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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000085

Enrollment

Unknown

Registered

2009-08-20

Start date

2005-10-05

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neutropenia in patients with HIV/AIDS.

Interventions

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 fr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Cuba

Contacts

Public ContactMD.Giselle Saurez

CIMAB S.A

giselle@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026