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ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their HIV.
Two types of design are intended in this protocol: dosing every 3 days or dosing every day. The goal is to determine the best dosing regimen to reduce viral load and minimize adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABX464 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABX464 | Drug | 25, 50, 75, 100, 150 mg, i.e. 1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability profile of ABX464 as assessed by the change from baseline in laboratory values, in vital signs and ECG parameters at week 3 and by the number of patients with adverse events. | Number of patients with abnormal blood (hematology and biochemistry) and urinary laboratory values, abnormal vital signs and ECG parameters and the number/proportion of patients reporting any adverse event. | Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration in plasma of ABX464 and metabolite | week 1, week 2 and week 3 |
| tmax | Time to maximum concentration | Week 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAP Research Ltd | Curepipe | Mauritius | ||||
| HIV-NAT, Thai Red Cross AIDS Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28507108 | Derived | Steens JM, Scherrer D, Gineste P, Barrett PN, Khuanchai S, Winai R, Ruxrungtham K, Tazi J, Murphy R, Ehrlich H. Safety, Pharmacokinetics, and Antiviral Activity of a Novel HIV Antiviral, ABX464, in Treatment-Naive HIV-Infected Subjects in a Phase 2 Randomized, Controlled Study. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00545-17. doi: 10.1128/AAC.00545-17. Print 2017 Jul. |
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| ID | Term |
|---|---|
| C000623073 | ABX464 |
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| Placebo | Other | 1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks |
|
| AUC | Area under the concentration-time curve | Week 3 |
| t1/2 | Half-life of the ABX464 in plasma | Week 3 |
| Pharmacodynamic activity as expressed by CD4 and CD8 count | CD4 and CD8 values | Week 3 |
| Pharmacodynamic activity as expressed by HIV viral load | HIV viral load across time and possible relationship with PK parameters | Week 3 |
| Bangkok |
| 10330 |
| Thailand |
| Siriraj Hospital, Mahidol University | Bangkok | 10700 | Thailand |
| Chiang Mai University | Chiang Mai | 50200 | Thailand |