ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a placebo-controlled study aimed at assessing the safety of ABX464 administered at 50 mg and 150 mg o.d. versus placebo in HIV infected patients who are treated with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abivax S.A.
• Treatments: Cobicistat; Darunavir; HIV Protease Inhibitors; Protease Inhibitors; Ritonavir

Criteria

Inclusion Criteria:

• Patients infected with HIV;

• Patients with HIV plasma viral load ≤ 50 copies mL-1 during the 6 months prior to screening with a maximum of 2 blips during this period;

• Patients treated by DRV/RTV or DRV/COBI as a monotherapy for at least 8 weeks prior to baseline;

• Patients' HIV plasma viral load ≤100,000 copies mL-1 at any time (apart from primary infection if recorded);

• Patients' CD4+ T cells count ≥ 250 cells per mm3 at any time since diagnosis;

• Patients with CD4+ T cells count ≥ 600 cells per mm3 at screening;

• Man or woman aged 18-65 years;

Exclusion Criteria:

• Patient displaying any HIV protease inhibitor resistance mutation as listed in the current version of the HIV drug resistance database (Stanford University);

• Patient having had previously a viral load ≥ 500 copies mL-1 confirmed by a second measure since the initiation of the current ART;

• History of an AIDS-defining clinical illness;

• Concomitant AIDS-related opportunistic infection;