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| Descriptive Information Fields | |||||||||||||
| Brief Title † | The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children | ||||||||||||
| Official Title † | A Phase I Trial to Evaluate the Pharmacokinetics, Safety, and Tolerance of Valacyclovir HCl in HIV-1 Infected Children With Herpes Simplex Infections or Varicella/Zoster Infections | ||||||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase I | ||||||||||||
| Study Type † | Interventional | ||||||||||||
| Study Design † | Treatment, Open Label, Pharmacokinetics Study | ||||||||||||
| Primary Outcome Measure † | |||||||||||||
| Secondary Outcome Measure † | |||||||||||||
| Condition † | Herpes Simplex HIV Infections Chickenpox |
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| Intervention † | Drug: Valacyclovir hydrochloride | ||||||||||||
| MEDLINE PMIDs | 8551421, 10375341 | ||||||||||||
| Links | |||||||||||||
| Recruitment Information Fields | |||||||||||||
| Recruitment Status † | Terminated | ||||||||||||
| Enrollment † | 28 | ||||||||||||
| Start Date † | |||||||||||||
| Completion Date | |||||||||||||
| Eligibility Criteria † | Inclusion Criteria Concurrent Medication: Allowed:
Concurrent Treatment: Allowed:
Patients must have:
Prior Medication: Allowed:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Patients with the following prior conditions are excluded:
Prior Medication: Excluded:
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| Gender | Both | ||||||||||||
| Ages | 4 Years to 12 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts †† | |||||||||||||
| Location Countries † | United States, Puerto Rico | ||||||||||||
| Administrative Information Fields | |||||||||||||
| NCT ID † | NCT00001054 | ||||||||||||
| Organization ID | ACTG 253 | ||||||||||||
| Secondary IDs †† | |||||||||||||
| Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Collaborators †† | Glaxo Wellcome | ||||||||||||
| Investigators † |
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| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||||||
| Verification Date | December 1997 | ||||||||||||
| First Received Date † | November 2, 1999 | ||||||||||||
| Last Updated Date | June 23, 2005 | ||||||||||||