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The efficacy and safety of a regimen containing albuvirtide (ABT) in the treatment of multidrug-resistant HIV-1 infection: a prospective, single arm study

The efficacy and safety of a regimen containing albuvirtide (ABT) in the treatment of multidrug-resistant HIV-1 infection: a prospective, single arm study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081019
Enrollment
Unknown
Registered
2024-02-20
Start date
2024-02-21
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

AIDS

Interventions

ABT group:12 weeks of ART treatment containing ABT, with a regimen of ABT intravenous infusion, 160mg/dose or 320mg/dose, once a day on days 1, 2, 3, and 8 after initiation of ABT treatment, and once

Sponsors

The First People's Hospital of Yuexi County
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Confirmed as HIV-1 infection through initial screening and supplementary testing; (2) Accepting ART for = 1 year; (3) Before using ABT, the HIV-1 RNA was = 200 copies/mL; (4) Prior to the use of ABT, HIV-1 resistance test results confirmed multiple drug resistance (low or higher resistance to at least two different types of antiviral drugs, but not including resistance to lopinavir/ritonavir (LPV/r)); (5) Willing to accept ABT antiviral treatment and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who have previously used gp41 fusion inhibitor; (2) Female patients who are pregnant, breastfeeding, or planning to conceive during the use of ABT; (3) There are contraindications for the use of ABT and LPV/r (see ABT and LPV/r instructions for details); (4) Unable to receive follow-up within the specified time; (5) Infected individuals with poor compliance.

Design outcomes

Primary

MeasureTime frame
HIV-1 RNA;

Secondary

MeasureTime frame
HIV-1 DNA;HIV-1 genotypic drug resistance;CD4+ T cells;

Countries

China

Contacts

Public ContactBianchuan Cao

The First People's Hospital of Yuexi County

tccbc2016@swmu.edu.cn+86 191 1587 4181

Outcome results

None listed

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