Search / Trial NCT00000654

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

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

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Trial Information

Current as of April 22, 2024

Completed

Keywords

Aids Related Opportunistic Infections Pyrimidine Nucleosides Herpesviridae Infections Drug Evaluation Antiviral Agents Hepatitis B

Description

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...

Gender

All

Eligibility criteria

  • 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.

Attachments

readout_NCT00000654_2024-04-22.pdf

4.5 MB

NCT00000654_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Birmingham, Alabama, United States

San Diego, California, United States

Bethesda, Maryland, United States

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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