Search / Trial NCT00002070

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

Launched by SCHERING-PLOUGH · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Recombinant Proteins Retinitis Aids Related Opportunistic Infections Neutropenia Ganciclovir Drug Therapy, Combination Granulocyte Macrophage Colony Stimulating Factor Cytomegalovirus Infections Acquired Immunodeficiency Syndrome

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.

About Schering Plough

Schering-Plough, a leading global biopharmaceutical company, is dedicated to the research, development, and commercialization of innovative therapies that address unmet medical needs across a range of therapeutic areas, including oncology, immunology, and infectious diseases. With a commitment to advancing healthcare through scientific excellence, Schering-Plough leverages cutting-edge technologies and collaborative partnerships to bring transformative treatments to patients worldwide. The company's robust pipeline, combined with its focus on patient-centric solutions, underscores its mission to improve health outcomes and enhance the quality of life for individuals facing complex health challenges.

Locations

Philadelphia, Pennsylvania, United States

Atlanta, Georgia, United States

Los Angeles, California, United States

San Francisco, California, United States

Annandale, Virginia, United States

Los Angeles, California, United States

San Francisco, California, United States

Dallas, Texas, United States

New York, New York, United States

New York, New York, United States

Sherman Oaks, California, United States

Chicago, Illinois, United States

New York, New York, United States

Houston, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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