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Study on the safety and efficacy of albuvirtide in HIV patients with hepatic insufficiency

Study on the safety and efficacy of albuvirtide in HIV patients with hepatic insufficiency

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066652
Enrollment
Unknown
Registered
2022-12-13
Start date
2022-02-09
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

HIV

Interventions

Experimental group:TDF/TAF+FTC/3TC+ABT

Sponsors

The Second Hospital of Nanjing
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) =18 years old, gender is not limited; 2) HIV-1 antibody confirmatory test is positive; 3) HIV-1 RNA = 500 copies/mL; 4) 2.5?ULN<ALT<10?ULN or 1.6?ULN<TBIL<5?ULN; 5) Before performing any steps related to this study, subjects should understand and sign the informed consent form and comply with the requirements of this study.

Exclusion criteria

Exclusion criteria: 1) Progressive stage of liver failure; 2) Any liver disease caused by vascular, metabolic, autoimmune or tumor; 3) Severe cardiovascular disease, cancer, acute severe infection, kidney injury, and other diseases that the investigators judged not to be included 4) Subjects who have reported drug resistance to the test drug; 5) Known to be resistant to the study drug or allergic to the active ingredients or any additives of the study drug; 6) Alcohol-dependent or other patients who may affect test compliance; 7) Women who are pregnant, breastfeeding or planning to become pregnant; 8) Participates in clinical trials of other drugs within 30 days before enrollment.

Design outcomes

Primary

MeasureTime frame
Transaminase elevation events;

Secondary

MeasureTime frame
Grade 3-4 Adverse Events;HIV-1 RNA;CD4+ T cells;CD4/CD value;

Countries

China

Contacts

Public ContactHongXia Wei

The Second Hospital of Nanjing

wghongxia@sina.com13851507368

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026