A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia
Official Title ^ICMJE	A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up To Determine the Safety and Efficacy of r-HuEPO in AIDS and Advanced ARC Patients With Anemia
Brief Summary	To determine the safety and efficacy of r-HuEPO administration to patients with AIDS or advanced AIDS related complex (ARC) and anemia secondary to their disease.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind
Condition ^ICMJE	HIV Infections Cytopenias
Intervention ^ICMJE	Drug: Epoetin alfa
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Exclusion Criteria Co-existing Condition: Patients with the following are excluded: History of any primary hematologic disease. HIV disease related dementia. Uncontrolled hypertension (diastolic blood pressure > 100 mmHg). Presence of concomitant iron deficiency. Anemia attributable to factors other than HIV disease or zidovudine (AZT) therapy. Acute opportunistic infection. History of seizures. Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease. Concurrent Medication: Excluded: Zidovudine (AZT) therapy during the double-blind phase of study. Patients with the following are excluded: History of any primary hematologic disease. Clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying HIV disease. HIV disease related dementia. Uncontrolled hypertension (diastolic blood pressure > 100 mmHg). Presence of concomitant iron deficiency. Prior Medication: Excluded within 30 days of study entry: Experimental drug or experimental device. Cytotoxic chemotherapy. Excluded within 2 months of study entry: Androgen therapy. Zidovudine (AZT) therapy and during the double-blind phase. Clinical diagnosis with AIDS or AIDS related complex (ARC) and related anemia. Clinical diagnosis of AIDS or ARC. Clinically stable for 1 month preceding study entry. Patients should preferably be transfusion dependent. Substance abuse.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002042
Responsible Party
Study ID Numbers ^ICMJE	004F, 87-022
Study Sponsor ^ICMJE	Ortho Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	December 1989
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP