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

S

Schering-Plough

Status and phase

Completed
Phase 3

Conditions

Cytomegalovirus Retinitis
HIV Infections

Treatments

Drug: Ganciclovir
Drug: Sargramostim

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002070
005A
C88-059

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

14

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems