HIV Infections Clinical Trial
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.
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.
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Intervention Model: Single Group Assignment, Masking: Open Label
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