HIV InfectionsNCT00002042
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
A study testing Epoetin alfa in people with HIV Infections and Cytopenias, run by Ortho Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HIV Infections, Cytopenias
- What is being tested?
- Epoetin alfa
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ortho Pharmaceutical Corp
Raritan, New Jersey, 088690602
About this study
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.
- Conditions
- HIV Infections, Cytopenias
- Being tested
- Epoetin alfa
- Keywords
- Recombinant Proteins, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, AIDS-Related Complex, Zidovudine
- Medical subject headings
- HIV Infections, Cytopenia, Acquired Immunodeficiency Syndrome, Anemia, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin alfaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Ortho Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002042
- Sponsor's protocol ID
- 004F
- Other IDs
- 87-022
- Status last verified
- Dec 1989
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00002042
- Acronym / sponsor ID
- 004F
- Conditions
- HIV Infections, Cytopenias
- Keywords
- Recombinant Proteins, Erythropoietin, Acquired Immunodeficiency Syndrome, Anemia, AIDS-Related Complex, Zidovudine
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Ortho PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin alfa | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epoetin alfa in people with HIV Infections and Cytopenias, run by Ortho Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.