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Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis

NCT00002070 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2005-06-24

No results posted yet for this study

Summary

To determine whether co-administration of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) improves tolerance to ganciclovir in patients previously intolerant because of neutropenia defined as an absolute neutrophil count less than 500 cells/mm3. To assess if improved tolerance of ganciclovir is associated with a favorable outcome as defined by a delayed time to progression of retinitis; to confirm the safety and co-administration of ganciclovir and GM-CSF; to assess the changes in the expression of HIV p24 antigen in the serum and number of T4+ lymphocytes in the blood of patients receiving ganciclovir with or without GM-CSF.

Conditions

  • Cytomegalovirus Retinitis
  • HIV Infections

Interventions

DRUG

Sargramostim

DRUG

Ganciclovir

Sponsors & Collaborators

  • Schering-Plough

    lead INDUSTRY

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00002070 on ClinicalTrials.gov