Status:
COMPLETED
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)
Lead Sponsor:
Ortho Biotech Products, L.P.
Conditions:
Anemia
HIV Infections
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 t...
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 \< 1...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT00317902
Start Date
October 1 2002
End Date
May 1 2004
Last Update
May 19 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.