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Changes in microbial translocation among people living with HIV needing terbinafine treatment for onychomycosis: a pilot observational study

Effect of terbinafine on intestinal barrier function in people living with HIV

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043617
Enrollment
Unknown
Registered
2021-02-23
Start date
2021-02-22
Completion date
Unknown
Last updated
2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

onychomycosis

Interventions

Observation group:Oral terbinafine hydrochloride

Sponsors

Chongqing Public Health Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Male or female adults >= 18 years of age. (2) People living with HIV who are on a stable ART regimen (same prescription) for at least 6 months (3) Naive onychomycosis patients who are prescribed oral terbinafine treatment and who have not received any antifungal treatment in the past 3 months.

Exclusion criteria

Exclusion criteria: (1) Included in other clinical studies (except non-interventional studies) in the past 6 months; (2) Serious cardiovascular and cerebrovascular diseases, liver and kidney diseases, diabetes, blood diseases, autoimmune diseases, severe malnutrition. (3) Intestinal diseases: acute and chronic enteritis, ulcerative colitis, Crohn's disease, irritable bowel syndrome; (4) Taken drugs that have significant influence on the intestinal barrier, such as metformin, probiotics and prebiotics, in the past 4 weeks; (5) Received enteroscopy in the last 4 weeks; (6) Known Allergy to terbinafine or equivalent medication; (7) Other factors that may have significant influence on the study.

Design outcomes

Primary

MeasureTime frame
Plasma(1?3)-ß-D-glucan;Plasma intestinal fatty acid binding protein;Plasma 3a regenerating islet-derived protein-3a,;Microbiota composition;mycobiota composition;Plasma Lipopolysaccharide;

Countries

China

Contacts

Public ContactJing Ouyang

Chongqing Public Health Medical Center

ouyangjing820421@126.com+86 15683858730

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026