A Phase I/II Study of Recombinant Human GM-CSF in Patient... | NCT00002009

Studies
A Phase I/II Study of Recombinant Human GM-CSF in Patients With AIDS Virus Infection and Leukopenia

NCT00002009

Sponsor

Sandoz

Status

Completed

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

HIV Infections
Cytopenias

Interventions

Sargramostim

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
101

Status Module

Record Verification Date

Jun 1988

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

Phase 1

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
Sargramostim	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Patients must have:

Met the CDC criteria for the diagnosis of AIDS.
Total peripheral blood leukocyte count = or < 3000 cells/mm3 measured on at least two occasions separated by a minimum of one week.
Must have or have recovered from one or more opportunistic infection.
Serum antibody to HTLV-III/LAV with or without viremia.
Anticipated survival of at least 6 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

AIDS related complex (ARC).
History of malignancy other than Kaposi's sarcoma (KS).
Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
Currently hospitalized or hospitalized within the last 4 weeks for the treatment of opportunistic infections.
Presence of renal dysfunction.
Other evidence of primary hematologic or infectious disorders unrelated to AIDS virus infection.

Patients with the following are excluded:

AIDS related complex (ARC).
History of malignancy other than Kaposi's sarcoma (KS).
Excessive diarrhea (more than 5 liquid or non-liquid stools per day).
Currently hospitalized or hospitalized within the last 4 weeks for the treatment of an opportunistic infection.
Dementia or altered mental status that would prohibit the giving and understanding of informed consent.

Prior Medication:

Excluded:

Any marrow suppressive medications such as trimethoprim-sulfamethoxazole combination (TMP-PurposeX) or Fansidar.
Excluded within 6 weeks of study entry:
Any investigational drug.

Prior Treatment:

Excluded within 6 weeks of study entry:

Systemic cytotoxic chemotherapy or irradiation.

Risk Behavior:

Excluded within 3 months of study entry:

Regular, excessive use of alcohol, hallucinogens or agents which are addicting.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
UCLA CARE Ctr		Los Angeles	California	90095	United States
Beth Israel Deaconess - West Campus

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

ID	Term
D015658	HIV Infections
D000095542	Cytopenia
D007970	Leukopenia