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Evaluation of 28-week Antiretroviral Treatment with Albuvirtide and Cabotegravir in HIV Patients with Stable Virologic Suppression: Efficacy, Pharmacokinetics, and Safety

Study on the efficacy, pharmacokinetics, and safety of a combination antiretroviral regimen of Albuvirtide administered every 4 weeks with Cabotegravir over 28 weeks of continuous treatment in HIV-infected patients with stable virologic suppression.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089435
Enrollment
Unknown
Registered
2024-09-09
Start date
2024-09-06
Completion date
Unknown
Last updated
2025-05-05

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

Conditions

HIV/AIDS

Interventions

research group:Albuvirtide combined with Categlusevir

Sponsors

Guangzhou Eighth Peoples Hospital Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. aged between 18 and 65; 2. no gender limitation; 3. HIV antibody positive ; 4. Has been on a stable and continuous antiretroviral therapy regimen (excluding ABT) for more than 6 months, and any previous regimen or medication changes were not due to virologic failure; 5.The plasma HIV-1 RNA measurement must be less than 50 copies/mL within the 12 months prior to screening. If the measurement date is within 6 months before the screening period, the previous plasma HIV-1 RNA measurement must also be less than 50 copies/mL; 6. HIV-1 RNA<50 copies/mL in the screening test; 7. Understands and signs the informed consent form prior to any study-related procedures and agrees to comply with study requirements.

Exclusion criteria

Exclusion criteria: 1. patients allergic to CAB , ABT or the relative ingredient; 2. women who are pregnant, lactating or planning to have children; 3. patients with clinical evidence of opportunistic infection and with HIV stage III according to US CDC standard (patients with CD4+T cell count =5×ULN or ALT >=3×ULN with total bilirubin >=1.5×ULN detected during the screening period; 13. Patients with confirmed severe heart disease: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia, or a personal or known family history of prolonged QT syndrome; 14. patients with tattoos or other skin diseases in the thigh area which might affect the determination of the injection sites; 15. patients with treatment of radiotherapy, cytotoxic chemotherapy drugs or any systemic immunosuppressant within 28 days; 16. patients with any unsuitable circumstances for this clinical trial according for the researcher's judgement.

Design outcomes

Primary

MeasureTime frame
the ratio of failed viral supression;

Secondary

MeasureTime frame
immune cell changes;

Countries

China

Contacts

Public ContactLi Linghua

Guangzhou Eighth Peoples Hospital Guangzhou Medical University

llhelia@126.com+86 20 83710825

Outcome results

None listed

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