HIV InfectionsHVTN 914NCT02630082
Feasibility of Measuring Immune Resp, Activation in Foreskin/Mucosa in HIV-, Uncircumcised High-HIV-risk MSM, Lima Peru
A study testing Circumcision and Flexible sigmoidoscopy in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
Rectal and genital sampling in HIV prevention trials permits assessments at the site of HIV entry. Yet the safety and acceptability of circumcision and sigmoidoscopy (and associated abstinence recommendations) are unknown in uncircumcised men who have sex with men (MSM) at high risk of HIV infection. Read more about this study
- Who is it for?
- Ages 21 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome, Lentivirus Infections
- What is being tested?
- Circumcision and Flexible sigmoidoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Mar 2013
- Phase
- Interventional
- 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 21 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male, age 21 to 30 years, who, in the 6 months prior to screening, experienced 1 or both of the following HIV risk criteria:
- unprotected anal intercourse with 1 or more male or MTF transgender partner(s); or
- anal intercourse with 2 or more male or MTF transgender partners. Note: Volunteers who have been in a monogamous relationship with an HIV-seronegative partner for > 6 months are excluded.
- Ability and willingness to provide informed consent
- Assessment of understanding: volunteer demonstrates understanding of the procedures and purpose of this study. Participants will complete a questionnaire prior to enrollment with verbal demonstration of understanding of all questionnaire items answered incorrectly.
- Willingness to receive HIV test results
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- Willingness to discuss HIV infection risks (including sexual behavior and drug use) and amenable to HIV risk reduction counseling
- Willingness to undergo phlebotomy, rectal swab, sigmoidoscopy, and circumcision
- Willingness to adhere to safety protocols before and after sigmoidoscopy and circumcision
- Agrees not to enroll in another study of an investigational research agent prior to completion of the last required protocol clinic visit
- Hemoglobin ≥ 13.0 g/dL
- White blood cell (WBC) count = 3300 to 12,000 cells/mm3
- Total lymphocyte count ≥ 800 cells/mm3
- Remaining differential either within institutional normal range or with site physician approval
- Platelets = 125,000 to 550,000/mm3
- Prothrombin time (PT) or partial thromboplastin time (PTT) ≤ 1.25 institutional upper limit of normal; International Normalized Ratio (INR) ≤ 1.5
- Negative HIV-1 and -2 blood test: May use locally available assays that have been approved by HVTN Laboratory Operations.
Who cannot join
- Volunteers who, in the six months prior to screening, have had sexual partners known to be HIV-infected
- Volunteers who, for the 6 months prior to screening, have been in a monogamous relationship with an HIV-seronegative partner
- History of immunodeficiency
- Foreskin covering less than half the glans
- Absolute medical indication for circumcision (balanitis or phimosis)
- Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions). [This exclusion also applies to therapeutic anticoagulation that results in a prolonged PT/INR or PTT.]
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- HIV vaccine(s) received in a prior HIV vaccine trial. For potential participants who received control/placebo in an HIV vaccine trial, the HVTN 914 PSRT will determine eligibility on a case-by-case basis
- Untreated clinical signs or symptoms of genitourinary or colonic infection
- Any medical condition contraindicating circumcision or flexible sigmoidoscopy with biopsies
- History of transactional sex (ie, exchange of sex for money, shelter, food, or drugs) in the preceding 6 months
- Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety, or a participant's ability to give informed consent
- History of keloid scarring
About this study
Official title: A Cohort Study in Lima, Peru to Evaluate Feasibility of Measuring Immune Responses & Activation Levels in the Foreskin & Rectosigmoid Mucosa in HIV-negative, Uncircumcised Men Who Have Sex With Men & Who Are at High Risk for HIV Acquisition
Rectal and genital sampling in HIV prevention trials permits assessments at the site of HIV entry. Yet the safety and acceptability of circumcision and sigmoidoscopy (and associated abstinence recommendations) are unknown in uncircumcised men who have sex with men (MSM) at high risk of HIV infection. The purpose of this study is to evaluate the feasibility of methods for assessing baseline characteristics of the mucosa of MSM at risk of HIV infection in Lima, Peru.
Read the detailed description
The worldwide HIV/AIDS epidemic may only be controlled through development and utilization of a safe and effective vaccine that will prevent HIV infection. To fill gaps in the understanding of HIV vaccines, studies of mucosal immunity aim to complement assessments of systemic immunity. Yet it is unclear, and important to understand, how mucosal collections and the kinetics of immune activation they might initiate may impact peripheral blood endpoints in HIV vaccine trials. The HIV Vaccine Trials Network (HVTN) and the National Institute of Allergy and Infectious Diseases (NIAID) are conducting a single-site, exploratory cohort study evaluating the feasibility of sampling mucosa and assessing cellular immune responses in sexually active men who have sex with men, a population in which later-phase HIV vaccine clinical trials are often conducted.
The primary purpose of HVTN 914 is to assess the feasibility of performing safe and tolerable circumcision and rectosigmoid biopsy studies on a study population of 30 healthy, HIV-seronegative, uncircumcised men in Lima, Peru, aged 21 to 30 years, who have sex with men and who are at high risk for acquisition of HIV; to assess institutional capacities to process mucosal samples; and to identify methods of evaluating foreskin and rectosigmoid mucosal immune responses that provide minimal variability for analysis of small sample sizes.
The study is designed to mimic an HIV vaccine study mucosal collection protocol. Participants agree to elective sigmoidoscopy biopsy collections and circumcision, and actively participate in this study for approximately 7 months. The primary analysis will focus on pre- and post-procedure retention, safety laboratory values, sexual satisfaction, HIV risk behaviors, and levels of activation markers associated with vulnerability to HIV infection in samples of peripheral blood mononuclear cells. A total of 11 study visits (including a screening visit) occur at Weeks 0-5, 10, and 26-28. Study procedures include physical exams, blood and urine collection, HIV testing, and questionnaire. Elective rectosigmoid bioscopy is performed at Weeks 2 and 27. Elective circumcision is performed at Week 4. Some blood collected from participants will be stored and used in future research. Risk-reduction counseling will be conducted at all study visits.
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome, Lentivirus Infections, Retroviridae Infections, RNA Virus Infections, Virus Diseases
- Being tested
- Circumcision, Flexible sigmoidoscopy
- Keywords
- HIV Preventive Vaccine, HIV Seronegativity, Immune Response, Mucosal
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Lentivirus Infections, Retroviridae Infections, RNA Virus Infections, Virus Diseases, Sexually Transmitted Diseases, Viral, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircumcisionProcedure or surgery
Flexible sigmoidoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Circumcision and flexible sigmoidoscopy Receives: Procedure: Circumcision; Procedure: Flexible sigmoidoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre- and post-procedure retention
Number of enrolled trial participants that underwent each procedure visit and attended each follow-up visit
Measured: 28 weeks
White blood cell counts
White blood cells per mm^3
Measured: 28 weeks
Hematocrit
Hematocrit values measured as percentage
Measured: 28 weeks
Hemoglobin
Hemoglobin g/dL
Measured: 28 weeks
Sexual satisfaction
Sexual satisfaction during receptive, insertive sex, and abstinence periods using a CASI behavioral questionnaire (5 point Likert Scale)
Measured: 28 weeks
HIV risk behaviors
Sex without a condom according to a CASI behavioral questionnaire (Yes, No)
Measured: 28 weeks
Levels of activation markers associated with vulnerability to HIV infection
Levels of CCR5, ki67+ Bcl2low, and integrin alpha4beta7 expression on CD4+ CD3+ T cells collected in blood
Measured: 28 weeks
Procedure-related events
Number of procedure related events such as adverse drug reactions, hermorrage/hematoma, infection, pain, perforation/anatomic injury, and edema assessed for severity (NIH/NIAID DIvision of AIDS table for Grading of Severity of Adult and Pediatric Adverse Experiences).
Measured: 28 weeks
Number of operational protocol deviations per mucosal sample
Number of deviations per mucosal sample
Measured: through study completion, an average of 7 months
Proportion of mucosal samples that are evaluable
Percent of total samples (%)
Measured: through study completion, an average of 7 months
Inter-person variability in mucosal responses
Median and range of variables in peripheral blood mononuclear cells, foreskin, and rectosigmoid mucosa
Measured: 28 weeks
Intra-person differences in mucosal responses obtained from the rectosigmoid colon
Median and range of variables in peripheral blood mononuclear cells, foreskin, and rectosigmoid mucosa
Measured: 28 weeks
Number of clinical protocol deviations per mucosal sample
Number of deviations per mucosal sample
Measured: through study completion, an average of 7 months
Number of laboratory protocol deviations per mucosal sample
Number of deviations per mucosal sample
Measured: through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startApr 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630082
- Sponsor's protocol ID
- 11704
- Acronym
- HVTN 914
- Status last verified
- Dec 2015
- First submitted
- 24 Aug 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lama JR, Karuna ST, Grant SP, Swann EM, Ganoza C, Segura P, Montano SM, Lacherre M, De Rosa SC, Buchbinder S, Sanchez J, McElrath MJ, Lemos MP; HVTN 914 Study Team. Transient Peripheral Immune Activation follows Elective Sigmoidoscopy or Circumcision in a Cohort Study of MSM at Risk of HIV Infection. PLoS One. 2016 Aug 18;11(8):e0160487. doi: 10.1371/journal.pone.0160487. eCollection 2016.
PubMed 27536938
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study in Lima, Peru to Evaluate Feasibility of Measuring Immune Responses & Activation Levels in the Foreskin & Rectosigmoid Mucosa in HIV-negative, Uncircumcised Men Who Have Sex With Men & Who Are at High Risk for HIV Acquisition
- ClinicalTrials.gov ID
- NCT02630082
- Acronym / sponsor ID
- HVTN 914 / 11704
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome, Lentivirus Infections, Retroviridae Infections, RNA Virus Infections, Virus Diseases
- Keywords
- HIV Preventive Vaccine, HIV Seronegativity, Immune Response, Mucosal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Dec 2015 (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.
Rectal and genital sampling in HIV prevention trials permits assessments at the site of HIV entry. Yet the safety and acceptability of circumcision and sigmoidoscopy (and associated abstinence recommendations) are unknown in uncircumcised men who have sex with men (MSM) at high risk of HIV infection. The purpose of this study is to evaluate the feasibility of methods for assessing baseline characteristics of the mucosa of MSM at risk of HIV infection in Lima, Peru.
Detailed description
The worldwide HIV/AIDS epidemic may only be controlled through development and utilization of a safe and effective vaccine that will prevent HIV infection. To fill gaps in the understanding of HIV vaccines, studies of mucosal immunity aim to complement assessments of systemic immunity. Yet it is unclear, and important to understand, how mucosal collections and the kinetics of immune activation they might initiate may impact peripheral blood endpoints in HIV vaccine trials. The HIV Vaccine Trials Network (HVTN) and the National Institute of Allergy and Infectious Diseases (NIAID) are conducting a single-site, exploratory cohort study evaluating the feasibility of sampling mucosa and assessing cellular immune responses in sexually active men who have sex with men, a population in which later-phase HIV vaccine clinical trials are often conducted.
The primary purpose of HVTN 914 is to assess the feasibility of performing safe and tolerable circumcision and rectosigmoid biopsy studies on a study population of 30 healthy, HIV-seronegative, uncircumcised men in Lima, Peru, aged 21 to 30 years, who have sex with men and who are at high risk for acquisition of HIV; to assess institutional capacities to process mucosal samples; and to identify methods of evaluating foreskin and rectosigmoid mucosal immune responses that provide minimal variability for analysis of small sample sizes.
The study is designed to mimic an HIV vaccine study mucosal collection protocol. Participants agree to elective sigmoidoscopy biopsy collections and circumcision, and actively participate in this study for approximately 7 months. The primary analysis will focus on pre- and post-procedure retention, safety laboratory values, sexual satisfaction, HIV risk behaviors, and levels of activation markers associated with vulnerability to HIV infection in samples of peripheral blood mononuclear cells. A total of 11 study visits (including a screening visit) occur at Weeks 0-5, 10, and 26-28. Study procedures include physical exams, blood and urine collection, HIV testing, and questionnaire. Elective rectosigmoid bioscopy is performed at Weeks 2 and 27. Elective circumcision is performed at Week 4. Some blood collected from participants will be stored and used in future research. Risk-reduction counseling will be conducted at all study visits.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Procedure: Circumcision, Procedure: Flexible sigmoidoscopyCircumcision and flexible sigmoidoscopy |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Male, age 21 to 30 years, who, in the 6 months prior to screening, experienced 1 or both of the following HIV risk criteria:
- Ability and willingness to provide informed consent
- Assessment of understanding: volunteer demonstrates understanding of the procedures and purpose of this study. Participants will complete a questionnaire prior to enrollment with verbal demonstration of understanding of all questionnaire items answered incorrectly.
- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks (including sexual behavior and drug use) and amenable to HIV risk reduction counseling
Key exclusion criteria (12 listed)
- Volunteers who, in the six months prior to screening, have had sexual partners known to be HIV-infected
- Volunteers who, for the 6 months prior to screening, have been in a monogamous relationship with an HIV-seronegative partner
- History of immunodeficiency
- Foreskin covering less than half the glans
- Absolute medical indication for circumcision (balanitis or phimosis)
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 |
|---|---|---|
| Circumcision | Procedure or surgery | Intervention |
| Flexible sigmoidoscopy | Procedure or surgery | Intervention |
Primary outcome
Pre- and post-procedure retention
Time frame: 28 weeks
Number of enrolled trial participants that underwent each procedure visit and attended each follow-up visit
White blood cell counts
Time frame: 28 weeks
White blood cells per mm^3
Hematocrit
Time frame: 28 weeks
Hematocrit values measured as percentage
Hemoglobin
Time frame: 28 weeks
Hemoglobin g/dL
Sexual satisfaction
Time frame: 28 weeks
Sexual satisfaction during receptive, insertive sex, and abstinence periods using a CASI behavioral questionnaire (5 point Likert Scale)
HIV risk behaviors
Time frame: 28 weeks
Sex without a condom according to a CASI behavioral questionnaire (Yes, No)
Levels of activation markers associated with vulnerability to HIV infection
Time frame: 28 weeks
Levels of CCR5, ki67+ Bcl2low, and integrin alpha4beta7 expression on CD4+ CD3+ T cells collected in blood
Procedure-related events
Time frame: 28 weeks
Number of procedure related events such as adverse drug reactions, hermorrage/hematoma, infection, pain, perforation/anatomic injury, and edema assessed for severity (NIH/NIAID DIvision of AIDS table for Grading of Severity of Adult and Pediatric Adverse Experiences).
Number of operational protocol deviations per mucosal sample
Time frame: through study completion, an average of 7 months
Number of deviations per mucosal sample
Proportion of mucosal samples that are evaluable
Time frame: through study completion, an average of 7 months
Percent of total samples (%)
Inter-person variability in mucosal responses
Time frame: 28 weeks
Median and range of variables in peripheral blood mononuclear cells, foreskin, and rectosigmoid mucosa
Intra-person differences in mucosal responses obtained from the rectosigmoid colon
Time frame: 28 weeks
Median and range of variables in peripheral blood mononuclear cells, foreskin, and rectosigmoid mucosa
Number of clinical protocol deviations per mucosal sample
Time frame: through study completion, an average of 7 months
Number of deviations per mucosal sample
Number of laboratory protocol deviations per mucosal sample
Time frame: through study completion, an average of 7 months
Number of deviations per mucosal sample
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 15 Dec 2015.
- Derived from this study: PubMed 27536938Lama JR, Karuna ST, Grant SP, Swann EM, Ganoza C, Segura P, Montano SM, Lacherre M, De Rosa SC, Buchbinder S, Sanchez J, McElrath MJ, Lemos MP; HVTN 914 Study Team. Transient Peripheral Immune Activation follows Elective Sigmoidoscopy or Circumcision in a Cohort Study of MSM at Risk of HIV Infection. PLoS One. 2016 Aug 18;11(8):e0160487. doi: 10.1371/journal.pone.0160487. eCollection 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Circumcision and Flexible sigmoidoscopy in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 17 inclusion and 12 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 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Pre- and post-procedure retention (time frame: 28 weeks). The study lists 14 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 NCT02630082, which also lists 1 linked publication.
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 15 Dec 2015.