Clinical trial NCT04645693: The Impact of Oral Health in HIV Patients on Antiretroviral Therapy
Official title: The Impact of Oral Health on Metabolism and Persistent Inflammation in HIV Patients on Antiretroviral Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HIV
Periodontal Diseases
Caries
Non-communicable Disease
Xerostomia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2020-11-27
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients living with HIV above the age of 18 will be enrolled in this study.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dental Caries as assessed by DMFS Score
timeFrame: Baseline
measure: Dental Caries as assessed by DMFS Score
timeFrame: 6 months after baseline visit
measure: Dental Caries as assessed by DMFS Score
timeFrame: 12 months after baseline visit
measure: Dental Caries as assessed by DMFS Score
timeFrame: 18 months after baseline visit
measure: Dental Caries as assessed by DMFS Score
timeFrame: 24 months after baseline visit
measure: Dental Caries as assessed by DMFS Score
timeFrame: 30 months after baseline visit
measure: Periodontal disease
timeFrame: Baseline
measure: Periodontal disease
timeFrame: 12 months after baseline visit
measure: Periodontal disease
timeFrame: 24 months after baseline visit
measure: Periodontal disease
timeFrame: 30 months after baseline visit
measure: Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally
timeFrame: Baseline
measure: Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally
timeFrame: 6 months after baseline visit
measure: Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally
timeFrame: 12 months after baseline visit
measure: Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally
timeFrame: 18 months after baseline visit
measure: Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally
timeFrame: 24 months after baseline visit
measure: Oral mucosal lesions coinfection as assessed by the presence or absence of candidiasis, red/white lesions, ulcers and warts intraorally
timeFrame: 30 months after baseline visit
measure: Osteopenia as assessed by DXA scan findings
timeFrame: Baseline
measure: Osteopenia as assessed by DXA scan findings
timeFrame: 24 months after baseline visit
measure: Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)
timeFrame: Baseline
measure: Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)
timeFrame: 12 months after baseline visit
measure: Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)
timeFrame: 24 months after baseline visit
measure: Quality of life as assessed by the Xerostomia Quality of Life Scale (XeQoLS)
timeFrame: 30 months after baseline visit
measure: Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)
timeFrame: Baseline
measure: Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)
timeFrame: 12 months after baseline visit
measure: Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)
timeFrame: 24 months after baseline visit
measure: Quality of life as assessed by the Oral Health Related Quality of Life (OHRQoL)
timeFrame: 30 months after baseline visit
measure: Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool
timeFrame: Baseline
measure: Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool
timeFrame: 12 months after baseline visit
measure: Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool
timeFrame: 24 months after baseline visit
measure: Quality of life as assessed by the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool
timeFrame: 30 months after baseline visit
Secondary outcomes:
measure: Xerostomia as assessed by stimulated saliva secretion rate
timeFrame: Baseline
measure: Xerostomia as assessed by stimulated saliva secretion rate
timeFrame: 6 months after baseline visit
measure: Xerostomia as assessed by stimulated saliva secretion rate
timeFrame: 12 months after baseline visit
measure: Xerostomia as assessed by stimulated saliva secretion rate
timeFrame: 18 months after baseline visit
measure: Xerostomia as assessed by stimulated saliva secretion rate
timeFrame: 24 months after baseline visit
measure: Xerostomia as assessed by stimulated saliva secretion rate
timeFrame: 30 months after baseline visit
measure: Saliva proteins
timeFrame: Baseline
measure: Saliva proteins
timeFrame: 6 months after baseline visit
measure: Saliva proteins
timeFrame: 12 months after baseline visit
measure: Saliva proteins
timeFrame: 18 months after baseline visit
measure: Saliva proteins
timeFrame: 24 months after baseline visit
measure: Saliva proteins
timeFrame: 30 months after baseline visit
measure: Saliva proteins
timeFrame: baseline visit
measure: Saliva proteins
timeFrame: 6 months after baseline visit
measure: Saliva proteins
timeFrame: 12 months after baseline visit
measure: Saliva proteins
timeFrame: 18 months after baseline visit
measure: Saliva proteins
timeFrame: 24 months after baseline visit
measure: Saliva proteins
timeFrame: 30 months after baseline visit
measure: Correlative measures
timeFrame: Baseline through 30 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Dental Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Temitope Omolehinwa, BDS, DScD
role: PRINCIPAL_INVESTIGATOR
References: