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

Completed · Phase 2

Conditions studied: Herpes Simplex, HIV Infections, Hepatitis B

In brief

To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are highly and specifically active compounds in vitro against several herpes group viruses, particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral doses are expected to provide concentrations of FIAU exceeding the in vitro minimum inhibitory concentration for nearly all the herpes group viruses.

Key facts

Study ID

NCT00000654

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

78

Expected to finish

1993-02-01

Last updated by the study team

2012-12-18

Who can join

Age: 13 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• Natl Institute of Health — Bethesda, Maryland, United States
• Univ of Washington / Madison Clinic — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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