The Impact of Oral Health in HIV Patients on Antiretroviral Therapy (OHART)

University of Pennsylvania

Status: Active, not recruiting

Conditions: Xerostomia; Non-communicable Disease; HIV; Periodontal Diseases; Caries

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04645693

843328

R01DE029648-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

350 participants in 2 patient groups

HIV Subjects with Non-Communicable Diseases

Description:

Patients living with HIV on Antiretroviral Therapy drugs for at least one year with no diagnosis of non-communicable diseases (diabetes, insulin resistance, hyperlipidemia/dyslipidemia, vascular disease, and/or osteoporosis).

HIV Subjects without Non-Communicable Diseases

Description:

Patients living with HIV on Antiretroviral Therapy drugs for at least one year with a diagnosis of one or more systemic non-communicable diseases (diabetes, insulin resistance, hyperlipidemia/dyslipidemia, vascular disease, and/or osteoporosis).