, and colorectal tissues: Implications for drug disposition in HIV prevention. J Clin Pharmacol. 2014 May;54(5):574-83. doi: 10.1002/jcph.248. Epub 2014 Jan 2.
PubMed 24343710Cottrell ML, Prince HM, Allmon A, Mollan KR, Hudgens MG, Sykes C, White N, Malone S, Dellon ES, Madanick RD, Shaheen NJ, Patterson KB, Kashuba AD. Cervicovaginal and Rectal Fluid as a Surrogate Marker of Antiretroviral Tissue Concentration: Implications for Clinical Trial Design. J Acquir Immune Defic Syndr. 2016 Aug 15;72(5):498-506. doi: 10.1097/QAI.0000000000000996.
PubMed 26999532Tompkins 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 40354181Cottrell ML, Prince HMA, Schauer AP, Sykes C, Maffuid K, Poliseno A, Chun TW, Huiting E, Stanczyk FZ, Peery AF, Dellon ES, Adams JL, Gay C, Kashuba ADM. Decreased Tenofovir Diphosphate Concentrations in a Transgender Female Cohort: Implications for Human Immunodeficiency Virus Preexposure Prophylaxis. Clin Infect Dis. 2019 Nov 27;69(12):2201-2204. doi: 10.1093/cid/ciz290.
PubMed 30963179
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sex Hormone Therapy Decrease Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Active Metabolite Formation in Mucosal Tissues?
- ClinicalTrials.gov ID
- NCT02983110
- Acronym / sponsor ID
- SHAMT / 16-2122
- Conditions
- Hiv
- Keywords
- Hormones, Transgender
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to better understand how sex hormone therapy that is used to treat women for menopausal symptoms, men with low testosterone, or as hormone therapy for transgender women, affects a class of medications called NRTIs (nucleoside reverse transcriptase inhibitors) used to treat and prevent HIV infection. The two most commonly used NRTIs are tenofovir and emtricitabine, which are the components of the drug Truvada and also included in the combination products Atripla, Complera, and Stribild. The medication's ability to work effectively may be altered when someone is also taking sex hormone therapy.
In order to determine this effect, samples will be collected from some parts of the body where HIV makes copies. These samples will be measured for the levels of HIV medication, HIV virus and sex hormones that are present. The samples that will be looked at in this study include blood, cells from the vagina, semen, and tissue biopsies from the female genital tract and rectum.
Detailed description
Study Design:
This is an observational study of tenofovir/emtricitabine (TFV/FTC) concentrations in the genital and lower gastrointestinal tracts. Participants will be selected on the basis of receiving TFV/FTC as part of their ongoing HIV care. After participant education, informed consent, and screening for study eligibility, participants will be evaluated at baseline. All samples will be collected over the course of an outpatient sampling visit.
Study Sampling:
- A blood sample will be collected to measure the concentration of TFV/FTC in the blood plasma, the concentration of TFV/FTC active metabolite concentrations (TFVdp/FTCtp) in the PBMCs, and the concentration of sex hormones in the blood stream.
- Vaginal and cervical tissue will be collected (for cisgender women) to measure for concentrations of TFVdp/FTCtp, HIV RNA, and estrogen/progesterone.
- Rectal tissue samples will be collected to measure for concentrations of TFVdp/FTCtp, HIV RNA, estrogen/progesterone (for cisgender and transgender women), and testosterone (for cisgender men).
- A semen sample will be collected (for cisgender men) to measure the concentrations of TFV/FTC, HIV RNA and testosterone.
Pharmacokinetic Analysis:
All blood, cervical, vaginal, semen and rectal tissue samples will be analyzed by the Clinical Pharmacology and Analytical Chemistry Laboratory (CPAC) at the UNC School of Pharmacy. TFV/FTC will be measured in blood and seminal plasma and TFVdp/FTCtp will be measured in PBMCs, SMCs using validated LC-MS/MS methods. HIV RNA will be measured in blood and seminal plasma using the Abbott Real Time HIV-1 quantitative assay. HIV RNA within the cervical and seminal cells and rectal tissues will be measured using an established Droplet Digital PCR method. Estradiol and progesterone will be measured in serum using validated florescent immunoassays.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort B | – | Procedure: Anoscopy with Rectal Tissue Sampling, Procedure: Phlebotomy, Procedure: Female Genital Tract SamplingGroup B will be HIV Infected post-menopausal women who are not receiving hormonal therapy to provide tissue, blood, and cells |
| Cohort C | – | Procedure: Anoscopy with Rectal Tissue Sampling, Procedure: PhlebotomyGroup C will be HIV infected transgendered women receiving hormone therapy to provide tissue and blood |
| Cohort E | – | Procedure: Anoscopy with Rectal Tissue Sampling, Procedure: PhlebotomyGroup E will be HIV infected men |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will consist of 20 HIV positive men and women between 18-65 years of age (inclusive) with an intact gastrointestinal tract, uterus/cervix (if cisgender women), and male genital tract (if cisgender man) who are available to complete all study procedures at UNC.
Key inclusion criteria (15 listed)
- -
- All subjects eligible to enroll must meet the following inclusion criteria, regardless of cohort:
- HIV-positive adults aged 18-65, inclusive on the date of screening, clinically healthy, with an intact gastrointestinal tract. Any screening test may be repeated once in the screening window to confirm or verify eligibility.
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all the pertinent details of the study.
- Willing and able to comply with scheduled visits, treatment plan laboratory tests, and other trial procedures
Key exclusion criteria (9 listed)
- Age outside of desired range
- Subject is HIV negative
- Impaired renal function, as documented with a creatinine clearance <60mL/min with the Cockcroft-Gault equation
- Receiving an antiretorivral regimen that does not include TDF/FTC, or adherent to a TDF/FTC regimen less than one month, or patient is unlikely to remain on this regimen during the sampling period
- Less than 80% adherence to anti-retroviral medications, and more than 3 missed doses in the month preceding enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anoscopy with Rectal Tissue SamplingAll subjects will provide 10 pieces of rectal tissue | Procedure or surgery | Cohort B, Cohort C, Cohort E |
| Phlebotomy• Procedure: Blood plasma/serum collection Approximately 17 mL of blood will be taken from each subject just prior to tissue sampling. | Procedure or surgery | Cohort B, Cohort C, Cohort E |
| Female Genital Tract SamplingCohorts B only will have cervical cells, cervical tissue, and vaginal tissue collected | Procedure or surgery | Cohort B |
Primary outcome
Quantification of tenofovir/emtricitabine active metabolite (TFVdp/FTCtp) concentrations in ectocervical/vaginal (cisgender women) and rectal (all cohorts) tissue biopsies by LC-MS/MS.
Time frame: Samples collected within 24 hours post-dose
(TFVdp/FTCtp)
Quantification of tenofovir/emtricitabine active metabolite (TFVdp/FTCtp) concentrations in PBMCs (all cohorts) and seminal mononuclear cells (cisgender men).
Time frame: Samples collected within 24 hours post-dose
PBMC concentrations
2 secondary outcomes
Quantification of HIV RNA concentrations
Time frame: Samples collected within 24 hours post-dose
Quantification of estradiol/progesterone (cisgender and transgender women) and testosterone (cisgender men) concentrations in blood serum.
Time frame: Samples collected within 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Background: PubMed 26917574Cottrell ML, Yang KH, Prince HM, Sykes C, White N, Malone S, Dellon ES, Madanick RD, Shaheen NJ, Hudgens MG, Wulff J, Patterson KB, Nelson JA, Kashuba AD. A Translational Pharmacology Approach to Predicting Outcomes of Preexposure Prophylaxis Against HIV in Men and Women Using Tenofovir Disoproxil Fumarate With or Without Emtricitabine. J Infect Dis. 2016 Jul 1;214(1):55-64. doi: 10.1093/infdis/jiw077. Epub 2016 Feb 24.
- Background: PubMed 24343710Nicol MR, Fedoriw Y, Mathews M, Prince HM, Patterson KB, Geller E, Mollan K, Mathews S, Kroetz DL, Kashuba AD. Expression of six drug transporters in vaginal, cervical, and colorectal tissues: Implications for drug disposition in HIV prevention. J Clin Pharmacol. 2014 May;54(5):574-83. doi: 10.1002/jcph.248. Epub 2014 Jan 2.
- Background: PubMed 26999532Cottrell ML, Prince HM, Allmon A, Mollan KR, Hudgens MG, Sykes C, White N, Malone S, Dellon ES, Madanick RD, Shaheen NJ, Patterson KB, Kashuba AD. Cervicovaginal and Rectal Fluid as a Surrogate Marker of Antiretroviral Tissue Concentration: Implications for Clinical Trial Design. J Acquir Immune Defic Syndr. 2016 Aug 15;72(5):498-506. doi: 10.1097/QAI.0000000000000996.
- 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.
- Derived from this study: PubMed 30963179Cottrell ML, Prince HMA, Schauer AP, Sykes C, Maffuid K, Poliseno A, Chun TW, Huiting E, Stanczyk FZ, Peery AF, Dellon ES, Adams JL, Gay C, Kashuba ADM. Decreased Tenofovir Diphosphate Concentrations in a Transgender Female Cohort: Implications for Human Immunodeficiency Virus Preexposure Prophylaxis. Clin Infect Dis. 2019 Nov 27;69(12):2201-2204. doi: 10.1093/cid/ciz290.
- 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.
Mackenzie Cottrell, PharmD principal investigator
UNC 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 Hiv, 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 15 inclusion and 9 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 6 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantification of tenofovir/emtricitabine active metabolite (TFVdp/FTCtp) concentrations in ectocervical/vaginal (cisgender women) and rectal (all cohorts) tissue biopsies by LC-MS/MS. (time frame: Samples collected within 24 hours post-dose). The study lists 2 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 NCT02983110, 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 6 Dec 2018.