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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002070
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: May 1991

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002070 on ClinicalTrials.gov Archive Site
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Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis

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.

Not Provided
Interventional
Phase 3
Primary Purpose: Treatment
  • Cytomegalovirus Retinitis
  • HIV Infections
  • Drug: Sargramostim
  • Drug: Ganciclovir
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria

Patient must have the following:

  • AIDS as defined by CDC criteria.
  • Retinitis as diagnosed by the study ophthalmologist.
  • Performance status 0, 1, or 2.
  • Ability to give informed consent and suitability of intravenous access for scheduled blood tests.
  • Patient may have Kaposi's sarcoma or basal skin cancer.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Active acute infection requiring treatment.
  • Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
  • Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.

Patients with the following are excluded:

  • Active acute infection requiring treatment.
  • Corneal, lens, or vitreal opacification which precludes examination of the fundi, or evidence of retinopathy.
  • Malignancy other than Kaposi's sarcoma (KS) or basal skin cancer.

Prior Medication:

Excluded:

  • Granulocyte macrophage colony-stimulating factor (GM-CSF).
  • Colony stimulating factor.
  • Interleukin 3.
  • Excluded within 7 days of study entry:
  • Zidovudine (AZT).
  • Trimethoprim / sulfamethoxazole (TMP / SMX).
  • Pyrimethamine.
  • Excluded within 30 days of study entry:
  • Biologic response modifiers.
  • Cytotoxic agents.
  • Investigational agents.

Prior Treatment:

Excluded:

  • Radiation therapy.

Required within 1 week of study entry:

  • One or more doses of ganciclovir.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002070
005A, C88-059
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Schering-Plough
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NIH AIDS Clinical Trials Information Service
May 1991

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP