PACTR202004507940963Other未知
Immunogenetic Modulators of Mucosal Protection from HIV-1
Fred Hutchinson Cancer Research Center University of Washington0 sites812 target enrollmentStarted: March 30, 2020Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Other
- Sponsor
- Enrollment
- 812
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 19 Year(s) to 44 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria
- •The partner (HIV-1 uninfected) participants must meet the following criteria (by self-report, unless otherwise indicated) in order to be eligible for inclusion in the study:
- •Age =18 and =65 and able to provide independent informed consent for research per local regulations and guidelines
- •Able and willing to provide written informed consent to be screened for and to take part in the study
- •Part of a heterosexual couple in which either one or both partners meet the study eligibility criteria for partner (HIV-1 uninfected) participants. Couples are defined by the following criteria:
- •oPartners are sexually active (defined as having had vaginal intercourse with the enrolled partner at least 6 times in the last three months)
- •oPartners plan to remain in the relationship for the duration of the study period.
- •oHIV-1 uninfected status is based on negative HIV-1 rapid tests, at study screening and at the enrollment visit (separate HIV-1 serological testing at both visits must be performed if enrollment is more than 2 weeks after screening)
- •oAble and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures
Exclusion Criteria
- •Potential partner (HIV-1 uninfected) participants who meet any of the following criteria (by self-report, unless otherwise indicated) will be excluded from the study:
- •Self-reported use of antiretroviral pre-exposure prophylaxis (PrEP) use prior to enrollment
- •Active and serious infections, including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy; active clinically significant medical problems including cardiac disease (e.g., symptoms of ischemia, congestive heart failure or arrhythmia), pulmonary disease (steroid dependent chronic obstructive pulmonary disease), diabetes requiring hypoglycemic medication; and previously diagnosed malignancy expected to require further treatment.
Investigators
Similar Trials
Completed
Not Applicable
Immunogenetic Modulators of Mucosal Protection From HIV-1HSV-2 InfectionHIV InfectionsNCT03701802University of Washington812
Completed
Not Applicable
Role of mucosal-protective agents, rebamipide and polaprezinc, in post-gastric endoscopic submucosal dissection ulcer healing, a randomized controlled studysuperficial gastrointestinal neoplasmsJPRN-UMIN000006233Hiraka general hospital150
Recruiting
Not Applicable
Confocal endomicroscopy and leaky gut in Crohn's disease and ulcerative colitis.Crohn's diseaseInflammatory and Immune System - Other inflammatory or immune system disordersOral and Gastrointestinal - Crohn's diseaseulcerative colitisACTRN12613001248752Bankstown Hospital100
Completed
Not Applicable
Identification of microbiota-specific mucosal immune responses driving primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease (IBD).<br>inflammatory bowel disease with bile duct and/or liver disease1001796910019654NL-OMON42112Erasmus MC, Universitair Medisch Centrum Rotterdam250
Completed
Not Applicable
The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human (IV).InfluenzaJPRN-UMIN000009106ational Institute of Infectious Diseases100