Oral Mucosa Transcriptomic Data from Three HIV+cART Patients

Control GroupIn order to be eligible to participate in this study, an individual must meet all of the following criteria:Inclusion criteria:•    Consent and Compliance:Willing to sign consent form and willing, able, and likely to comply with all study procedures and restrictions. Subjects must demonstrate understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent.•    Age:Subjects must be 18 years of age or older, There is no upper limit for age. However, most participants will be between 25 – 65 years of age and will be age matched with HIV+ individuals.•    Diagnosis:In good general health. Participants with oral inflammatory lesions (including gingivitis, periodontitis), oral cancer diagnosis, and soft tissue lesions will be excluded.Exclusion criteria:The presence of any of the following will exclude a subject from study enrollment:•    Any use of tobacco in the past month. Study Coordinator will verify their non tobacco status, based on self-reporting during consent procedure. Salivary Cotinine ELISA will also be used to further verify their non-smoking status or non tobacco status.  •    Presence of oral inflammatory lesions (including gingivitis, periodontitis and soft tissue lesions) in the area of the biopsy. The dentist will verify that, based on visual screening and medical records during the consent procedure.•    People who may be at risk for complications related to the oral biopsy (e.g., bleeding disorder, or other issues). Study Coordinator will get that information, based on self-reporting during the consent procedure.HIV-Positive Study GroupIn order to be eligible to participate in this study, an individual must meet all of the following criteria:Inclusion criteria:•    Consent and Compliance:Willing to sign consent form and willing, able, and likely to comply with all study procedures and restrictions. Subjects must demonstrate understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent. •    Age:Subjects must be 18 years of age or older. There is no upper limit for age. There is no upper limit for age. However, most participants will be between 25 – 65 years of age and will be age matched with control group.•    Diagnosis:HIV positive with cART treatment for at least 1 year. Study coordinator will get this information based on self-reporting during consent procedure. Medical records will be reviewed for further verification.  •    HIV-positive participants in the lesion-positive subgroup must have a white or red lesion in the mouth. Saliva samples will be tested for Candida albicans in a qPCR assay. These lesions may or may not test positive for the presence of candida at the time of recruitment.Exclusion criteria:The presence of any of the following will exclude a subject from study enrollment:•    Any use of tobacco in the past month. Study Coordinator will verify their non tobacco status, based on self-reporting during consent procedure. Salivary Cotinine ELISA will also be used to further verify their non-smoking or non tobacco status. •    People who may be at risk for complications related to the oral biopsy (e.g., bleeding disorder, or other issues). Study Coordinator will get that information, based on self-reporting during the consent procedure.]]>
The study was started in 2017 and the recruitment was completed in 2019. As of 2021, the study is open just for assays on stored samples and data analysis. ]]>