The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU

Inclusion Criteria

Concurrent Medication:

Allowed:

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

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.

Patients must:

• Have a diagnosis of HIV infection by ELISA or Western blot. Be able to participate as an outpatient.
• Be ambulatory.
• Have 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 FIAU, except for diagnostic herpes simplex virus (HSV), varicella zoster (VZV), or cytomegalovirus (CMV) cultures which may have been done previously.
• Concomitant diseases allowed:
• Stable mucocutaneous disease.
• 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 infections or cardiovascular, oncologic, renal, or hepatic condition.
• Primary or initial infection with herpes simplex (HSV), varicella zoster (VZV), or hepatitis B (HBV).
• Cytomegalovirus (CMV) 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, infections, oncologic, renal, or hepatic condition.
• Primary or initial infection with herpes simplex (HSV), varicella zoster (VZV), or hepatitis B (HBV).
• Cytomegalovirus (CMV) end organ disease.

Prior Medication:

Excluded within 4 weeks of study entry:

• Ganciclovir (DHPG).
• Foscarnet.
• Interferon.
• Other drug with putative antiviral activity (except zidovudine (AZT)).
• Any immunostimulating drug not specifically allowed.

Excluded within 1 week of study entry:

• Acyclovir.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety