ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment (NCT02735863) | Clinical Trial Compass
CompletedPhase 2
ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment
Belgium, France30 participantsStarted 2016-05
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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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;