ClinicalTrials.gg
CompletedNCT00002303Updated Jun 24, 2005

The Safety and Effectiveness of r-HuEPO in Patients With AIDS or Advanced AIDS-Related Complex (ARC) Who Are Anemic

An interventional study of Epoetin alfa in HIV Infections and Cytopenias, sponsored by Ortho Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Ortho Pharmaceuticals · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies testing Epoetin Alfa in HIV Infections — none open to participants now, none under way, none of them phase 3. Epoetin Alfa · HIV Infections.

No phase
7 of 10
none open now
Registered
1st of 10
by date
Lead sponsor
6 of 10
Ortho Pharmaceuticals

Among the 10 studies testing Epoetin Alfa in HIV Infections, this one is one of 7 with no phase, and was the 1st registered.

HIV Infections

4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.

Browse HIV Infections studies →

Open to participants now

None of the 10 studies testing Epoetin Alfa in HIV Infections is open now. The open studies under HIV Infections, anywhere →

Where they have run

About Epoetin Alfa

Epoetin Alfa: first FDA approval 1989 (EPOGEN/PROCRIT), first EMA approval 1997. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 10 studies testing Epoetin Alfa in HIV Infections as a file.
02

Study summary

To determine the safety and efficacy of erythropoietin administered to patients with AIDS or advanced AIDS related complex ARC and anemia.

03

Conditions studied

  • HIV Infections
  • Cytopenias

Keywords

  • Recombinant Proteins
  • Erythropoietin
  • Acquired Immunodeficiency Syndrome
  • Anemia
  • AIDS-Related Complex
  • Zidovudine
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • History of any primary hematologic disease.
  • disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying disease.
  • AIDS-related dementia.
  • Uncontrolled hypertension (diastolic blood pressure > 100 mmHg).
  • Presence of concomitant iron deficiency.
  • Anemia attributable to factors other than AIDS or zidovudine (AZT) therapy.
  • Acute opportunistic infection.
  • History of seizures.

Concurrent Medication:

Excluded:

  • Zidovudine (AZT) during the double-blind phase of the study.

Patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying AIDS are excluded.

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) and during double-blind phase of study.

Clinical diagnosis of AIDS related anemia.

  • Clinical diagnosis of AIDS or advanced AIDS related complex (ARC).
  • Clinically stable for 1 month preceding study entry.

Substance abuse.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Masking
Double

Interventions

06

Study locations

1 site
  • Ortho Pharmaceutical Corp
    Raritan, New Jersey 088690602, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002303
Lead sponsor
Ortho Pharmaceuticals
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 1989. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Epoetin Alfa

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