NCT00002042

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 1989

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsCytopenias

Keywords

Recombinant ProteinsErythropoietinAcquired Immunodeficiency SyndromeAnemiaAIDS-Related ComplexZidovudine

Interventions

Epoetin alfaDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ortho Pharmaceutical Corp

Raritan, New Jersey, 088690602, United States

Location

MeSH Terms

Conditions

HIV InfectionsCytopeniaAcquired Immunodeficiency SyndromeAnemiaAIDS-Related Complex

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHematologic DiseasesHemic and Lymphatic DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1989-12

Locations

US(1)