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The primary objective of the trial is:
• to evaluate the change from baseline in plasma viral load with placebo and one of up to 4 dose regimens of RDEA806.
The secondary objectives are:
Efficacy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDEA806 400 mg | Experimental | Placebo or RDEA806 400 mg twice daily (BID) for 7 days and a single morning dose on Day 8. |
|
| RDEA806 600 mg | Experimental | Placebo or RDEA806 600 mg once daily (QD) for 7 days with an additional dose on the morning of Day 8. |
|
| RDEA806 800 mg | Experimental | Placebo or RDEA806 800 mg QD using enteric coated tablets for 7 days with an additional morning dose on Day 8. |
|
| RDEA806 1000 mg | Experimental | Placebo or RDEA806 1000 mg QD using enteric coated tablets for 7 days with an additional dose on the morning of Day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDEA806 400 mg | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HIV plasma viral load | 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be assessed as adverse and HIV related events, clinical laboratory test results(hematology, chemistry, urinalysis), vital signs, 12-lead electrocardiograms (ECGs), and physical examination | 22 days | |
| Pharmacokinetics and Resistance | 22 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vijay Hingorani, MD, PhD | Ardea Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamburg | 20099 | Germany | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20498326 | Derived | Moyle G, Boffito M, Stoehr A, Rieger A, Shen Z, Manhard K, Sheedy B, Hingorani V, Raney A, Nguyen M, Nguyen T, Ong V, Yeh LT, Quart B. Phase 2a randomized controlled trial of short-term activity, safety, and pharmacokinetics of a novel nonnucleoside reverse transcriptase inhibitor, RDEA806, in HIV-1-positive, antiretroviral-naive subjects. Antimicrob Agents Chemother. 2010 Aug;54(8):3170-8. doi: 10.1128/AAC.00268-10. Epub 2010 May 24. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Placebo |
|
| RDEA806 1000 mg | Drug |
|
| RDEA806 600 mg | Drug |
|
| RDEA806 800 mg | Drug |
|
| London |
| SW109NH |
| United Kingdom |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |