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A Study to Assess the Effectiveness of PROCRIT (Epoetin Alfa) Dosing Every 2 Weeks Versus Once a Week in Anemic HIV-infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00246298
Recruitment Status : Terminated (OBI business decision not to complete any additional research in HIV.)
First Posted : October 30, 2005
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
Ortho Biotech Products, L.P.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE October 28, 2005
First Posted Date  ICMJE October 30, 2005
Last Update Posted Date June 10, 2011
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2005)
Change in hemoglobin from baseline to the end of study at Week 12
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2005)
The primary objective is to evaluate if initiating PROCRIT® Q2W dosing is as effective as initiating PROCRIT® QW dosing in increasing Hb levels in anemic (<12.0g/dl) HIV-infected subjects.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2005)
Safety and tolerability of every other week dosing and once a week dosing.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2005)
To assess the safety and tolerability of Q2W dosing and QW dosing.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Effectiveness of PROCRIT (Epoetin Alfa) Dosing Every 2 Weeks Versus Once a Week in Anemic HIV-infected Patients
Official Title  ICMJE 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
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia
  • HIV
Intervention  ICMJE Drug: epoetin alfa
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 25, 2010)
31
Original Enrollment  ICMJE
 (submitted: October 28, 2005)
128
Actual Study Completion Date  ICMJE September 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00246298
Other Study ID Numbers  ICMJE CR003220
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE Ortho Biotech Products, L.P.
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP