HIV Infections Clinical Trial
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
NCT number | NCT00001054 |
Other study ID # | ACTG 253 |
Secondary ID | 11230 |
Status | Withdrawn |
Phase | Phase 1 |
First received | |
Last updated | |
Est. completion date | January 2001 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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National Institute of Allergy and Infectious Diseases (NIAID) | Glaxo Wellcome |
Cohen JI, Brunell PA, Straus SE, Krause PR. Recent advances in varicella-zoster virus infection. Ann Intern Med. 1999 Jun 1;130(11):922-32. Review. — View Citation
von Seidlein L, Gillette SG, Bryson Y, Frederick T, Mascola L, Church J, Brunell P, Kovacs A, Deveikis A, Keller M. Frequent recurrence and persistence of varicella-zoster virus infections in children infected with human immunodeficiency virus type 1. J Pediatr. 1996 Jan;128(1):52-7. — View Citation
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