|
The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU Clinical research trials and The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU clinical trial. Human subjects often get the best healthcare possible for their The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU  The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
For Condition: Herpes Simplex,HIV Infections,Hepatitis B
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Oclassen Pharmaceuticals
Synopsis: 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.
Details: 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. HIV-infected patients with Karnofsky scores at least 80 (with or without documented recurrent herpes group infections) are successively entered into consecutively studied, escalating dose cohorts. There are a total of 4 dose cohorts of FIAU and each patient takes the required amount of FIAU syrup every 8 hours, 1 hour prior to or 3 hours after meals, for a total of 14 days. Entry of new patients at the next higher dose is based on results of tolerance and safety data for prior cohort when all 10 have received 14 days of therapy and at least 7 have met all of the tolerance criteria. Although not formally randomized due to the sequential nature of the study and serious medical condition of the patients, every attempt to avoid bias in assigning a patient to a dose is made. Patients are entered starting with the first dose cohort. Upon meeting the enrollment and tolerance criteria for dose escalation, up to 5 patients with a history of chronic HBV infection and surface antigen positive at their screening visit are added to the end of each dose cohort. Plasma samples are taken to determine peak and trough levels of FIAU at Days 1, 3, 7, and 14 or at last visit. Patients with ongoing active infections are followed by culture (HSV, VZV and CMV) or test (HBV) at Days 1, 3, 7, and 14. Antiemetic therapy with Reglan, Compazine, and Trilafon is given concomitantly at the discretion of the investigator and tolerance determined with antiemetic therapy ongoing. Patients are advised to avoid heavy exercise within 24 hours of any laboratory tests.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/65 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 78
Location and Contact Information:
Overall Study Official:
DRichman, Study Chair,
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
Univ of Washington / Madison Clinic
Seattle, Washington, 98122
United States
Natl Institute of Health
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: ACTG 122 FIAU; R90-001-01, 02, 03, 04
Study Start Date:
Record last reviewed: September 1993
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000654
Other Herpes SimplexStudies:
1. The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
2. Oral acyclovir for neonatal HSV disease of the skin,eyes and mouth
3. Herpetic Eye Disease Study (HEDS) II
4. A Study to Compare the Efficacy and Safety of Valacyclovir Hydrochloride ( 256U87 ) Versus Acyclovir in the Treatment of Recurrent Anogenital Herpes Infections in HIV Infected Patients
5. SP-303T Applied to the Skin of Patients with Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success with Acyclovir
Related Studies:
Other Herpes Simplex Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
|
|
|
|
|
|
|
|
