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Thymalin

Thymulin, Thymic Factor, Serum Thymic Factor, Facteur Thymique Serique

Quick Stats
Studies 202
Trials 37
Completed PHASE2 INTERVENTIONAL NCT00376935

Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed Description

Antiretroviral therapy (ART) has dramatically improved the clinical outcome for HIV infected adults; however, some people on potent ART experience poor recovery of CD4 counts despite maximum suppression of viral load. Such uncontrolled HIV infection is associated with the reduced ability by the human body to create new T cells (or thymopoiesis). HIV infected adults experiencing reduced thymopoiesis are at increased risk of clinical disease progression. The thymus is the primary site for CD4 cell development; research suggests that keratinocyte growth factor (KGF) may enhance thymus activity in individuals who exhibit reduced thymopoiesis. Palifermin is a modified version of the naturally occurring KGF that is approved to treat people with hematologic malignancies. The purpose of this study is to evaluate the safety and efficacy of palifermin in increasing CD4 counts, through enhanced thymopoiesis, in treatment-experienced HIV infected adults with suppressed viral loads but low CD4 counts. This study will last 24 weeks. Participants will be randomly assigned to one of four arms: * Arm A participants will receive placebo * Arm B participants will receive palifermin 20 mcg/kg * Arm C participants will receive palifermin 40 mcg/kg * Arm D participants will receive palifermin 60 mcg/kg Participants will receive intravenous doses of their assigned intervention on Days 1, 2, and 3. All participants must remain on their current ART regimen for the duration of the study. ART will not be provided by the study. There will be six study visits, and they will occur at Weeks 1, 2, 4, 8, 12, and 24. All visits will include a targeted physical exam and blood and urine collection.

Interventions

Name: Palifermin
Type: DRUG
Description: Keratinocyte growth factor administered via injection
Name: Palifermin placebo
Type: DRUG
Description: Keratinocyte growth factor placebo administered via injection

Primary Outcomes

Measure: Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)
TimeFrame: Pre-entry, entry, study week 12
Description: 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 place of the missing week 12 evaluation.

Trial Information

NCT ID

NCT00376935

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last Updated

December 15, 2025