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| Name | Class |
|---|---|
| The HIV Netherlands Australia Thailand Research Collaboration | OTHER |
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The purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced dose Efavirenz arm | Experimental | Patient's on main study that was randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd). |
|
| Normal Efavirenz dose arm | Active Comparator | Patient's on main study randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efavirenz | Drug | 400mg qd; 2 x 200mg |
| |
| Efavirenz |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the comparison between of neurocognitive function in patients initiating sdEFV and 400EFV | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The association between week 4 plasma EFV levels and change from baseline neurocognitive function to week 4 and 24. | Week 24 | |
| To assess dynamic changes in neurocognitive function over the total duration of follow-up. | 96 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebekah Puls | Kirby Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIVNAT Research Collaboration | Bangkok | Thailand |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
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| Drug |
600mg qd; 3 x 200mg qd |
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