HIV InfectionsPhase 2NCT00617526
Naïve HIV POC Monotherapy Trial
A Phase 2 study testing RDEA806 400 mg, RDEA806 1000 mg and RDEA806 600 mg in people with HIV Infections, run by Ardea Biosciences, Inc. at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- RDEA806 400 mg, RDEA806 1000 mg and RDEA806 600 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2008to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read more
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
- Conditions
- HIV Infections
- Being tested
- RDEA806 400 mg, Placebo, RDEA806 1000 mg, RDEA806 600 mg, RDEA806 800 mg
- Keywords
- HIV, treatment naïve
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDEA806 400 mgDrug
PlaceboDrug
Placebo
RDEA806 1000 mgDrug
RDEA806 600 mgDrug
RDEA806 800 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| RDEA806 400 mg | Experimental | Placebo or RDEA806 400 mg twice daily (BID) for 7 days and a single morning dose on Day 8. Receives: Drug: RDEA806 400 mg; Drug: Placebo |
| 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. Receives: Drug: Placebo; Drug: RDEA806 600 mg |
| 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. Receives: Drug: Placebo; Drug: RDEA806 800 mg |
| 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. Receives: Drug: Placebo; Drug: RDEA806 1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HIV plasma viral load
Measured: 9 days
Secondary outcomes (2)
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
Measured: 22 days
Pharmacokinetics and Resistance
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardea Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vijay Hingorani, MD, PhD, Study director, Ardea Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617526
- Sponsor's protocol ID
- RDEA806-201
- Status last verified
- Dec 2013
- First submitted
- 6 Feb 2008
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20498326
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00617526
- Acronym / sponsor ID
- RDEA806-201
- Conditions
- HIV Infections
- Keywords
- HIV, treatment naïve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ardea Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RDEA806 400 mg | Experimental | Drug: RDEA806 400 mg, Drug: PlaceboPlacebo or RDEA806 400 mg twice daily (BID) for 7 days and a single morning dose on Day 8. |
| RDEA806 600 mg | Experimental | Drug: Placebo, Drug: RDEA806 600 mgPlacebo or RDEA806 600 mg once daily (QD) for 7 days with an additional dose on the morning of Day 8. |
| RDEA806 800 mg | Experimental | Drug: Placebo, Drug: RDEA806 800 mgPlacebo or RDEA806 800 mg QD using enteric coated tablets for 7 days with an additional morning dose on Day 8. |
| RDEA806 1000 mg | Experimental | Drug: Placebo, Drug: RDEA806 1000 mgPlacebo or RDEA806 1000 mg QD using enteric coated tablets for 7 days with an additional dose on the morning of Day 8. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDEA806 400 mg | Drug | RDEA806 400 mg |
| PlaceboPlacebo | Drug | RDEA806 1000 mg, RDEA806 400 mg, RDEA806 600 mg, RDEA806 800 mg |
| RDEA806 1000 mg | Drug | RDEA806 1000 mg |
| RDEA806 600 mg | Drug | RDEA806 600 mg |
| RDEA806 800 mg | Drug | RDEA806 800 mg |
Primary outcome
Change from baseline in HIV plasma viral load
Time frame: 9 days
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Derived from this study: PubMed 20498326Moyle 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vijay Hingorani, MD, PhD study director
Ardea Biosciences
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RDEA806 400 mg, RDEA806 1000 mg and RDEA806 600 mg in people with HIV Infections, run by Ardea Biosciences, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HIV plasma viral load (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00617526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.