Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000587
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
1999-10-27
Brief Title:
Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether administration of human recombinant erythropoietin REPO improved or eliminated the anemia seen in human immunodeficiency virus HIV infected patients after therapy with zidovudine ZDV
Detailed Description:
BACKGROUND
Reports had shown that between 24 and 78 percent of patients with Acquired Immune Deficiency Syndrome treated with zidovudine for four to six months developed significant bone marrow toxicity requiring zidovudine dosage alterations blood transfusions or cessation of therapy While zidovudine efficacy had been demonstrated in patients with AIDS or ARC it was also evaluated in patients with AIDS-related illness as well as in asymptomatic HIV-infected individuals The clinically significant zidovudine-induced anemia developing in a substantial number of these patient groups and requiring blood transfusions could cause a significant drain on the blood supply in the United States
The project was part of an Institute-initiated study on the Pathobiology of Bone Marrow Suppression in AIDS or AIDS-Related Complex The concept was approved at the May 1987 National Heart Lung and Blood Advisory Council The Request for Applications was released in December 1987
DESIGN NARRATIVE
Double-blind placebo-controlled Patients received intravenous REPO 1000 IUkg or placebo twice per week The five patients in Group A had no transfusion history The five patients in Group B had a history of transfusions Prior to the study the authors determined that treatment would continue for twelve weeks or until the hemoglobin reached 125 gdl After the twelve week study period patients were eligible to receive open label erythropoietin 500 IUkg twice a week For numerous reasons recruitment of patients was a major problem in this trial The study originally estimated a total of 64 patients
Reports had shown that between 24 and 78 percent of patients with Acquired Immune Deficiency Syndrome treated with zidovudine for four to six months developed significant bone marrow toxicity requiring zidovudine dosage alterations blood transfusions or cessation of therapy While zidovudine efficacy had been demonstrated in patients with AIDS or ARC it was also evaluated in patients with AIDS-related illness as well as in asymptomatic HIV-infected individuals The clinically significant zidovudine-induced anemia developing in a substantial number of these patient groups and requiring blood transfusions could cause a significant drain on the blood supply in the United States
The project was part of an Institute-initiated study on the Pathobiology of Bone Marrow Suppression in AIDS or AIDS-Related Complex The concept was approved at the May 1987 National Heart Lung and Blood Advisory Council The Request for Applications was released in December 1987
DESIGN NARRATIVE
Double-blind placebo-controlled Patients received intravenous REPO 1000 IUkg or placebo twice per week The five patients in Group A had no transfusion history The five patients in Group B had a history of transfusions Prior to the study the authors determined that treatment would continue for twelve weeks or until the hemoglobin reached 125 gdl After the twelve week study period patients were eligible to receive open label erythropoietin 500 IUkg twice a week For numerous reasons recruitment of patients was a major problem in this trial The study originally estimated a total of 64 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None