AnemiaPhase 4NCT00317902
An Open-Label Study to Evaluate the Effect of Every Other Week PROCRIT� (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients (CHAMPS II)
A Phase 4 study testing Epoetin alfa in people with Anemia and HIV Infections, run by Ortho Biotech Products, L.P..
Trial summary
The objective of this study was to treat anemic (Hemoglobin (Hb) < 12 g/dL) HIV-infected subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of > 13 g/dL and then to assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained with every other week (Q2W) PROCRIT (Epoetin… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia, HIV Infections
- What is being tested?
- Epoetin alfa
- How many people
- 292 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to May 2004
- Phase
- Phase 4
- 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
- Understand and sign written informed consent
- HIV-infected patients (as documented by HIV-RNA values)
- HIV/HCV co-infected patients not receiving treatment
- Hemoglobin < 12 g/dL unrelated to transfusion
- Estimated life expectancy of > 9 months
- Has been maintained on a stable antiretroviral regimen for at least four weeks prior to enrollment into this study.
Who cannot join
- Acute, symptomatic opportunistic infection or other acute AIDS defining illness
- Anemia attributable to factors other than HIV infection (i.e., iron, B12 or folate deficiencies, hemolysis, gastrointestinal bleeding)
- HCV co-infected patients who are anticipated to receive treatment with ribavirin/interferon during the study period. Previous treatment with ribavirin/interferon must have been completed at least 12 weeks prior to study entry
- Ferritin level < 40 ng/mL
- Uncontrolled or severe cardiovascular disease including recent (< 6 months) myocardial infarction, uncontrolled hypertension or congestive heart failure
About this study
Official title: An Open-Label Study to Evaluate The Effect of Every Other Week PROCRIT (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients
The objective of this study was to treat anemic (Hemoglobin (Hb) < 12 g/dL) HIV-infected subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of > 13 g/dL and then to assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained with every other week (Q2W) PROCRIT (Epoetin alfa) dosing.
Read the detailed description
This was a Phase IV, open-label, non-randomized, multi-center study conducted in community based practices, physicians networks, or academic institutions in the US. This study included anemic (Hb < 12 g/dL) HIV-infected subjects and HIV/hepatitis C (HCV) co-infected subjects not receiving HCV treatment on a stable anti-retroviral therapy (ART) regimen for at least 4 weeks prior to enrollment.
Quality of life assessments, laboratory results, and transfusion information were obtained during the study. Laboratory tests, vital signs (blood pressure), and incidence and severity of adverse events were collected and assessed.
The primary objective of this study was to assess if every other week PROCRIT (Epoetin alfa) dosing can maintain quality of life in anemic HIV-infected patients. The primary hypothesis of interest was that the mean quality of life score (as measured by MOS-HIV General Health Perception score) at the end of the every other week (Q2W) maintenance phase was not lower than that at the beginning of the maintenance phase by more than 7 points.
It was anticipated that less frequent dosing, every other week, was more convenient for patients and will improve patient compliance. The starting dose (Baseline/Study Day 1) of PROCRIT (Epoetin alfa) for all eligible subjects was 40,000 U given subcutaneously QW. The maximum duration was 24 weeks. Subjects who achieved target Hb levels >= 13 g/dL were converted to a maintenance dose of PROCRIT (Epoetin alfa) sc Q2W.
- Conditions
- Anemia, HIV Infections
- Being tested
- Epoetin alfa
- Keywords
- Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, 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.
The primary objective of this study was to assess if every other week PROCRIT (Epoetin alfa) dosing can maintain quality of life (QOL) in anemic HIV-infected patients between Week 24 (or the last measurement) and the beginning of the maintenance phase
Secondary outcomes (1)
The effect of every other week PROCRIT (Epoetin alfa) dosing on maintaining target hemoglobin levels (>13 g/dL), transfusion utilization and safety in anemic HIV-infected patients measured from the beginning of the maintenance phase to Week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startOct 2002
- Study completionMay 2004
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 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho Biotech Products, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ortho Biotech Products, L.P. Clinical Trial, Study director, Ortho Biotech Products, L.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317902
- Sponsor's protocol ID
- CR005131
- Status last verified
- Apr 2010
- First submitted
- 21 Apr 2006
- Last updated
- 19 May 2011
- Results posted
- No
Publications
Levine AM, Salvato P, Leitz GJ; Champs 2 Study Group. Efficacy of epoetin alfa administered every 2 weeks to maintain hemoglobin and quality of life in anemic HIV-infected patients. AIDS Res Hum Retroviruses. 2008 Feb;24(2):131-9. doi: 10.1089/aid.2006.0200.
PubMed 18284320
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate The Effect of Every Other Week PROCRIT (Epoetin Alfa) Dosing (40,000-60,000 Units) On Maintaining Quality of Life and Target Hemoglobin Levels in Anemic HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00317902
- Acronym / sponsor ID
- CR005131
- Conditions
- Anemia, HIV Infections
- Keywords
- Anemia, erythropoetin, Epoetin alfa, erythropoetin recombinant, HIV, AIDS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Ortho Biotech Products, L.P.Industry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- May 2004 (actual)
- First posted
- 25 Apr 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.
The objective of this study was to treat anemic (Hemoglobin (Hb) < 12 g/dL) HIV-infected subjects with once weekly (QW) PROCRIT (Epoetin alfa) to a target Hb of > 13 g/dL and then to assess if the target Hb level and improvements in Quality of Life (QOL) could be maintained with every other week (Q2W) PROCRIT (Epoetin alfa) dosing.
Detailed description
This was a Phase IV, open-label, non-randomized, multi-center study conducted in community based practices, physicians networks, or academic institutions in the US. This study included anemic (Hb < 12 g/dL) HIV-infected subjects and HIV/hepatitis C (HCV) co-infected subjects not receiving HCV treatment on a stable anti-retroviral therapy (ART) regimen for at least 4 weeks prior to enrollment.
Quality of life assessments, laboratory results, and transfusion information were obtained during the study. Laboratory tests, vital signs (blood pressure), and incidence and severity of adverse events were collected and assessed.
The primary objective of this study was to assess if every other week PROCRIT (Epoetin alfa) dosing can maintain quality of life in anemic HIV-infected patients. The primary hypothesis of interest was that the mean quality of life score (as measured by MOS-HIV General Health Perception score) at the end of the every other week (Q2W) maintenance phase was not lower than that at the beginning of the maintenance phase by more than 7 points.
It was anticipated that less frequent dosing, every other week, was more convenient for patients and will improve patient compliance. The starting dose (Baseline/Study Day 1) of PROCRIT (Epoetin alfa) for all eligible subjects was 40,000 U given subcutaneously QW. The maximum duration was 24 weeks. Subjects who achieved target Hb levels >= 13 g/dL were converted to a maintenance dose of PROCRIT (Epoetin alfa) sc Q2W.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (6 listed)
- Understand and sign written informed consent
- HIV-infected patients (as documented by HIV-RNA values)
- HIV/HCV co-infected patients not receiving treatment
- Hemoglobin < 12 g/dL unrelated to transfusion
- Estimated life expectancy of > 9 months
Key exclusion criteria (5 listed)
- Acute, symptomatic opportunistic infection or other acute AIDS defining illness
- Anemia attributable to factors other than HIV infection (i.e., iron, B12 or folate deficiencies, hemolysis, gastrointestinal bleeding)
- HCV co-infected patients who are anticipated to receive treatment with ribavirin/interferon during the study period. Previous treatment with ribavirin/interferon must have been completed at least 12 weeks prior to study entry
- Ferritin level < 40 ng/mL
- Uncontrolled or severe cardiovascular disease including recent (< 6 months) myocardial infarction, uncontrolled 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
The primary objective of this study was to assess if every other week PROCRIT (Epoetin alfa) dosing can maintain quality of life (QOL) in anemic HIV-infected patients between Week 24 (or the last measurement) and the beginning of the maintenance phase
1 secondary outcome
The effect of every other week PROCRIT (Epoetin alfa) dosing on maintaining target hemoglobin levels (>13 g/dL), transfusion utilization and safety in anemic HIV-infected patients measured from the beginning of the maintenance phase to Week 24.
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 19 May 2011.
- Derived from this study: PubMed 18284320Levine AM, Salvato P, Leitz GJ; Champs 2 Study Group. Efficacy of epoetin alfa administered every 2 weeks to maintain hemoglobin and quality of life in anemic HIV-infected patients. AIDS Res Hum Retroviruses. 2008 Feb;24(2):131-9. doi: 10.1089/aid.2006.0200.
- An Open-Labeled Study to Evaluate The Effect of Every Other Week PROCRIT (Epoetin alfa) Dosing on Maintaining Quality of Life and Target Hemoglobin Levels 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.
Ortho Biotech Products, L.P. Clinical Trial study director
Ortho Biotech Products, L.P.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epoetin alfa in people with Anemia and HIV Infections, run by Ortho Biotech Products, L.P..
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 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: finished, as of the sponsor's last update on 19 May 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The primary objective of this study was to assess if every other week PROCRIT (Epoetin alfa) dosing can maintain quality of life (QOL) in anemic HIV-infected patients between Week 24 (or the last measurement) and the beginning of the maintenance phase. 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 NCT00317902, 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 19 May 2011.