Effectiveness and Safety of use ior LeukoCIM as prophylaxis and treatment of Neutropenia in patients with HIV / AIDS.

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Effectiveness and Safety of use ior LeukoCIM as prophylaxis and treatment of Neutropenia in patients with HIV/AIDS.

Secondary indentifying numbers:

IIC RD-EC088

Issuing authority of the secondary identifying numbers:

Center of Molecular Inmunology(CIM)

Source(s) of monetary or material support:

Goverment found

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

12/09/2005

Reference number:

151545

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

MD.Lilia Maria Ortega Gonzalez.Second degree specialist in Internal Medicine.Intensive.Master's degree in Infectious Diseases in Tropical Medicine.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Santiago de Cuba, Juan Bruno Zayas Clinical Surgical Hospital, MD.Ventura Puente Sani.First degree specialist in Internal Medicine.

Research ethics committees:

Pedro Kouri Tropical Medicine Institute (IPK), June 12, 2005. Juan Bruno Zayas Clinical Surgical Hospital, January 18, 2007

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

05/10/2005

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Neutropenia in patients with HIV/AIDS.

Intervention(s):

Starting dose: 5µg/Kg/day. Subcutaneously. Terms of Use: Prophylaxis: The administration is initiated between 24 and 72 hours of completion of chemotherapy (CT) and radiotherapy (RT), with a daily frequency from 5 to 8 consecutive days. If the patient develops neutropenia, the treatment will continue until ANC = 1.5x109/L. Neutropenia secondary to CT cycles and/or RT or associated with viral replication (HIV) or opportunistic infections: The administration begins when neutropenia is diagnosed (ANC <= 1x109 / L), with a daily frequency until ANC = 1.5x109/L. Maximum duration of treatment: 21 days

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Recovery of Absolute Neutrophil count (ANC) numbers = 1.5 x109/L (Yes/No), Measurement time: 5-8 days.

Key secondary outcomes:

Administration of the next cycle of CT at the scheduled time (Yes/No), Measurement time: the end of the treatment. Recovery time of the Absolute Neutrophil Count (ANC), a difference of dates between start and end of treatment (days), measurement time: the end of the treatment. ANC on the fifth day, the numerical value (x109 / L), time of measurement: the 5th day. Biochemical parameters, values as the units for each parameter, Measurement time: the end of the treatment. Occurrence of any adverse event (Yes/No), Measurement time: the end of the treatment. Duration of adverse event, a difference of dates between start and end of the adverse event (days), Measurement time: the end of the treatment. Intensity of adverse events (Light, Moderate, Severe, Very Severe), Measurement time: the end of the treatment Causal relationship (Very likely, Likely, Possible, Remote), Measurement time: the end of the treatment. Attitude to treatment (No change, Modification of dosage, Temporary interruption, Permanent Interruption), Measurement time: the end of the treatment. Result of the treatment to counteract the adverse event: (Recovered, Improved, Persists, Sequelae), Measurement time: the end of the treatment

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

none

Inclusion criteria:

1.HIV/AIDS patients who are or not associated to an opportunistic malignant disease and who meet the diagnostic criteria. 2.Patients who signed their consent in order to participate in the study. 3.Patients older than 18 years. 4.Patients of both sexes.

Exclusion criteria:

1.Patients with known hypersensitivity to E.Coli cell products or other preparations of rG-CSF. 2.Pregnant patients or breastfeeding.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

4

Target sample size:

184 episodes

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

MD.Giselle

Last Name:

Saurez

Affiliation:

CIMAB S.A

Postal Address:

206 No.1926 e/19 and 21,Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

537-271-5057 Ext.111

Email :

giselle@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

MD.Giselle

Last Name:

Saurez

Affiliation:

CIMAB S.A

Postal Address:

206 No.1926 e/ 19 and 21,Atabey,Playa

City:

Havana City

País:

Cuba

Zip Code:

11600

Telephone:

537-271-5057 Ext.111

Email :

giselle@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000085

Date of Registration in Primary Registry:

2009-08-20

Record Verification Date:

2009-07-28 20:00

Link to the spanish version:

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Effectiveness and Safety of use ior LeukoCIM as prophylaxis and treatment of Neutropenia in patients with HIV / AIDS.

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