NCT02369965

Test Albuvirtide in Experienced Patients

Efficacy and Safety of Albuvirtide for Injection Combined With LPV/r for Treatment of HIV-1-Infected Patients Failed First-line Antiretroviral Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 418 (actual)
• Sponsor: Frontier Biotechnologies Inc. · Industry
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of albuvirtide combined with lopinavir-ritonavir (LPV/r) in HIV-1-infected patients who failed first-line antiretroviral therapy (ART).

Detailed description

This was a 48-week, multi-center, open-label, randomized and controlled, non-inferiority phase 3 clinical trial to evaluate the safety and efficacy of albuvirtide combined with LPV/r in HIV-1 infected patients who failed their first-line ART and had HIV-1 RNA levels ≥ 1000 copies/mL at screening. The trial was conducted in 12 sites in China. Subjects meeting inclusion criteria were randomized in a 1:1 ratio to ABT group and NRTI group, in which the ABT group received albuvirtide and LPV/r combination therapy, and NRTI group received the standard 3-drug regimen of LPV/r + Lamivudine (3TC) + Tenofovir (TDF). If TDF was used in the previous regimen or genotypic resistance histories showed primary mutation to TDF, zidovudine (AZT) or abacavir (ABC) would be used. Albuvirtide was given by weekly intravenous infusion and LPV/r was given twice daily orally. A total of 418 subjects were randomized, of whom 401 received at least one treatment.

Conditions

• HIV Infections
• AIDS

Interventions

Type	Name	Description
DRUG	albuvirtide	albuvirtide 320mg administered intravenously once a week
DRUG	lopinavir-ritonavir	lopinavir-ritonavir 400/100mg administered orally twice daily
DRUG	tenofovir	tenofovir 300mg administered orally once daily
DRUG	lamivudine	lamivudine 300mg administered orally once daily

Timeline

• Start date: 2014-02-19
• Primary completion: 2018-04-02
• Completion: 2018-04-02
• First posted: 2015-02-24
• Last updated: 2021-10-06

Locations

12 sites across 1 country: China