Naïve HIV POC Monotherapy Trial
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|ClinicalTrials.gov Identifier: NCT00617526|
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : January 28, 2014
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:
- 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
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: RDEA806 400 mg Drug: Placebo Drug: RDEA806 1000 mg Drug: RDEA806 600 mg Drug: RDEA806 800 mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||August 2008|
Experimental: RDEA806 400 mg
Placebo or RDEA806 400 mg twice daily (BID) for 7 days and a single morning dose on Day 8.
Drug: RDEA806 400 mg
Experimental: RDEA806 600 mg
Placebo or RDEA806 600 mg once daily (QD) for 7 days with an additional dose on the morning of Day 8.
PlaceboDrug: RDEA806 600 mg
Experimental: RDEA806 800 mg
Placebo or RDEA806 800 mg QD using enteric coated tablets for 7 days with an additional morning dose on Day 8.
PlaceboDrug: RDEA806 800 mg
Experimental: RDEA806 1000 mg
Placebo or RDEA806 1000 mg QD using enteric coated tablets for 7 days with an additional dose on the morning of Day 8.
PlaceboDrug: RDEA806 1000 mg
- Change from baseline in HIV plasma viral load [ Time Frame: 9 days ]
- 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 [ Time Frame: 22 days ]
- Pharmacokinetics and Resistance [ Time Frame: 22 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617526
|Hamburg, Germany, 20099|
|London, United Kingdom, SW109NH|
|Study Director:||Vijay Hingorani, MD, PhD||Ardea Biosciences|