Herpes SimplexPhase 1NCT00001054
The Safety and Effectiveness of Valacyclovir HCl in the Treatment of Herpes Simplex or Varicella/Zoster Infections in HIV-1 Infected Children
A Phase 1 study testing Valacyclovir hydrochloride in people with Herpes Simplex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Herpes Simplex, HIV Infections, Chickenpox
- What is being tested?
- Valacyclovir hydrochloride
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jan 2001
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Allowed:
- Antiretrovirals.
- PCP prophylaxis.
- IVIG, G-CSF, and erythropoietin.
- Concurrent Treatment:
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- Herpes Simplex, HIV Infections, Chickenpox
- Being tested
- Valacyclovir hydrochloride
- Keywords
- Herpes Zoster, AIDS-Related Opportunistic Infections, Herpes Simplex, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, valacyclovir, Chickenpox
- Medical subject headings
- Herpes Simplex, HIV Infections, Chickenpox, Herpes Zoster, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valacyclovir hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Glaxo Wellcome
- Responsible party
- Sponsor
- Investigators
- Keller MA, Study chairBryson Y, Study chairGershon A, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001054
- Sponsor's protocol ID
- ACTG 253
- Other IDs
- 11230
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
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. doi: 10.1016/s0022-3476(96)70427-4.
PubMed 8551421Cohen JI, Brunell PA, Straus SE, Krause PR. Recent advances in varicella-zoster virus infection. Ann Intern Med. 1999 Jun 1;130(11):922-32. doi: 10.7326/0003-4819-130-11-199906010-00017.
PubMed 10375341
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00001054
- Acronym / sponsor ID
- ACTG 253
- Conditions
- Herpes Simplex, HIV Infections, Chickenpox
- Keywords
- Herpes Zoster, AIDS-Related Opportunistic Infections, Herpes Simplex, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, valacyclovir, Chickenpox
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Glaxo Wellcome
- Study completion
- Jan 2001 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- Antiretrovirals.
- PCP prophylaxis.
- IVIG, G-CSF, and erythropoietin.
- Transfusions.
- Localized mucocutaneous herpes simplex OR undisseminated varicella or zoster.
Key exclusion criteria (22 listed)
- Clinical evidence of pneumonitis.
- Severe abdominal pain or back pain.
- Encephalopathy.
- Hemorrhagic varicella.
- Zoster involving ophthalmic branch of trigeminal nerve.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valacyclovir hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Background: PubMed 8551421von 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. doi: 10.1016/s0022-3476(96)70427-4.
- Background: PubMed 10375341Cohen JI, Brunell PA, Straus SE, Krause PR. Recent advances in varicella-zoster virus infection. Ann Intern Med. 1999 Jun 1;130(11):922-32. doi: 10.7326/0003-4819-130-11-199906010-00017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keller MA study chair
Bryson Y study chair
Gershon A study chair
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Valacyclovir hydrochloride in people with Herpes Simplex and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001054, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.