Status:

COMPLETED

The Safety and Effectiveness of Ganciclovir Used Alone or in Combination With Granulocyte-Macrophage Colony Stimulating Factor in the Treatment of Cytomegalovirus (CMV) of the Eye in Patients With AIDS

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Schering-Plough

Hoffmann-La Roche

Conditions:

Cytomegalovirus Retinitis

HIV Infections

Eligibility:

All Genders

13-65 years

Phase:

NA

Brief Summary

AMENDED: To evaluate the effect of sargramostim ( GM-CSF ) on modulating the granulocytopenia associated with concomitant DHPG and AZT therapy ( Phase B ), in terms of time to development of granulocy...

Detailed Description

AMENDED: In ACTG 004, among 11 AIDS patients with CMV infection receiving DHPG maintenance therapy (5 mg/kg, 5x/week) with stable white blood cells (WBC)/absolute neutrophil counts (ANC) 7 (64 percent...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Maintenance therapy for stable opportunistic infection which is not myelosuppressive.
  • Aerosolized pentamidine for prophylaxis of Pneumocystis carinii pneumonia.
  • Acyclovir or other appropriate medications for appearance of Herpes simplex virus or Varicella zoster virus infections (after enrollment in study) that require systemic therapy.
  • Medications absolutely necessary for the patient's welfare, at discretion of investigator.

Patients must:

  • Have a diagnosis of sight-threatening cytomegalovirus (CMV) retinitis and AIDS.
  • Have at least one pending culture for cytomegalovirus (CMV) from buffy coat and/or urine prior to study entry or previously documented CMV viremia or viruria within 6 weeks prior to study entry.
  • Be capable of giving informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Corneal, lenticular, or vitreal opacification that precludes examination of the fundi, or evidence of other retinopathy other than cotton wool spots.

Concurrent Medication:

Excluded:

  • Systemic antiviral therapy except Zidovudine (AZT) which will be added during the extended maintenance phase of the study.
  • Foscarnet.
  • Treatment for an active AIDS-defining opportunistic infection.
  • Any potentially cytotoxic chemotherapeutic agent.

Patients with the following are excluded:

  • Corneal, lenticular, or vitreal opacification that precludes examination of the fundi, or evidence of other retinopathy other than cotton wool spots.

Prior Medication:

Excluded within 14 days of study entry:

  • Other immunomodulators, biologic response modifiers, or investigational agents.
  • Protocol drugs.
  • Foscarnet.
  • Any potentially cytotoxic chemotherapeutic agent.

Prior Treatment:

Excluded within 14 days of study entry:

  • Administration of cytomegalovirus hyperimmune globulin in therapeutic doses.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

July 1 1992

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00000989

End Date

July 1 1992

Last Update

November 4 2021

Active Locations (4)

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Page 1 of 1 (4 locations)

1

UCLA CARE Center CRS

Los Angeles, California, United States, 90095

2

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, United States, 02215

3

Memorial Sloan-Kettering Cancer Ctr.

New York, New York, United States, 10021

4

Unc Aids Crs

Chapel Hill, North Carolina, United States, 275997215