Naïve HIV POC Monotherapy Trial

Study Overview
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Brief Summary
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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 to describe the nadir of the plasma viral load to describe the DAVG to assess the proportion of subjects who reached a drop in viral load of 0.5 log, 1 log, or reach an undetectable viral load to assess the plasma viral load decay rate to evaluate immunologic changes (as measured by CD4 and CD8 cells) to evaluate the genotypic and phenotypic pattern of the virus Pharmacokinetics to evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of RDEA806 Safety to evaluate the safety and tolerability of bid and qd dosing of RDEA806 as monotherapy

Official Title
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A Multicenter Phase 2a, Randomized, Double-blind, Placebo-controlled, Proof-of-concept Trial to Determine the Antiviral Activity, Pharmacokinetics, Tolerability and Safety of RDEA806 in HIV-1 Positive, Antiretroviral naïve Subjects

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: RDEA806 400 mg
* Drug: Placebo
* Drug: RDEA806 1000 mg
* Drug: RDEA806 600 mg
* Drug: RDEA806 800 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented chronic HIV-1 infection HIV-1 plasma viral load at screening visit above 5000 HIV-1 RNA copies/ml Male, aged above 18 years and less than 65 years of age Adequate method of birth control Subject has never received an antiretroviral agent (NRTI, NNRTI, PI, entry inhibitor or integrase inhibitor) for the treatment of HIV and agrees not to start antiretroviral therapy prior to enrollment or subject has only received a short course of treatment for less than 14 days and has been off treatment for at least 8 weeks Subject has no primary mutation in the reverse transcriptase (RT) gene associated with resistance to RT inhibitors and no major mutation in the protease gene associated with resistance to PIs determined by genotypic resistance testing at screening Exclusion Criteria: History or suspicion of alcohol or drug abuse which in the Investigator's opinion may lead to non-compliance CD4 count < 350 cells/mm3 Life expectancy of less than 6 months Receipt of an investigational drug within 30 days prior to the trial drug administration Receipt of any vaccine within 30 days of screening visit Acute HIV-1 infection (seroconversion illness) Acute hepatitis A or acute or chronic hepatitis B or C infection Currently active acquired immune deficiency syndrome (AIDS)-defining illness (Category C conditions according to the Centers for Disease Control [CDC] Classification System for HIV Infection 1993) No clinically relevant laboratory abnormalities Renal impairment: serum creatinine > 1.5 x ULN Febrile illness within 120 hours prior to dosing History of severe drug allergy or hypersensitivity Significant cardiac dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RDEA806 400 mg<br>Placebo or RDEA806 400 mg twice daily (BID) for 7 days and a single morning dose on Day 8. | Drug: RDEA806 400 mg<br> <br> Drug: Placebo<br>* Placebo<br>|
| Experimental: RDEA806 600 mg<br>Placebo or RDEA806 600 mg once daily (QD) for 7 days with an additional dose on the morning of Day 8. | Drug: Placebo<br>* Placebo<br>Drug: RDEA806 600 mg<br> <br> |
| Experimental: RDEA806 800 mg<br>Placebo or RDEA806 800 mg QD using enteric coated tablets for 7 days with an additional morning dose on Day 8. | Drug: Placebo<br>* Placebo<br>Drug: RDEA806 800 mg<br> <br> |
| Experimental: RDEA806 1000 mg<br>Placebo or RDEA806 1000 mg QD using enteric coated tablets for 7 days with an additional dose on the morning of Day 8. | Drug: Placebo<br>* Placebo<br>Drug: RDEA806 1000 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HIV plasma viral load |  | 9 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, treatment naïve