NCT00622232

Brief Summary

The objective of this study is to determine the long term safety and tolerability of an additional infusion of 10 billion VRX496 gene-modified CD4 T cells with a focus on evaluating additional therapeutic benefits with respect to viral load and CD4 counts.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_2 hiv-infections

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
14.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

1.1 years

First QC Date

February 11, 2008

Last Update Submit

June 7, 2011

Conditions

HIV Infections

Keywords

HIV-1treatment experienced, complementary therapies

Outcome Measures

Primary Outcomes (3)

  • To evaluate the safety and tolerability of an additional infusion of VRX496 CD4+ T cells in subjects who previously received VRX496 CD4 T cells under protocol VRX496-USA-05-002.

    9 months

  • To evaluate the change in log10 HIV-1 RNA level

    9 months

  • To evaluate the change between main study baseline CD4 counts and Month 9 post reinfusion

    9 months

Secondary Outcomes (1)

  • Changes in immune function as determined by ICS and TCR vβ Repertoire profile.

    9 months

Interventions

VRX496-transduced autologous CD4 T cellsGENETIC

The cell dose will consist of approximately 10 billion VRX496-transduced autologous CD4 T cells provided as a single bolus infusion.

Eligibility Criteria

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

You may qualify if:

  • Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements.
  • Subjects who have successfully completed participation in the VRX496-USA-05-002 trial.
  • Subjects who initiated or changed to a new ARV regimen more than 3 months prior to Entry Assessment are eligible.
  • Subjects that who (1) if on ARVs and are willing to continue on the current therapy unchanged, or (2) if not on ARV willing to remain off ARVs for the duration of the trial i.e. 9 months. However, if there is clinical need to start or change ARV therapy, then it is permitted to do so.

You may not qualify if:

  • CD4 counts decreased by ≥25% from baseline in main study.
  • Viral load increased by ≥ 1.0 log from baseline in main study or ≥ 200,000.
  • Female subjects who are of reproductive potential who have a positive serum B HCG at the Entry Assessment visit or are not willing to use a reliable method of barrier contraception.
  • Are breast-feeding.
  • Subjects who are actively using injection drugs or other substance abuse (such as extensive alcohol or narcotic use).
  • Any medical condition(s) which, in the opinion of the investigator, would interfere with the subject's ability to participate in or adhere to the requirements of this protocol
  • Active HIV-related or non HIV-related illness
  • Subjects who do not have additional cell product available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CIRCLE Medical, LLC

Norwalk, Connecticut, 06851, United States

Location

Jacobi Medical Center

New York, New York, 10461, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tessio E Rebello, PhD

    VIRxSYS Corporation

    STUDY DIRECTOR

  • David Stein, M.D.

    Jacobi Medical Center

    PRINCIPAL INVESTIGATOR

  • Gary Blick, M.D.

    CIRCLE Medical, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 22, 2008

Study Start

December 1, 2007

Primary Completion

January 1, 2009

Study Completion

June 1, 2023

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

US(2)