HIV InfectionsPhase 3NCT00002358
A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV
A Phase 3 study testing Sorivudine in people with HIV Infections and Chickenpox, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- HIV Infections, Chickenpox
- What is being tested?
- Sorivudine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients must have:
- HIV infection.
- Cutaneous, visceral, or ocular varicella-zoster viral infection.
- Refractory or intolerant to acyclovir or foscarnet therapy.
- Consent of parent or guardian.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Inability to take oral capsules or tolerate liquids.
- Concurrent Medication:
- Excluded:
- 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid.
Show all 13Show fewer
- Patients with the following prior condition are excluded:
- History of immediate hypersensitivity to nucleoside analogues.
- Prior Medication:
- Excluded:
- 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry.
- Required:
- Prior acyclovir or foscarnet.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bristol - Myers Squibb Co
Wallingford, Connecticut, 06492
About this study
Official title: Open-Label BV-araU Treatment of Pediatric HIV-Infected Patients With Cutaneous, Visceral, or Ocular Varicella-Zoster Viral Disease Who Have Failed or Are Intolerant of Standard Therapy
To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy.
Read the detailed description
Any physician qualified to treat pediatric AIDS patients may enroll patients in this study.
- Conditions
- HIV Infections, Chickenpox
- Being tested
- Sorivudine
- Keywords
- Herpes Zoster, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, sorivudine, Chickenpox
- Medical subject headings
- HIV Infections, Chickenpox, Herpes Zoster, 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.
SorivudineDrug
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 3
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002358
- Sponsor's protocol ID
- 255A
- Other IDs
- AI458-903
- Status last verified
- Oct 2007
- First submitted
- 2 Nov 1999
- Last updated
- 2 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label BV-araU Treatment of Pediatric HIV-Infected Patients With Cutaneous, Visceral, or Ocular Varicella-Zoster Viral Disease Who Have Failed or Are Intolerant of Standard Therapy
- ClinicalTrials.gov ID
- NCT00002358
- Acronym / sponsor ID
- 255A
- Conditions
- HIV Infections, Chickenpox
- Keywords
- Herpes Zoster, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, sorivudine, Chickenpox
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- 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 provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy.
Detailed description
Any physician qualified to treat pediatric AIDS patients may enroll patients in this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- HIV infection.
- Cutaneous, visceral, or ocular varicella-zoster viral infection.
- Refractory or intolerant to acyclovir or foscarnet therapy.
- Consent of parent or guardian.
Key exclusion criteria (13 listed)
- Inability to take oral capsules or tolerate liquids.
- 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid.
- History of immediate hypersensitivity to nucleoside analogues.
- 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry.
- Prior acyclovir or foscarnet.
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 |
|---|---|---|
| Sorivudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2007.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sorivudine in people with HIV Infections and Chickenpox, run by Bristol-Myers Squibb at 1 site in United States.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 2 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 2 Oct 2007.