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The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children Clinical research trials and The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children. The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children clinical trial. Test subjects typically receive the most effective healthcare possible for their The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children  The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
For Condition: Herpes Simplex,HIV Infections,Chickenpox
Status: Terminated
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: To obtain tolerance, safety, and pharmacokinetic data for oral valacyclovir hydrochloride ( 256U87 ) in HIV-1 infected children with herpes simplex virus infections ( cold sores ) and/or varicella / zoster virus infections ( chicken pox / shingles ). Varicella and zoster are common problems in HIV-infected children. It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir, resulting in resistance to that drug. Valacyclovir hydrochloride, which converts to acyclovir in the body, increases acyclovir bioavailability by 3-5 fold.
Details: Varicella and zoster are common problems in HIV-infected children. It is believed that chronic oral therapy with acyclovir may result in subtherapeutic concentrations of acyclovir, resulting in resistance to that drug. Valacyclovir hydrochloride, which converts to acyclovir in the body, increases acyclovir bioavailability by 3-5 fold. In the first cohort, patients with stable herpes simplex virus receive valacyclovir hydrochloride at 1 of 2 doses, depending on body surface area (BSA), for 10 days. If acceptable safety is seen at this dose level, a second cohort of patients with stable herpes simplex virus receive a higher dose, depending on BSA, for 10 days. A third cohort of patients with varicella or zoster receive a selected dose based on results from the previous cohorts.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 4 Years/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiretrovirals. - PCP prophylaxis. - IVIG, G-CSF, and erythropoietin. Concurrent Treatment: Allowed: - Transfusions. Patients must have: - Localized mucocutaneous herpes simplex OR undisseminated varicella or zoster. - HIV positive. NOTE: Varicella patients must NOT have AIDS. - CD4 count >= 100 cells/mm3 (herpes simplex or zoster patients) OR >= 250 cells/mm3 (varicella patients). - BSA > 0.6 m2. - Ability to swallow solid dosage formulations. Prior Medication: Allowed: - Prior VZV immune globulin and/or IVIG. - Antiretrovirals if at a stable dose for at least 14 days. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Clinical evidence of pneumonitis. - Severe abdominal pain or back pain. - Encephalopathy. - Hemorrhagic varicella. - Zoster involving ophthalmic branch of trigeminal nerve. - Severe gastrointestinal disorder. Concurrent Medication: Excluded: - Agents with potential activity against HSV or VZV, such as acyclovir, famciclovir, ganciclovir, foscarnet, and sorivudine. - Probenecid. - Aspartamine within 48 hours prior to pharmacokinetic samplings. Patients with the following prior conditions are excluded: - Grade 2 creatinine value within the past 30 days. - Grade 3 hematologic or hepatic values within the past 30 days. - Prior hypersensitivity and/or allergic reaction to acyclovir. - Grade 3 or 4 mental status changes within the past 30 days. Prior Medication: Excluded: - Acyclovir within 1 week prior to study entry. - Steroids within 4 weeks prior to onset of varicella lesions.
Total Enrollment: 28
Location and Contact Information:
Overall Study Official:
KellerMA, Study Chair,
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Univ of Rochester Med Ctr
Rochester, New York, 14642
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: ACTG 253;
Study Start Date:
Record last reviewed: December 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001054
Other Herpes Simplex Studies:
1. The Safety and Effectiveness of Hyperimmune Anti-HIV Intravenous Immunoglobulin (HVIG) Plus Zidovudine in HIV-Infected Infants
2. Immune Response to Influenza Vaccine in HIV-Infected Individuals
3. The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients with HIV and Cryptococcal Meningitis
4. A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients with AIDS
5. Treatment of Chronic Cryptosporidiosis in AIDS Patients
Related Studies:
Other Herpes Simplex Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
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