Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00001125 |
| Other study ID # |
PACTG 391 |
| Secondary ID |
10614ACTG 391 |
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Est. completion date |
March 2004 |
Study information
| 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
|
Clinical Trial Summary
The purpose of this study is to see if the varicella-zoster virus (VZV) vaccine will be safe
and if it can help prevent shingles in HIV-infected children who have already had chickenpox.
VZV is the virus that causes chickenpox. If this virus is reactivated in the body, it can
also cause shingles. Shingles is common in children with HIV who have had chickenpox,
although it is usually not life-threatening. The VZV vaccine used in this study may be able
to prevent HIV-positive children who have had chickenpox from developing shingles.
Description:
Varicella (chickenpox) results from primary infection with VZV. Varicella, a common and
usually benign illness in normal children, is more severe in HIV-infected children and may
result in other conditions such as HZ (shingles). HZ is due to reactivation of latent VZV
acquired during varicella and is common in HIV-infected children who have had natural
varicella. While HZ is not likely to be life-threatening in these children, it does cause
considerable morbidity and interferes with quality of life. Use of a live-attenuated VZV
vaccine may be able to boost immunity in these children.
Two immunologic cohorts are enrolled. Cohort A includes children with a CD4 cell percentage
greater than or equal to 20 percent that has been documented as stable for at least the 6
months prior to the time varicella developed (confirmed by a minimum of 2 tests) and a CD4
cell percentage greater than [AS PER AMENDMENT 10/27/99: or equal to] 15 percent that has
been documented as stable for at least the 6 months prior to enrollment (confirmed by a
minimum of 2 tests). Cohort B includes children with a CD4 cell percentage greater than or
equal to 10 percent and less than 15 percent that has been documented as stable for at least
the 6 months prior to the time varicella developed and stable for at least the 6 months prior
to enrollment (confirmed by a minimum of 2 tests). [AS PER AMENDMENT 4/20/01: Cohort B
includes children who have a CD4 cell percentage less than 15% documented by a minimum of 1
but preferably 2 tests within 1 year of onset of varicella (i.e., within 1 year before to 1
year after varicella) and a CD4 cell percentage greater than or equal to 15% documented by a
minimum of 2 tests at the time of enrollment.] A pilot study precedes the full study. [AS PER
AMENDMENT 10/27/99: The pilot study for Cohort A precedes the full study for Cohort A and the
pilot study for Cohort B. The pilot study for Cohort B precedes the full study for Cohort B.]
The pilot study includes 10 children from each cohort who receive live-attenuated VZV at
Weeks 0 and 8. If 3 pilot-study patients in a cohort meet a toxicity endpoint related to the
vaccine, the dose regimen has failed the safety criteria for that cohort. [AS PER AMENDMENT
10/27/99: If 3 children in the pilot study for Cohort A meet a toxicity endpoint deemed to be
related to the vaccine, the dose regimen has failed safety criteria for both cohorts. If 3
children in the pilot phase of Cohort B meet a toxicity endpoint deemed related to the
vaccine, the dose regimen has failed the safety criteria for Cohort B.] If, at 12 weeks after
immunization, at least 5 pilot-study patients in a cohort respond and the safety profile is
deemed adequate, the pilot study extends into a full study with the immunization of an
additional 20 patients from that cohort. [AS PER AMENDMENT 10/27/99: If, at Week 12, at least
5 pilot-study patients in Cohort A meet immunologic criteria and the safety profile is deemed
adequate, then the full study for Cohort A and the pilot study for Cohort B opens. If the
same immunologic and safety criteria are met for the pilot study for Cohort B, then the full
study for Cohort B opens.] If either cohort shows an inadequate immunologic response or
safety profile, the study team reviews the results to determine if another regimen should be
considered. In the full study, patients receive 2 immunizations, at Weeks 0 and 8. Varicella
antibody titers and in vitro responder cell frequency (RCF) assays are measured at Weeks 0,
4, 8, 12, 24, 52, 78, and 104. Symptoms, HIV progression, and VZV presence are monitored
throughout the study.
