NCT00376935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2 hiv-infections

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

January 30, 2012

Completed
Last Updated

November 4, 2021

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

September 14, 2006

Results QC Date

October 4, 2011

Last Update Submit

November 2, 2021

Conditions

HIV Infections

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)

    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.

    Pre-entry, entry, study week 12

Secondary Outcomes (7)

  • Qualitative Hepatitis C Virus RNA

    At study entry

  • Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24

    From randomization to week 24

  • Change in Naive CD4+ Cell Counts From Randomization

    randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24

  • Change in CT Thymic Index From Randomization

    randomization, study week 12

  • Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.

    randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24

  • +2 more secondary outcomes

Study Arms (4)

1

PLACEBO COMPARATOR

Participants will receive palifermin placebo injection on Days 1, 2, and 3

Drug: Palifermin placebo

2

EXPERIMENTAL

Participants will receive palifermin 20 mcg/kg injection on Days 1, 2, and 3

Drug: Palifermin

3

EXPERIMENTAL

Participants will receive palifermin 40 mcg/kg injection on Days 1, 2, and 3

Drug: Palifermin

4

EXPERIMENTAL

Participants will receive palifermin 60 mcg/kg injection on Days 1, 2, and 3

Drug: Palifermin

Interventions

PaliferminDRUG

Keratinocyte growth factor administered via injection

Also known as: rHuKGF
234
Palifermin placeboDRUG

Keratinocyte growth factor placebo administered via injection

Also known as: rHuKGF placebo
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected
  • Receiving potent ART, defined as a combination of three or more antiretroviral drugs for at least 6 months prior to study entry
  • CD4 count of 200 cells/mm3 or less within 30 days prior to study entry
  • Documented CD4 count obtained at study screening
  • Documented current, persistent viral load less than or equal to 200 copies/ml for at least 6 months prior to study entry
  • Willing to use acceptable forms of contraception for the duration of the study

You may not qualify if:

  • Active pancreatitis
  • Androgens, Immunomodulators (e.g., growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons), or investigational ART within 30 days prior to study entry
  • Systemic cancer chemotherapy within 30 days prior to study entry, or history of radiation therapy to the neck and chest regions at any time.
  • Allergy or sensitivity to any component of palifermin
  • Prior treatment with palifermin or other keratinocyte growth factors
  • Current drug or alcohol use that, in the opinion of the investigator, may interfere with study participation
  • Serious illness or recent surgery that requires systemic treatment or hospitalization. Participants who have completed therapy or are clinically stable on therapy for at least 30 days prior to study entry are not excluded.
  • Active cancer
  • HIV-1 RNA levels \>200 copies/mL within 6 months prior to study entry
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

USC CRS

Los Angeles, California, 90033, United States

Location

UCLA CARE Center CRS

Los Angeles, California, 90035, United States

Location

Stanford CRS

Palo Alto, California, 94304, United States

Location

Ucsd, Avrc Crs

San Diego, California, 92103, United States

Location

Harbor-UCLA Med. Ctr. CRS

Torrance, California, 90502, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 33136-1013, United States

Location

The Ponce de Leon Ctr. CRS

Atlanta, Georgia, 30308, United States

Location

IHV Baltimore Treatment CRS

Baltimore, Maryland, 21201, United States

Location

Bmc Actg Crs

Boston, Massachusetts, 02118, United States

Location

Washington U CRS

St Louis, Missouri, 63108-2138, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Columbia P&S CRS

New York, New York, 10032-3732, United States

Location

Trillium Health ACTG CRS

Rochester, New York, 14607, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27514, United States

Location

Duke Univ. Med. Ctr. Adult CRS

Durham, North Carolina, 27710, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt Therapeutics CRS

Nashville, Tennessee, 37204, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98104, United States

Location

Related Publications (4)

  • Aiuti F, Mezzaroma I. Failure to reconstitute CD4+ T-cells despite suppression of HIV replication under HAART. AIDS Rev. 2006 Apr-Jun;8(2):88-97.

    PMID: 16848276BACKGROUND

  • Franco JM, Rubio A, Martinez-Moya M, Leal M, Merchante E, Sanchez-Quijano A, Lissen E. T-cell repopulation and thymic volume in HIV-1-infected adult patients after highly active antiretroviral therapy. Blood. 2002 May 15;99(10):3702-6. doi: 10.1182/blood.v99.10.3702.

    PMID: 11986226BACKGROUND

  • van den Brink MR, Alpdogan O, Boyd RL. Strategies to enhance T-cell reconstitution in immunocompromised patients. Nat Rev Immunol. 2004 Nov;4(11):856-67. doi: 10.1038/nri1484.

    PMID: 15516965BACKGROUND

  • Ye P, Kourtis AP, Kirschner DE. Reconstitution of thymic function in HIV-1 patients treated with highly active antiretroviral therapy. Clin Immunol. 2003 Feb;106(2):95-105. doi: 10.1016/s1521-6616(02)00024-4.

    PMID: 12672400BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Fibroblast Growth Factor 7

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Fibroblast Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Results Point of Contact

Title
ACTG ClinicalTrials.gov Coordinator
Organization
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
ACTGCT.Gov@s-3.com
(301) 628-3313

Study Officials

  • Jeffrey M. Jacobson, MD

    Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 15, 2006

Study Start

December 1, 2006

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

November 4, 2021

Results First Posted

January 30, 2012

Record last verified: 2019-01

Locations

US(22)