HIV PreventionNCT04531943
Feminizing Hormone Therapy and the Rectal Mucosa Immune Environment in Transgender Women
An observational study of HIV Prevention, run by Emory University at 1 site in United States.
Trial summary
The overarching goal of this research study is to achieve a better understanding of the rectal mucosal effects of feminizing hormones in people assigned male sex at birth and currently taking feminizing hormones who have sex with men. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Estrogen and Estrogen plus Progesterone
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 4 Apr 2024
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 520 HIV-negative TGWSM and cisgender MSM will be enrolled into one of two cohorts.
Who may be able to join
- Cohort 1, TGWSM using feminizing hormone therapy
- Assigned male sex at birth and currently using feminizing hormone therapy
- Aged 18-59 years
- Able to provide informed consent in the official language of the study site's country
- HIV negative
- Taking feminizing hormone therapy for at least the last 6 months with no change in dose for the last 3 months (i.e. no increase or decrease)
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- Feminizing hormone therapy is defined as use of oral, patch, topical, or injection estrogen therapy with or without progesterone therapy in people who were assigned male sex at birth but take feminizing hormones to affirm their current gender identity
- Approximately half of the cohort to be using estrogen therapy alone and half using estrogen+progesterone
- Anti-androgen therapy is permissive, but dose must also be stable for the last 3 months at the time of enrollment
- Willing to undergo peripheral blood and rectal biopsy sampling
- Willing to abstain from receptive anal intercourse for 72 hours before and for 1 week after rectal biopsy procedure
- Willing to answer sexual behavior questions
- Cohort 1, Cisgender Males
- Assigned male sex at birth, currently identify as male gender (i.e. cisgender), man who has sex with men aged 18-59 years
- Able to provide informed consent in the official language of the study site's country
- HIV negative
- Receptive anal intercourse with a person assigned male sex at birth at least once in lifetime
- No history of taking supplemental steroids including testosterone replacement therapy in the last 12 months
- Willing to undergo peripheral blood and rectal biopsy sampling
- Willing to abstain from receptive anal intercourse for 72 hours before and for 1 week after rectal biopsy procedure.
- Willing to answer sexual behavior questions.
- Cohort 2, Longitudinal study with TGWSM planning to initiate feminizing hormone therapy
- Assigned male sex at birth with plans to start feminizing hormone therapy
- Aged 18-59 years
- Able to provide informed consent in the official language of the study site's country
- Naïve to feminizing hormone therapy or no use in the last 6 months, including anti-androgen therapy.
- HIV negative
- Plans to initiate feminizing hormone therapy in next 6 months.
- Feminizing hormone therapy is defined as use of oral, patch, topical, or injection estrogen therapy with or without progesterone therapy in people who were assigned male sex at birth but take feminizing hormones to affirm their current gender identity.
- Anti-androgen therapy is permissive, but participants must also be initiating estrogen therapy to be eligible.
- Willing to undergo peripheral blood and rectal biopsy sampling
- Willing to abstain from receptive anal intercourse for 72 hours before and for 1 week after rectal biopsy procedure.
- Willing to answer sexual behavior questions.
Who cannot join
- History of inflammatory bowel disease or other inflammatory, infiltrative, infectious or vascular condition involving the lower gastrointestinal tract that, in the judgment of the investigators, may be worsened by study procedures or may significantly distort the anatomy of the distal large bowel
- Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to:
- Hemoglobin (Hgb) ≤ 10 g/dL
- Partial thromboplastin time (PTT) > 1.5x upper limit of normal (ULN) or international normalised ratio (INR) > 1.5x ULN
- Platelet count <100,000
- Any known medical condition that, in the judgment of the investigators, increases the risk of local or systemic complications of endoscopic procedures or pelvic examination, including but not limited to:
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- Uncontrolled or severe cardiac arrhythmia
- Recent major abdominal, cardiothoracic, or neurological surgery in the last 12 months
- History of uncontrolled bleeding diathesis
- History of colonic, rectal, or vaginal perforation, fistula, or malignancy
- History or evidence on clinical examination of ulcerative, suppurative, or proliferative lesions of the anorectal mucosa.
- Use of systemic (oral/IV) antibiotics within the 4 weeks prior to rectal mucosal sampling.
- Participants may be screened/enrolled who do not meet this criterion, but rectal mucosal sampling will be deferred for at least 4 weeks from last systemic antibiotic use.
- Continued need for, or use during the 14 days prior to enrollment, of the following medications:
- Aspirin or more than 4 doses of nonsteroidal anti-inflammatory drugs (NSAIDs)
- Warfarin, heparin (low-molecular weight or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents
- Any form of rectally administered agent besides products (lubricants or douching) used for sexual intercourse
- Continued need for, or use during the 90 days prior to enrollment, of the following medications:
- Systemic immunomodulatory agents
- Supraphysiologic doses of steroids with the exception of short course steroids <7 days duration at the discretion of the investigator and feminizing hormone therapy as detailed in inclusion criteria
- Experimental medications, vaccines, or biologicals
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
The overarching goal of this research study is to achieve a better understanding of the rectal mucosal effects of feminizing hormones in people assigned male sex at birth and currently taking feminizing hormones who have sex with men. Better understanding the rectal mucosa in this population will allow for the optimization of current biomedical HIV prevention interventions and enhance design of future interventions, including an effective HIV vaccine. This study will recruit approximately 520 transgender women who have receptive anal intercourse with men (TGWSM) and cis-gender men into one of two cohorts. Cohort 1 is a cross-sectional study and Cohort 2 is a longitudinal study; enrollment into each cohort is based on participant characteristics.
Read the detailed description
Transgender women who have receptive anal intercourse with men (TGWSM; assigned male sex at birth and taking/planning to take feminizing hormone therapy) are at high risk of HIV, and many HIV infections occur due to exposure to the rectal mucosa. In this study, the researchers will examine the biologic effects of feminizing hormone therapy on the mucosal immune milieu of the rectum. A better understanding of rectal HIV transmission among TGWSM will lead to the development of improved biomedical prevention interventions.
Historically, TGWSM have been grouped with men who have sex with men (MSM) in HIV prevention studies due to presumed similar risks of rectal HIV exposure despite their unique psychosocial, biologic, and prevention needs. From a biologic perspective, many TGWSM use feminizing hormone therapy with uncertain rectal mucosal effects. The effects of endogenous and exogenous hormones in the human and animal-model female genital tract has been described with estrogen generally being seen as hindering HIV transmission and progesterone facilitating transmission; however, few studies report effects on the rectal mucosa. In addition, the intestinal mucosa is known to be steroidogenic, and colonic epithelial cells express estrogen receptor β, suggesting that exogenous hormone therapy likely has an effect on the rectal mucosa that could influence HIV transmission. For this project, the researchers will build upon our successful translational mucosal immunology program with a highly successful clinical research and retention infrastructure that was designed to understand factors that may influence rectal HIV transmission and propose to examine the effects of feminizing hormone therapy on the rectal mucosal resident cellular populations, transcriptome, and microbiome in TGWSM. In the rectal mucosa, the researchers will compare HIV target cell availability, the transcriptome, and microbiome in a cross-sectional cohort of 1) TGWSM on using feminizing hormone therapy (n=300) and 2) cisgender MSM (n=150). The researchers will also examine HIV target cell availability, the transcriptome, and microbiome in a longitudinal study of TGWSM (n=70) before and after initiating feminizing hormone therapy.
Two cohorts of HIV-negative TGWSM will be enrolled in this study. Cohort 1 will be a cross-sectional study where the researchers will enroll 300 TGWSM who are on feminizing hormone therapy and a control group of 150 sexually active cisgender men (assigned male sex at birth and currently identify as male) who have sex with men. Individuals in Cohort 1 will participate in study activities for up to 12 weeks. Cohort 2 is a longitudinal study where 70 TGWSM who are naïve to feminizing hormone therapy or have not taken feminizing hormone therapy for > 6 months and plan to initiate feminizing hormone therapy will be enrolled. Individuals in Cohort 2 will participate in study activities for 18 months.
- Conditions
- HIV Prevention
- Being tested
- Estrogen, Estrogen plus Progesterone
- Keywords
- Transgender women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogenDrug
Feminizing hormone therapy consisting of estrogen alone, as prescribed by the participant's healthcare provider.
Estrogen plus ProgesteroneDrug
Feminizing hormone therapy consisting of estrogen and progesterone, as prescribed by the participant's healthcare provider.
| Study group | Role | What they receive |
|---|---|---|
| TGWSM Using Estrogen | Cohort 1 participants are in the cross-sectional study and will attend two study visits, participating in study activities for up to 12 weeks. Blood samples and rectal mucosal samples will be obtained. This group of participants in Cohort 1 consists of TGWSM currently using feminizing hormone therapy consisting of only estrogen. Receives: Drug: Estrogen | |
| TGWSM Using Estrogen plus Progesterone | Cohort 1 participants are in the cross-sectional study and will attend two study visits, participating in study activities for up to 12 weeks. Blood samples and rectal mucosal samples will be obtained. This group of participants in Cohort 1 consists of TGWSM currently using feminizing hormone therapy consisting of estrogen and progesterone. Receives: Drug: Estrogen plus Progesterone | |
| Cisgender MSM | Cohort 1 participants are in the cross-sectional study and will attend two study visits, participating in study activities for up to 12 weeks. Blood samples and rectal mucosal samples will be obtained. This group of participants in Cohort 1 consists of cisgender MSM. | |
| TGWSM Initiating Feminizing Hormone Therapy | Cohort 2 participants are in the longitudinal portion of the study and are TGWSM who are planning to initiate feminizing hormone therapy. Individuals in Cohort 2 will participate in study activities for 18 months. Receives: Drug: Estrogen; Drug: Estrogen plus Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Rectal Mucosal Cluster of Differentiation 4 (CD4+) T Cells Expressing C-C Chemokine Receptor Type 5 (CCR5) in Cohort 1
The median percentage of rectal mucosal CD4+ T cells that express CCR5 will be compared between groups in Cohort 1.
Measured: Day 1 (day of rectal mucosal sampling)
Change in Percent of Rectal Mucosal CD4+ T cells expressing CCR5 in Cohort 2
The median percentage of rectal mucosal CD4+ T cells that express CCR5 will be compared in Cohort 2, before hormone therapy begins and after hormone therapy.
Measured: Baseline and up to 12 months after initiation of feminizing hormone therapy
Production of p24 from Rectal Mucosal Explant Challenge in Cohort 1
The median production of p24 from rectal mucosal explant challenge experiments as measured by the area under the curve will be compared between groups in Cohort 1.
Measured: Day 1 (day of rectal mucosal sampling)
Change in Production of p24 from Rectal Mucosal Explant Challenge in Cohort 2
The median production of p24 from rectal mucosal explant challenge experiments as measured by the area under the curve will be compared in Cohort 2, before hormone therapy begins and after hormone therapy.
Measured: Baseline and up to 12 months after initiation of feminizing hormone therapy
Relative abundance of Prevotellaceae in Cohort 1
The median relative abundance of Prevotellaceae measured from rectal mucosal secretions will be compared between groups in Cohort 1.
Measured: Day 1 (day of rectal mucosal sampling)
Change in Relative abundance of Prevotellaceae in Cohort 2
The median relative abundance of Prevotellaceae measured from rectal mucosal secretions will be compared in Cohort 2, before hormone therapy begins and after hormone therapy.
Measured: Baseline and up to 12 months after initiation of feminizing hormone therapy
Relative abundance of Bacteroidaceae in Cohort 1
The median relative abundance of Bacteroidaceae measured from rectal mucosal secretions will be compared between groups in Cohort 1.
Measured: Day 1 (day of rectal mucosal sampling)
Change in Relative abundance of Bacteroidaceae in Cohort 2
The median relative abundance of Bacteroidaceae measured from rectal mucosal secretions will be compared in Cohort 2, before hormone therapy begins and after hormone therapy.
Measured: Baseline and up to 12 months after initiation of feminizing hormone therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Oct 2020
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Other
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Kelley, Emory University
- Investigators
- Colleen Kelley, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531943
- Sponsor's protocol ID
- IRB00112414
- Other IDs
- R01AI147839, R21AI157911
- Status last verified
- Jun 2024
- First submitted
- 26 Aug 2020
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results published for this study (including text, tables, figures, and appendices), will be made available for sharing, after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feminizing Hormone Therapy and the Rectal Mucosa Immune Environment in Transgender Women
- ClinicalTrials.gov ID
- NCT04531943
- Acronym / sponsor ID
- IRB00112414
- Conditions
- HIV Prevention
- Keywords
- Transgender women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 31 Aug 2020 (actual)
- 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 overarching goal of this research study is to achieve a better understanding of the rectal mucosal effects of feminizing hormones in people assigned male sex at birth and currently taking feminizing hormones who have sex with men. Better understanding the rectal mucosa in this population will allow for the optimization of current biomedical HIV prevention interventions and enhance design of future interventions, including an effective HIV vaccine. This study will recruit approximately 520 transgender women who have receptive anal intercourse with men (TGWSM) and cis-gender men into one of two cohorts. Cohort 1 is a cross-sectional study and Cohort 2 is a longitudinal study; enrollment into each cohort is based on participant characteristics.
Detailed description
Transgender women who have receptive anal intercourse with men (TGWSM; assigned male sex at birth and taking/planning to take feminizing hormone therapy) are at high risk of HIV, and many HIV infections occur due to exposure to the rectal mucosa. In this study, the researchers will examine the biologic effects of feminizing hormone therapy on the mucosal immune milieu of the rectum. A better understanding of rectal HIV transmission among TGWSM will lead to the development of improved biomedical prevention interventions.
Historically, TGWSM have been grouped with men who have sex with men (MSM) in HIV prevention studies due to presumed similar risks of rectal HIV exposure despite their unique psychosocial, biologic, and prevention needs. From a biologic perspective, many TGWSM use feminizing hormone therapy with uncertain rectal mucosal effects. The effects of endogenous and exogenous hormones in the human and animal-model female genital tract has been described with estrogen generally being seen as hindering HIV transmission and progesterone facilitating transmission; however, few studies report effects on the rectal mucosa. In addition, the intestinal mucosa is known to be steroidogenic, and colonic epithelial cells express estrogen receptor β, suggesting that exogenous hormone therapy likely has an effect on the rectal mucosa that could influence HIV transmission. For this project, the researchers will build upon our successful translational mucosal immunology program with a highly successful clinical research and retention infrastructure that was designed to understand factors that may influence rectal HIV transmission and propose to examine the effects of feminizing hormone therapy on the rectal mucosal resident cellular populations, transcriptome, and microbiome in TGWSM. In the rectal mucosa, the researchers will compare HIV target cell availability, the transcriptome, and microbiome in a cross-sectional cohort of 1) TGWSM on using feminizing hormone therapy (n=300) and 2) cisgender MSM (n=150). The researchers will also examine HIV target cell availability, the transcriptome, and microbiome in a longitudinal study of TGWSM (n=70) before and after initiating feminizing hormone therapy.
Two cohorts of HIV-negative TGWSM will be enrolled in this study. Cohort 1 will be a cross-sectional study where the researchers will enroll 300 TGWSM who are on feminizing hormone therapy and a control group of 150 sexually active cisgender men (assigned male sex at birth and currently identify as male) who have sex with men. Individuals in Cohort 1 will participate in study activities for up to 12 weeks. Cohort 2 is a longitudinal study where 70 TGWSM who are naïve to feminizing hormone therapy or have not taken feminizing hormone therapy for > 6 months and plan to initiate feminizing hormone therapy will be enrolled. Individuals in Cohort 2 will participate in study activities for 18 months.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TGWSM Using Estrogen | – | Drug: EstrogenCohort 1 participants are in the cross-sectional study and will attend two study visits, participating in study activities for up to 12 weeks. Blood samples and rectal mucosal samples will be obtained. This group of participants in Cohort 1 consists of TGWSM currently using feminizing hormone therapy consisting of only estrogen. |
| TGWSM Using Estrogen plus Progesterone | – | Drug: Estrogen plus ProgesteroneCohort 1 participants are in the cross-sectional study and will attend two study visits, participating in study activities for up to 12 weeks. Blood samples and rectal mucosal samples will be obtained. This group of participants in Cohort 1 consists of TGWSM currently using feminizing hormone therapy consisting of estrogen and progesterone. |
| Cisgender MSM | – | –Cohort 1 participants are in the cross-sectional study and will attend two study visits, participating in study activities for up to 12 weeks. Blood samples and rectal mucosal samples will be obtained. This group of participants in Cohort 1 consists of cisgender MSM. |
| TGWSM Initiating Feminizing Hormone Therapy | – | Drug: Estrogen, Drug: Estrogen plus ProgesteroneCohort 2 participants are in the longitudinal portion of the study and are TGWSM who are planning to initiate feminizing hormone therapy. Individuals in Cohort 2 will participate in study activities for 18 months. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 520 HIV-negative TGWSM and cisgender MSM will be enrolled into one of two cohorts.
Key inclusion criteria (33 listed)
- Cohort 1, TGWSM using feminizing hormone therapy
- Assigned male sex at birth and currently using feminizing hormone therapy
- Aged 18-59 years
- Able to provide informed consent in the official language of the study site's country
- HIV negative
Key exclusion criteria (22 listed)
- History of inflammatory bowel disease or other inflammatory, infiltrative, infectious or vascular condition involving the lower gastrointestinal tract that, in the judgment of the investigators, may be worsened by study procedures or may significantly distort the anatomy of the distal large bowel
- Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to:
- Any known medical condition that, in the judgment of the investigators, increases the risk of local or systemic complications of endoscopic procedures or pelvic examination, including but not limited to:
- Use of systemic (oral/IV) antibiotics within the 4 weeks prior to rectal mucosal sampling.
- Continued need for, or use during the 14 days prior to enrollment, of the following medications:
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 |
|---|---|---|
| EstrogenFeminizing hormone therapy consisting of estrogen alone, as prescribed by the participant's healthcare provider. | Drug | TGWSM Initiating Feminizing Hormone Therapy, TGWSM Using Estrogen |
| Estrogen plus ProgesteroneFeminizing hormone therapy consisting of estrogen and progesterone, as prescribed by the participant's healthcare provider. | Drug | TGWSM Initiating Feminizing Hormone Therapy, TGWSM Using Estrogen plus Progesterone |
Primary outcome
Percent of Rectal Mucosal Cluster of Differentiation 4 (CD4+) T Cells Expressing C-C Chemokine Receptor Type 5 (CCR5) in Cohort 1
Time frame: Day 1 (day of rectal mucosal sampling)
The median percentage of rectal mucosal CD4+ T cells that express CCR5 will be compared between groups in Cohort 1.
Change in Percent of Rectal Mucosal CD4+ T cells expressing CCR5 in Cohort 2
Time frame: Baseline and up to 12 months after initiation of feminizing hormone therapy
The median percentage of rectal mucosal CD4+ T cells that express CCR5 will be compared in Cohort 2, before hormone therapy begins and after hormone therapy.
Production of p24 from Rectal Mucosal Explant Challenge in Cohort 1
Time frame: Day 1 (day of rectal mucosal sampling)
The median production of p24 from rectal mucosal explant challenge experiments as measured by the area under the curve will be compared between groups in Cohort 1.
Change in Production of p24 from Rectal Mucosal Explant Challenge in Cohort 2
Time frame: Baseline and up to 12 months after initiation of feminizing hormone therapy
The median production of p24 from rectal mucosal explant challenge experiments as measured by the area under the curve will be compared in Cohort 2, before hormone therapy begins and after hormone therapy.
Relative abundance of Prevotellaceae in Cohort 1
Time frame: Day 1 (day of rectal mucosal sampling)
The median relative abundance of Prevotellaceae measured from rectal mucosal secretions will be compared between groups in Cohort 1.
Change in Relative abundance of Prevotellaceae in Cohort 2
Time frame: Baseline and up to 12 months after initiation of feminizing hormone therapy
The median relative abundance of Prevotellaceae measured from rectal mucosal secretions will be compared in Cohort 2, before hormone therapy begins and after hormone therapy.
Relative abundance of Bacteroidaceae in Cohort 1
Time frame: Day 1 (day of rectal mucosal sampling)
The median relative abundance of Bacteroidaceae measured from rectal mucosal secretions will be compared between groups in Cohort 1.
Change in Relative abundance of Bacteroidaceae in Cohort 2
Time frame: Baseline and up to 12 months after initiation of feminizing hormone therapy
The median relative abundance of Bacteroidaceae measured from rectal mucosal secretions will be compared in Cohort 2, before hormone therapy begins and after hormone therapy.
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 17 Jun 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results published for this study (including text, tables, figures, and appendices), will be made available for sharing, after de-identification.
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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.
Colleen Kelley, MD, MPH principal investigator
Emory University
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 Prevention, run by Emory University 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 33 inclusion and 22 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 17 Jun 2025. 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?
Percent of Rectal Mucosal Cluster of Differentiation 4 (CD4+) T Cells Expressing C-C Chemokine Receptor Type 5 (CCR5) in Cohort 1 (time frame: Day 1 (day of rectal mucosal sampling)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2025.