The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU
2 other identifiers
interventional
78
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
February 1, 1993
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedDecember 18, 2012
December 1, 2012
November 2, 1999
December 17, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +3 more criteria
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).
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
Natl Institute of Health
Bethesda, Maryland, 20892, United States
Univ of Washington / Madison Clinic
Seattle, Washington, 98122, United States
Related Publications (1)
Tartaglione T, Hooton TM, Jones T, Smiles K, Corey L. Actg 122: phase II tolerance study of oral FIAU in HIV-infected persons. Int Conf AIDS. 1991 Jun 16-21;7(2):254 (abstract no WB2290)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
D Richman
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
February 1, 1993
Last Updated
December 18, 2012
Record last verified: 2012-12