An interventional study of Basic periodontal treatment in HIV/AIDS and Periodontal Diseases, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 36 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-27.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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Among 57 studies in Acquired Immunodeficiency Syndrome with a site in Brazil — 7 open to participants now, 10 under way, 4 of them phase 3. Acquired Immunodeficiency Syndrome · Brazil.
Among the 57 studies in Acquired Immunodeficiency Syndrome with a site in Brazil, this one is the 40th largest by enrollment of the 42 interventional ones that give a count, is one of 4 that started in 2017, is one of 11 with no phase, and was the 35th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →7 of the 57 studies in Acquired Immunodeficiency Syndrome with a site in Brazil are open now. Recruiting first, the newest first:
Federal University of São Paulo · Sites in Brazil
Ages 18–60
Federal University of São Paulo · Sites in Brazil
Ages 18–65
Hospital Alemão Oswaldo Cruz · Sites in Brazil
Ages 18+
Federal University of Health Science of Porto Alegre · Sites in Brazil
Ages 18+
Code Pharma · Sites in Brazil
Ages 18+
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 36 Years and older · all sexes · healthy volunteers too.
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57 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 132 across the 42 interventional studies, 923 across the 14 observational. Of the 40 that completed or were terminated, 16 (40%) have results posted.
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24 of 57 have an industry lead sponsor. The 10 most frequent:
University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
University of Sao Paulo has 2 studies filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
5 of the studies in Acquired Immunodeficiency Syndrome with a site in Brazil that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07044297Phase 3Merck Sharp & Dohme LLCA Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) | 2027-07-22 |
| NCT07118683Hospital Alemão Oswaldo CruzBRAZILIAN REGISTRY OF CHRONIC NON-COMMUNICABLE DISEASES IN PEOPLE LIVING WITH HIV/AIDS | 2026-11 |
| NCT06805656Federal University of São PauloMulti Interventional Approaches to Mitigate HIV Reservoirs for the Sustained HIV Remission Without Antiretrovirals | 2027-03-01 |
| NCT06497504GlaxoSmithKlineStudy of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus) | 2027-04-22 |
| NCT07903441Federal University of São PauloMultiple Interventions With Distinct Anti-reservoir Activities in People on Antiretroviral Treatment | 2027-07-31 |
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Among the 57 studies in Acquired Immunodeficiency Syndrome with a site in Brazil, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Periodontal diseases, such as chronic periodontitis (CP), frequently occur in immunosuppressed patients, including HIV-infected patients. The immunosuppression resulted by the HIV infection can justify the high frequency and the difficult in controlling the CP in this group of patients, raising the possibility of additional factors associated to the development of CP in HIV patients. The aim of this study is to determine factors that can be involved in the CP pathogenesis in HIV patients, including Candida spp presence, and biomarkers involved on the inflammatory response against the microorganisms.
Investigators will develop one quasi-experimental study in HIV patients (N=15) and non-HIV patients (N=15) presenting CP. Candida spp count and salivary and gingival crevicular fluid concentrations of histatin, lactoferrin, interleukin-1β, interleukin-6, and tumor necrosis factor-α will be determined at baseline, 30 and 90 days after the periodontal treatment. In order to minimize the influence of the immunosuppressive condition, patients have to present CD4 T lymphocytes \< 200cel/mm3 blood count, non-detectable viral load and the same protocol of antiretroviral therapy. Additionally, investigators intend to determine the immunophenotypic profile of the gingival tissue through immunohistochemical analysis. This study was approved by the Institutional Review Board of the School of Dentistry of Ribeirão Preto (CAAE: 50004415.1.0000.5419), and all patients need to provide written informed consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.
Procedure: Basic periodontal treatment
Patients will be treated for their chronic periodontitis (basic periodontal treatment) and samples of gingival crevicular fluid and saliva will be collected at baseline, 30 days and 60 days after the periodontal treatment for the study analysis.
Procedure: Basic periodontal treatment
Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.
Also known as: Non-surgical periodontal treatment
Change in clinical signs of chronic periodontitis.
Clinical parameters of the periodontal diseases: Dental biofilm index and bleeding on probing (BOP) measured in percentage associated to pocket probing depth (PPD) and clinical attachment loss (CAL) measured in millimeters will be combined to report the effect of periodontal treatment on the chronic periodontitis in percentage of sites with no periodontal diseases signs.
Time frame: Baseline, 30 days and 90 days.
Change in Candida spp carriage.
Number of Candida spp colonies on culture plates.
Time frame: Baseline, 30 days and 90 days.
Change in salivary biomarkers
Concentrations of histatin, lactoferrin and inflammatory cytokines in saliva and gingival crevicular fluid in pg/mL.
Time frame: Baseline, 30 days and 90 days.
Change in bacterial microbiota
Pyrosequencing characterization of the bacterial microbiota
Time frame: Baseline, 30 days and 90 days.
Plan to share: Yes — Individual participant data of all primary and secondary outcomes will be made available.
Supporting information: Study protocol
Time frame: Data will be available within 3 months of study completion.
Access criteria: Data access criteria will be reviewed by the an external independent review panel.
Ran from Jul 2017 to primary completion in Aug 2018, 13 months.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 13 months is below that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →