AnemiaPhase 2NCT00246298
A Study to Assess the Effectiveness of PROCRIT (Epoetin Alfa) Dosing Every 2 Weeks Versus Once a Week in Anemic HIV-infected Patients
A Phase 2 study testing epoetin alfa in people with Anemia and HIV, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to determine if PROCRIT® (a glycoprotein that stimulates red blood cell production) initiated at once every 2 weeks dosing is as effective as PROCRIT® initiated at once a week dosing, in increasing hemoglobin levels in anemic HIV-infected subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- epoetin alfa
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Sep 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be documented HIV positive and on a stable antiretroviral regimen for at least four weeks prior to enrollment
- have a hemoglobin level <12.0 g/dL
- have not undergone cancer therapy (chemotherapy and/or radiation therapy) within 12 months prior to enrollment
Who cannot join
- History of acute, symptomatic opportunistic infection or other acute AIDS defining illness within six months of enrollment
- History of any primary hematologic disease
- Have anemia attributable to factors other than HIV infection (i.e. iron, or vitamin B12 deficiency, hemolysis, or gastrointestinal bleeding)
- Have Hepatitis C virus (HCV) co-infection
- Have uncontrolled or severe cardiovascular disease including recent myocardial infarction, hypertension, or congestive heart failure
About this study
Official title: A Randomized, Open-Label Study Assessing the Efficacy of Initiating PROCRIT (Epoetin Alfa) Dosing at Q2W vs. PROCRIT Dosing at QW in Anemic HIV-infected Subjects
The purpose of this study is to determine if PROCRIT® (a glycoprotein that stimulates red blood cell production) initiated at once every 2 weeks dosing is as effective as PROCRIT® initiated at once a week dosing, in increasing hemoglobin levels in anemic HIV-infected subjects.
Read the detailed description
In the Highly Active Antiretroviral Treatment (HAART) era, anemia is one of the most common abnormalities in HIV-infected subjects. Epoetin alfa is proven to increase hemoglobin levels and improve quality of life in HIV-infected subjects. Although there are data to show that epoetin alfa dosed weekly significantly increases hemoglobin to a target level of 13 g/dL and every other week dosing can maintain target hemoglobin, there is no data to show that initiation of epoetin alfa every 2 weeks will increase hemoglobin levels significantly.
This randomized, two-arm, open-label study will evaluate if initiating PROCRIT® every other week dosing is as effective as initiating PROCRIT® weekly dosing, in increasing hemoglobin in anemic HIV-infected subjects. The Screening phase will start 2 weeks prior to the first dose of PROCRIT®. HIV-infected subjects who have a hemoglobin level of <12.0 g/dL and are on a stable antiretroviral regimen will be screened for study eligibility. In the treatment phase, subjects will be randomized in a 1:1 ratio to receive 40,000 IU PROCRIT® subcutaneous injections either weekly (QW) or every other week (Q2W). The primary endpoint is the change in hemoglobin from baseline to the end of study at Week 12. The safety and tolerability of PROCRIT® in this subject population will be assessed by evaluating adverse events, laboratory results and vital signs. The total duration of this study is 14 weeks, including a 2-week screening phase and a 12-week treatment phase. The primary hypothesis is that the mean increase in hemoglobin for subjects receiving PROCRIT® every 2 weeks is not lower than those receiving weekly PROCRIT® dosing by more than 1 g/dL. Subjects will initially receive 40,000 IU PROCRIT® subcutaneous injections either weekly (QW) or every other week (Q2W), with subsequent dose adjustments, if appropriate. The maximum length of PROCRIT® treatment for this study is 12 weeks.
- Being tested
- epoetin alfa
- Keywords
- Anemia, erythropoetin, Epoetin alfa, erythropoietin recombinant, HIV infection, HIV, AIDS
- Medical subject headings
- Anemia, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetin alfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin from baseline to the end of study at Week 12
Secondary outcomes (1)
Safety and tolerability of every other week dosing and once a week dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startOct 2005
- Study completionSep 2006
Why it stopped: OBI business decision not to complete any additional research in HIV.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Products, L.P.
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246298
- Sponsor's protocol ID
- CR003220
- Status last verified
- Mar 2010
- First submitted
- 28 Oct 2005
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study Assessing the Efficacy of Initiating PROCRIT (Epoetin Alfa) Dosing at Q2W vs. PROCRIT Dosing at QW in Anemic HIV-infected Subjects
- ClinicalTrials.gov ID
- NCT00246298
- Acronym / sponsor ID
- CR003220
- Keywords
- Anemia, erythropoetin, Epoetin alfa, erythropoietin recombinant, HIV infection, HIV, AIDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: OBI business decision not to complete any additional research in HIV.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Ortho Biotech Products, L.P.
- Study start
- Oct 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 31 Oct 2005 (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 purpose of this study is to determine if PROCRIT® (a glycoprotein that stimulates red blood cell production) initiated at once every 2 weeks dosing is as effective as PROCRIT® initiated at once a week dosing, in increasing hemoglobin levels in anemic HIV-infected subjects.
Detailed description
In the Highly Active Antiretroviral Treatment (HAART) era, anemia is one of the most common abnormalities in HIV-infected subjects. Epoetin alfa is proven to increase hemoglobin levels and improve quality of life in HIV-infected subjects. Although there are data to show that epoetin alfa dosed weekly significantly increases hemoglobin to a target level of 13 g/dL and every other week dosing can maintain target hemoglobin, there is no data to show that initiation of epoetin alfa every 2 weeks will increase hemoglobin levels significantly.
This randomized, two-arm, open-label study will evaluate if initiating PROCRIT® every other week dosing is as effective as initiating PROCRIT® weekly dosing, in increasing hemoglobin in anemic HIV-infected subjects. The Screening phase will start 2 weeks prior to the first dose of PROCRIT®. HIV-infected subjects who have a hemoglobin level of <12.0 g/dL and are on a stable antiretroviral regimen will be screened for study eligibility. In the treatment phase, subjects will be randomized in a 1:1 ratio to receive 40,000 IU PROCRIT® subcutaneous injections either weekly (QW) or every other week (Q2W). The primary endpoint is the change in hemoglobin from baseline to the end of study at Week 12. The safety and tolerability of PROCRIT® in this subject population will be assessed by evaluating adverse events, laboratory results and vital signs. The total duration of this study is 14 weeks, including a 2-week screening phase and a 12-week treatment phase. The primary hypothesis is that the mean increase in hemoglobin for subjects receiving PROCRIT® every 2 weeks is not lower than those receiving weekly PROCRIT® dosing by more than 1 g/dL. Subjects will initially receive 40,000 IU PROCRIT® subcutaneous injections either weekly (QW) or every other week (Q2W), with subsequent dose adjustments, if appropriate. The maximum length of PROCRIT® treatment for this study is 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must be documented HIV positive and on a stable antiretroviral regimen for at least four weeks prior to enrollment
- have a hemoglobin level <12.0 g/dL
- have not undergone cancer therapy (chemotherapy and/or radiation therapy) within 12 months prior to enrollment
Key exclusion criteria (5 listed)
- History of acute, symptomatic opportunistic infection or other acute AIDS defining illness within six months of enrollment
- History of any primary hematologic disease
- Have anemia attributable to factors other than HIV infection (i.e. iron, or vitamin B12 deficiency, hemolysis, or gastrointestinal bleeding)
- Have Hepatitis C virus (HCV) co-infection
- Have uncontrolled or severe cardiovascular disease including recent myocardial infarction, hypertension, or congestive heart failure
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 |
|---|---|---|
| epoetin alfa | Drug | – |
Primary outcome
Change in hemoglobin from baseline to the end of study at Week 12
1 secondary outcome
Safety and tolerability of every other week dosing and once a week dosing.
Results and safety
The study was stopped early (reason given: OBI business decision not to complete any additional research in HIV.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- A Randomized, Open Label Study Assessing the Efficacy of Initiating PROCRIT Dosing at Q2W vs. PROCRIT Dosing at QW in Anemic HIV-infected PatientsLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epoetin alfa in people with Anemia and HIV, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: OBI business decision not to complete any additional research in HIV.). Results are not available in the source record.
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 in hemoglobin from baseline to the end of study at Week 12. 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 10 Jun 2011.