HIV InfectionsPhase 2NCT00393120
Safety/Effectiveness of Oral Chemokine Coreceptor 5 (CCR5) Antagonist INCB009471 in R5-tropic HIV Infected Patients
A Phase 2 study testing INCB009471 in people with HIV Infections, run by Incyte Corporation at 6 sites in United States.
Trial summary
This study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not currently on a HAART regimen and have not received any antiretroviral agents for 3 months prior to the Screening visit. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- INCB009471
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2006to Sep 2007
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asymptomatic HIV-1 infected individuals that are treatmen naïve (ie less than 2 weeks prior ARV exposure) or treatment experienced subjects who are not currently on HAART and have not received any ARVs for 3 months prior to Screening.
- Males between 18 years and 65 years of age, utilizing adequate contraceptive methods.
- Post menopausal or surgically sterile females between 18 years and 65 years of age. Women of childbearing potential, utilizing adequate contraceptive methods.
- CD4-lymphocyte count >350 cells/mm3
- HIV-1 RNA copies/ml > 10,000.
- HIV-1 is CCR5 tropic virus only.
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- CCR5 antagonist treatment naive.
- BMI > 16 to < 32 kg/m2.
- Have no clinically significant findings on screening evaluations, which in the opinion of the Investigator would interfere with the subject's ability to comply with the protocol.
- Able to comprehend and willing to sign an Informed Consent Form.
Who cannot join
- Current or recent (<30 days) opportunistic infection.
- Presence of CXCR4- or dual-tropic HIV-1 virus at Screening or Baseline assessments.
- Subjects with chronic renal insufficiency
- Personal history of cardiac diseases.
- History or presence of an abnormal ECG.
- History of unstable ischemic heart disease or uncontrolled hypertension.
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- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
- Subjects who have received radiation therapy or cytotoxic chemotherapeutic agents and have not recovered from side effects.
- Current treatment or treatment within 30 days or 5 half-lives with another investigational medication or current enrollment in another investigational drug protocol.
- Subjects with unstable medical condition (s), which , in the opinion of the Investigator would compromise their participation in the trial
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Annandale, Virginia, 20037
Study site
Boston, Massachusetts, 02130
Study site
Los Angeles, California, 90069
Study site
Orlando, Florida, 32803
Study site
Vero Beach, Florida, 32960
Study site
Washington D.C., District of Columbia, 20007
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability, PK & Virological Effect of Once Daily Oral Dosing of INCB009471 as Monotherapy for 14 Days in ARV-naïve/Limited ARV-experienced, HIV-1 Infected Pts.
This study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not currently on a HAART regimen and have not received any antiretroviral agents for 3 months prior to the Screening visit. Subjects will receive study medication (INCB009471) admnistered orally or placebo once daily with food for 14 days. Clinical safety laboratories, 12-lead electrocardiograms, physical examinations and virologic assessments, including viral load, viral tropism and CD4+ cell count determinations will be performed at the Screening visit and at regularly scheduled visits throughout the study. A blood sample will also be obtained and stored to potentially determine the genotype of the CCR5 receptor.
The primary objectives are:
- Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days;
- Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days;
- Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days
- Conditions
- HIV Infections
- Being tested
- INCB009471, Placebo comparator
- Keywords
- HIV-infection, viral load, CCR5, viral tropism, HIV-1 infection, Treatment Naive
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCB009471Drug
100mg SR (sustained release) orally once daily
INCB009471Drug
300mg SR (sustained release) orally once daily
Placebo comparatorDrug
Orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment A - INCB009471 100mg IR | Experimental | INCB009471, 100 mg IR orally once daily Receives: Drug: INCB009471 |
| Treatment B - INCB009471 300mg SR | Experimental | INCB009471, 300 mg SR orally once daily Receives: Drug: INCB009471 |
| Treatment C - Placebo | Placebo comparator | Placebo matching INCB009471 Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be assessed by monitoring adverse experiences.
Measured: Baseline, every 1-7 days following the initiation of treatment through Day 28 and then at Day 42 or the early study termination visit.
Secondary outcomes (1)
The virological response to INCB009471 as monotherapy will be assessed by measuring HIV-1 RNA levels by the Roche Amplicor HIV-1 Monitor® Test, v1.5 - Quantitative.
Measured: Baseline, Days 4, 7, 10, 14, 16, 20 and 28 or the early termination study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Levy, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393120
- Sponsor's protocol ID
- INCB 9471-201
- Other IDs
- INCB 9471-201, IND No.69,030
- Status last verified
- Mar 2018
- First submitted
- 24 Oct 2006
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study Exploring the Safety, Tolerability, PK & Virological Effect of Once Daily Oral Dosing of INCB009471 as Monotherapy for 14 Days in ARV-naïve/Limited ARV-experienced, HIV-1 Infected Pts.
- ClinicalTrials.gov ID
- NCT00393120
- Acronym / sponsor ID
- INCB 9471-201
- Conditions
- HIV Infections
- Keywords
- HIV-infection, viral load, CCR5, viral tropism, HIV-1 infection, Treatment Naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 26 Oct 2006 (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.
This study will evaluate the safety, pharmacokinetics and efficacy of the CCR5 antagonist INCB009471 in HIV-1 infected patients who are antiretroviral therapy naïve, or who are not currently on a HAART regimen and have not received any antiretroviral agents for 3 months prior to the Screening visit. Subjects will receive study medication (INCB009471) admnistered orally or placebo once daily with food for 14 days. Clinical safety laboratories, 12-lead electrocardiograms, physical examinations and virologic assessments, including viral load, viral tropism and CD4+ cell count determinations will be performed at the Screening visit and at regularly scheduled visits throughout the study. A blood sample will also be obtained and stored to potentially determine the genotype of the CCR5 receptor.
The primary objectives are:
- Assess the safety and tolerability of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days;
- Determine the pharmacokinetics of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days;
- Evaluate the anti-retroviral activity of 3 doses of INCB009471 or placebo when administered orally, once daily, as monotherapy for 14 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A - INCB009471 100mg IR | Experimental | Drug: INCB009471INCB009471, 100 mg IR orally once daily |
| Treatment B - INCB009471 300mg SR | Experimental | Drug: INCB009471INCB009471, 300 mg SR orally once daily |
| Treatment C - Placebo | Placebo comparator | Drug: Placebo comparatorPlacebo matching INCB009471 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Asymptomatic HIV-1 infected individuals that are treatmen naïve (ie less than 2 weeks prior ARV exposure) or treatment experienced subjects who are not currently on HAART and have not received any ARVs for 3 months prior to Screening.
- Males between 18 years and 65 years of age, utilizing adequate contraceptive methods.
- Post menopausal or surgically sterile females between 18 years and 65 years of age. Women of childbearing potential, utilizing adequate contraceptive methods.
- CD4-lymphocyte count >350 cells/mm3
- HIV-1 RNA copies/ml > 10,000.
Key exclusion criteria (10 listed)
- Current or recent (<30 days) opportunistic infection.
- Presence of CXCR4- or dual-tropic HIV-1 virus at Screening or Baseline assessments.
- Subjects with chronic renal insufficiency
- Personal history of cardiac diseases.
- History or presence of an abnormal ECG.
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 |
|---|---|---|
| INCB009471100mg SR (sustained release) orally once daily | Drug | Treatment A - INCB009471 100mg IR |
| INCB009471300mg SR (sustained release) orally once daily | Drug | Treatment B - INCB009471 300mg SR |
| Placebo comparatorOrally once daily | Drug | Treatment C - Placebo |
Primary outcome
Safety and tolerability will be assessed by monitoring adverse experiences.
Time frame: Baseline, every 1-7 days following the initiation of treatment through Day 28 and then at Day 42 or the early study termination visit.
1 secondary outcome
The virological response to INCB009471 as monotherapy will be assessed by measuring HIV-1 RNA levels by the Roche Amplicor HIV-1 Monitor® Test, v1.5 - Quantitative.
Time frame: Baseline, Days 4, 7, 10, 14, 16, 20 and 28 or the early termination study visit.
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 26 Mar 2018.
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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.
Richard Levy, MD study director
Incyte Corporation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INCB009471 in people with HIV Infections, run by Incyte Corporation at 6 sites in United States.
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 10 inclusion and 10 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 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability will be assessed by monitoring adverse experiences. (time frame: Baseline, every 1-7 days following the initiation of treatment through Day 28 and then at Day 42 or the early study termination visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2018.