The Safety and Effectiveness of FIAC in the Treatment of Cytomegalovirus (CMV) in Patients With AIDS

Inclusion Criteria

Concurrent Medication:

Allowed:

• Pentamidine aerosol for prophylaxis of recurrent Pneumocystis carinii pneumonia (PCP) in patients currently receiving such treatment.

Prior Medication:

Allowed:

• Zidovudine (AZT) but only if patient has been taking the drug for > 6 weeks at a dose = or < 600 mg/day, and had < 10 percent decrease in hematocrit, neutrophils, and platelets in the last 30 days. Those off AZT must have been off it for > 1 month.

Patients must:

• Have documented cytomegalovirus (CMV) viremia or viruria.
• Have a diagnosis of HIV infection by ELISA or Western blot.
• Be able to participate as an outpatient.
• Be ambulatory.
• Grade 0 or 1 AIDS Clinical Trial Group toxicity grades for specified laboratory tests.
• Be competent to sign informed consent.
• Be able to cooperate with the treatment plan and evaluation schedule.

NOTE:

• The screening tests must be initiated and completed within 4 weeks prior to the first dose of FIAC.

Concomitant diseases allowed:

• Stable mucocutaneous Kaposi's sarcoma.
• Superficial or uncomplicated infections such as thrush.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• HIV wasting syndrome (involuntary weight loss > 10 percent of baseline body weight and/or chronic diarrhea or weakness and documented fever for at least 30 days).
• Clinical or x-ray evidence of bronchitis, pneumonitis, pulmonary edema, effusion, or suspected active tuberculosis.
• Any unstable medical condition including serious cardiovascular, infectious, oncologic, renal, or hepatic condition.
• Cytomegalovirus end organ disease.
• Kaposi's sarcoma requiring chemotherapy.
• Systemic fungal infection requiring amphotericin therapy.
• Diagnosis of idiopathic thrombocytopenic purpura (persistent platelet counts < 100000 platelets/mm3 for = or > 3 months).

Patients with the following are excluded:

• HIV wasting syndrome.
• Clinical or x-ray evidence of bronchitis, pneumonitis, pulmonary edema, effusion, or suspected active tuberculosis.
• Any unstable medical condition including serious cardiovascular, infectious, oncologic, renal, or hepatic condition.
• Cytomegalovirus (CMV) end organ disease e.g., retinitis, hepatitis, gastroenteritis.

Prior Medication:

Excluded within 4 weeks of study entry:

• Zidovudine (AZT).
• Acyclovir.
• Ganciclovir (DHPG).
• Foscarnet.
• Interferon.
• Other drug with putative anticytomegaloviral activity.
• Any immunostimulating drug not specifically allowed.