CompletedNot Applicable

The Impact of Oral Health in HIV Patients on Antiretroviral Therapy

United States227 participantsStarted 2021-02-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dental Caries as assessed by DMFS Score

Timeframe: Baseline

Dental Caries as assessed by DMFS Score

Timeframe: 6 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 12 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 18 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 24 months after baseline visit

Periodontal disease

Timeframe: Baseline

Periodontal disease

Timeframe: 12 months after baseline visit

Periodontal disease

Trial details

NCT IDNCT04645693

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-28

View on ClinicalTrials.gov More HIV trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Dental Caries as assessed by DMFS Score

Timeframe: Baseline

Dental Caries as assessed by DMFS Score

Timeframe: 6 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 12 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 18 months after baseline visit

Dental Caries as assessed by DMFS Score

Timeframe: 24 months after baseline visit

Periodontal disease

Timeframe: Baseline

Periodontal disease

Timeframe: 12 months after baseline visit

Periodontal disease