The Impact of Oral Health in HIV Patients on Antiretroviral Therapy

  • STATUS
    Recruiting
  • End date
    Nov 1, 2025
  • participants needed
    350
  • sponsor
    University of Pennsylvania
Updated on 1 May 2021

Summary

This is a prospective cohort study designed to investigate the range of metabolic abnormalities observed in patients living with HIV on antiretroviral therapy. This study will also explore the concurrent role of poor oral health in supporting and driving chronic immune activation and inflammation in HIV infection.

Description

This is a prospective cohort study designed to investigate the range of metabolic abnormalities observed in patients living with HIV (PLWH) on antiretroviral therapy (ART). This study will also explore the concurrent role of poor oral health in supporting and driving chronic immune activation and inflammation in HIV infection.

Following enrollment in study, patients will be followed up every 6 months for approximately 2.5 years (30 months). During this period, comprehensive medical records will be obtained, and study data will be updated every 6 months; questionnaires will be handed to patients periodically to assess quality of life and effects of xerostomia on QoL; social history will be assessed using TAPS; oral health will be evaluated every 6 months and blood, saliva, and oral swabs collected every 6 months. DXA scan and panoramic radiographs will also be taken at baseline and 24 months.

At the end of the study, caries rate, periodontal health, bone loss, QoL, salivary quantity and composition, presence or absence of white/red lesions, as well as inflammatory cytokines and immune activation markers will be assessed.

Details
Condition HIV, HIV positive, HIV infection, Periodontal disease, AIDS Vaccines, Xerostomia, Dental caries, Salivary Gland Disease, Saliva and Salivary Gland Dysfunction, HIV (Pediatric), Dry Mouth, HIV Infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines, cavities, cavity, caries, tooth decay, Non-communicable Disease, Non-communicable Disease
Clinical Study IdentifierNCT04645693
SponsorUniversity of Pennsylvania
Last Modified on1 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
Has been diagnosed with HIV (as documented by a prior laboratory report of positive HIV-1/2 antibody and/or detectable HIV RNA, available for review by the study team)
Has received antiretroviral therapy for at least 12 months
Able and willing to provide informed consent prior to initiation of study procedures
Willing and able to comply with all study procedures, and likely to be available for the duration of the study

Exclusion Criteria

Has been diagnosed with the following xerostomia-related autoimmune conditions: Sjorgen's and sarcoidosis
Has never received radiation therapy to the head or neck (including radioactive iodine therapy)
Was taking anti-osteoporotic agents (biphosphonates, denosumab) prior to HIV diagnosis
Women who are pregnant at the time of enrollment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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