Clareo Health | A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine
A Pilot Study to Evaluate the Effects of Subcutaneously Administered Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor in Pediatric HIV-Infected Patients With Neutropenia Secondary to Azidothymidine
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sandoz
Age
0–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Concurrent Medication:
Allowed:
Zidovudine (AZT) on NIAID 86-C-175.
Patients must have:
Diagnosis of perinatal or transfusion acquired AIDS or AIDS related complex.
Granulocytopenia (\< or = to 800 cells/mm3) associated with the administration of AZT on protocol NIAID 86-C-175.
Life expectancy \> 3 months.
Functioning indwelling central venous access device in place.
Prior Medication:
Allowed within 48 hours of study entry:
Prophylactic antibiotics.
You may not be if
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Critically ill or clinically unstable.
Significant, active opportunistic or other infection requiring specific drug therapy at time of study entry.
Ongoing IV alimentation.
Uncorrected nutritional deficiencies that may contribute to anemia and/or leukopenia.
Past history of or current evidence for any chronic hematologic disorder other than hemophilia A or B, anemia of chronic disease or anemia related to HIV infection.
Malignancy likely to require systemic treatment during study.
Patients with the following are excluded:
Critically ill, clinically unstable, or with concomitant diseases listed in Patient Exclusion Co-existing Conditions.
Hypersensitivity to zidovudine (AZT) or any other nucleoside analog.
Prior Medication:
Excluded within 48 hours of study entry:
Antibiotics.
Excluded within 30 days of study entry:
Antiretroviral agents other than zidovudine (AZT).
