Phase 2
Completed N=30
ABX464 in Fully Controlled HIV Infected Patients Treated With Boosted Protease Inhibitor Treatment
Source: ClinicalTrials.gov NCT02735863 ↗Enrolled (actual)
30
Serious AEs
6.7%
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants With Adverse Events — 5; 15; 7; 4 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
5; 15; 7; 4; 15; 3 | — |
| SECONDARY Time to Viral Rebound |
17.2; 14.4; 14.4 | 0.5352 |
Eligibility 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;
Data sourced from ClinicalTrials.gov (NCT02735863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.