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NCT00376935 · ClinicalTrials.gov registry record · Phase 2
Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
NCT00376935: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00376935 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 99 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00376935, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
Study Summary
Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected adults.
Primary Outcome
Median and inter-quartile range of the change in absolute CD4 count from baseline to study week 12 were calculated for each treatment arm. Baseline CD4+ count was defined as the average of pre-entry and entry CD4 count. If one evaluation was missing, the other one was used. If a subject missed a week 12 CD4 count evaluation, then the CD4 count evaluation obtained after starting study treatment and closest in time to week 12 (using the earlier evaluation if necessary to break a tie) was used in p
Interventions
- DRUG Palifermin
- DRUG Palifermin placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-09 |
| Phase | Phase 2 |
What the finished NCT00376935 record still lists
NCT00376935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% lower).
The record links to 0 conditions, and to 2 interventions - of which Palifermin is the first listed.
NCT00376935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00376935 about?
NCT00376935 is a clinical study titled "Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults". Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected adults.
What is the current status of trial NCT00376935?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2006-12. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00376935?
The interventions under investigation include: Palifermin (DRUG), Palifermin placebo (DRUG).
Who is sponsoring clinical trial NCT00376935?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00376935's enrollment target sits among peer trials
99 738th of 2000 higher than 1,258 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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