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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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) required dose reduction or discontinuation of both antiviral medications due to granulocytopenia when AZT (600 mg/day) was added. A mean nadir ANC of 717 cells/ml was reached at a mean of 5 weeks of concomitant DHPG/AZT therapy in these patients. While recovery of depressed ANC occurred following discontinuation of study medications, progressive CMV infection (most commonly retinitis) occurre...

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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.