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NCT00001445 · ClinicalTrials.gov registry record · Phase 1
Phase I Study to Evaluate the Safety and Immunogenicity of HIV-1 Immunogen in Children With HIV-1 Infection
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT00001445: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001445 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001445, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a single dose, phase I study to evaluate the safety/tolerance and the immunogenicity of HIV-1 Immunogen, gp120-depleted inactivated HIV-1 preparation in Incomplete Freund's Adjuvant (IFA), in children with HIV-1 infection. A total of 32 children with HIV-1 infection will be enrolled in the study. Arm A of the study will enroll children who have no or moderate immune suppression at the time of study entry as defined by CDC classification and who have no history of and do not require antiretroviral therapy. Antiretroviral treatment given for less than 7 weeks (up to 6 weeks and 6 days) prior to entry will be considered as "no history" of treatment (treatment naive). Arm B will enroll children who have no or moderate immune suppression at the time of study entry as defined by CDC classification and who are on or have received antiretroviral treatment for more than 7 weeks. In order to assess the age-associated impact on the immune response rate, we plan to continue to attempt to enroll infants younger than 24 months of age. Children in each arm will receive 10 units of HIV-1 Immunogen intramuscularly at 0, 3, 6, 9, and 12 months. Antiretroviral treatment will commence once patients meet the criteria for an initiation of the treatment as defined in the protocol. All antiretroviral agents that are currently approved by FDA for clinical indications in HIV-1-infected children (pediatric labeling) are permitted in the protocol. If the child has been receiving a single agent other than ddI, or has been on investigational antiretroviral agents, his/her antiretroviral therapy will have to be changed to an optimal combination regimen of the approved agents at least 6 weeks prior to the enrollment.
Interventions
- BIOLOGICAL HIV-1 Immunogen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 1995-08 |
| Est. Completion | 2001-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001445
The ClinicalTrials.gov registry entry for NCT00001445 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HIV-1 Immunogen is the first listed.
NCT00001445 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001445 about?
NCT00001445 is a clinical study titled "Phase I Study to Evaluate the Safety and Immunogenicity of HIV-1 Immunogen in Children With HIV-1 Infection". This is a single dose, phase I study to evaluate the safety/tolerance and the immunogenicity of HIV-1 Immunogen, gp120-depleted inactivated HIV-1 preparation in Incomplete Freund's Adjuvant (IFA), in children with HIV-1 infection. A total of 32 children with HIV-1 infection will be enrolled in the s...
What is the current status of trial NCT00001445?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 1995-08. Estimated completion is 2001-07.
What interventions are being tested in trial NCT00001445?
The interventions under investigation include: HIV-1 Immunogen (BIOLOGICAL).
Who is sponsoring clinical trial NCT00001445?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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