The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/… (NCT00001054) | Clinical Trial Compass
WithdrawnPhase 1
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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Plain-language 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.
Who can participate
Age range
4 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00001054
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)