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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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