Treatment Program for Anemia in AIDS Patients | NCT00002022

Studies
Treatment Program for Anemia in AIDS Patients

NCT00002022

Sponsor

R W Johnson Pharmaceutical Research Institute

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

HIV Infections
Cytopenias

Interventions

Epoetin alfa

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
I88-083

Status Module

Record Verification Date

Feb 1991

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 1999

First Submission Date that Met QC Criteria

Aug 30, 2001

First Posted Date

Aug 31, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Epoetin alfa	Drug

Eligibility Module

Eligibility Criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

Life expectancy < 3 months.
= or < grade 4 performance score.
AIDS-related dementia.
Uncontrolled hypertension.
Acute symptomatic opportunistic infection or other AIDS-defining illness.

Patients with the following are excluded:

Life expectancy < 3 months.
= or < grade 4 performance score.
AIDS-related dementia.
Uncontrolled hypertension.
Acute symptomatic opportunistic infection or other AIDS-defining illness.

Patients must have:

A clinical diagnosis of AIDS.
Hematocrit < 30 percent.
Endogenous serum erythropoietin level = or < 500 U/ml.
A life expectancy = or > 3 months.
> Grade 4 performance score.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
R W Johnson Pharmaceutical Research Institute		Raritan	New Jersey	088690602	United States

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D000095542	Cytopenia
D000163	Acquired Immunodeficiency Syndrome
D000740	Anemia

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068817	Epoetin Alfa

Ancestor Terms

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided