Suppression of Cytomegalovirus Retinitis Utilizing High Dose Intravenous Acyclovir and Oral Zidovudine in Patients With AIDS

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

Keywords

ClinConnect Summary

CMV retinitis is one of the most common opportunistic infections in patients with AIDS. DHPG is at present the only drug available for widespread compassionate use in the United States. Although most patients respond to treatment with DHPG, the medication does not cure the infection. Most patients will have a relapse and will require retreatment with DHPG. Because of the large relapse rate, most people treated for CMV retinitis are placed on continuous treatment with DHPG. There are two major problems associated with ongoing use of DHPG: 1) The development of a low white blood cell (WBC) co...

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Eligibility criteria

• • Inclusion Criteria
• Prior Medication:
• Required:
• • Patients must have successfully completed remission induction therapy with ganciclovir (minimum of 14 days of therapy) for acute cytomegalovirus (CMV) retinitis within the preceding 48 hours. Patients who show no evidence of progressive disease are considered to have met criteria for successful induction.
• Amended to allow:
• • Investigational triazoles.
• • Human recombinant erythropoietin (Eprex).
• • Other investigational non-antiviral therapies offered through treatment IND.
• Patients must:
• • Have HIV infection as determined by a commercially licensed ELISA test confirmed by a licensed Western blot
• • Have salvageable vision (corrected acuity of 20/100 or better) in at least one eye.
• • Be capable of signing an informed consent.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following are excluded:
• • Known or suspected allergy to one of the study medications.
• • Inability to maintain adequate hydration status.
• Concurrent Medication:
• Excluded:
• • Concurrent therapy with nephrotoxic agents.
• • Systemic therapy for another opportunistic infection.
• • Systemic prophylaxis for Pneumocystis carinii pneumonia (PCP).
• • Probenecid.
• • Patients are advised that validity of this trial may be jeopardized by use of other potentially antiviral or immunomodulating treatments.
• Patients with the following are excluded:
• • Known or suspected allergy to one of the study medications.
• • Inability to maintain adequate hydration status.
• Prior Medication:
• Excluded within 2 weeks of study entry:
• • Steroids.
• • Cytotoxic or immunosuppressive drugs.
• • Investigational agents. (Amended to now allow these.) Immunomodulatory drugs (except ganciclovir).
• Prior Treatment:
• Excluded within 2 weeks of study entry:
• • Radiotherapy.
• Risk Behavior:
• Excluded:
• • History of unreliable drug intake and inability to cooperate in the testing procedures. Unwilling or unable to give informed consent or unwilling to sign approved consent form.