CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 99 enrolled
Drug / intervention
Palifermin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00376935
NCT00376935Phase 2Completed

A Double Blind Phase II Study of Multiple Doses of Palifermin (rHuKGF) for the Treatment of Inadequate CD4+ Lymphocyte Recovery in Subjects on Potent Antiretroviral Therapy With Plasma HIV-1 RNA Levels of 200 Copies Per Milliliter or Less

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Sep 15, 2006·Updated Nov 4, 2021

In Brief

A Phase 2 clinical trial evaluating Palifermin and Palifermin placebo for HIV Infections. Completed, enrolled 99 participants across 22 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2006
Enrollment StartDec 1, 2006
Primary CompletionJul 1, 2008
Study CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.8 years ago

Interventions

Palifermindrug

Keratinocyte growth factor administered via injection

Palifermin placebodrug

Keratinocyte growth factor placebo administered via injection