NCT00295477

Brief Summary

The study is intended for individuals who are doing well on HAART therapy. In Step 1 of the trial, individuals will be given up to 6 infusions of the study drug VRX496 to see the effect on viral load and CD4 counts. If individuals have no serious adverse effects from the infusions of VRX496 and the viral load and CD4 counts remain stable, they may go on to Step 2 of the study. In Step 2, individuals will stop taking their HAART medication and their viral load, CD4 counts and the number of VRX496 in T cells will be monitored. All subjects who receive VRX496 T cells will enroll in a Long-Term Follow-up study to monitor subjects. Subjects will be followed every 6 months for five years following the 1st infusion of the T cells. If the VRX496 T cells are no longer found in the blood after five years, then subjects will be contacted yearly for the next 10 years. If the VRX496 T cells are found in the blood at five years after the 1st infusion of T cells, then the subjects will continue to be seen once a year until the VRX496 T cells are no longer found in the blood for a maximum of 15 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 hiv

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1 hiv

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2006

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

4.2 years

First QC Date

February 21, 2006

Last Update Submit

October 21, 2019

Conditions

HIV

Keywords

HIVTreatment Experienced

Outcome Measures

Primary Outcomes (3)

  • Incidence of serious adverse events & dose related toxicity.

    18 months

  • Effects on viral load and CD4 counts from baseline through STI.

    18 months

  • Estimate antiviral effects of VRX496 after STI.

    18 months

Secondary Outcomes (1)

  • Determine persistence and number of VRX496 containing T cells

    18 months

Interventions

VRX496GENETIC

In Step 1 of the protocol, each subject will receive up to 2 cycles of VRX496. Each treatment cycle consists of 3 infusions of VRX496.

Eligibility Criteria

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

You may qualify if:

  • HIV-1 positive by western blot or detection of HIV RNA in blood and responding to combination antiviral therapy
  • No changes in antiretroviral medications within past 4 weeks of study entry and willing to continue on current therapy for the duration of the study
  • years of age and older
  • Karnofsky Performance score of greater than 80
  • HIV viral load \< 59 copies/mL
  • CD4 T cell count \> 350 cells per uL
  • adequate venous access

You may not qualify if:

  • HIV seroconversion within past year
  • History of cancer (other than a removed basal or squamous cell of the skin)
  • History of congestive heart failure.
  • Previous treatment with HIV experimental vaccine within past year
  • Previous treatment with any gene therapy
  • Positive serology for Vesicular Stomatitis Virus (VSV-G or VSV-G DNA)
  • Currently breastfeeding, pregnant, or unwilling to use birth control
  • Using oral corticosteroids, hydroxyurea, or immunomodulating agents (IL-2, interferon-gamma, granulocyte colony stimulating factors, megestrol acetate) within the past 30 days or foresee the need to use these during the study period.
  • Are presently drug or alcohol dependent
  • Have other serious illness or acute opportunistic infection or bacterial infection requiring systemic treatment and/or hospitalization within the past 30 days
  • Have chronic hepatitis B or hepatitis C
  • Have an active AIDS defining illness
  • Have an allergy or hypersensitivity to human serum albumin, DMSO or Dextran 40
  • Have diabetes or a coagulopathy with in the opinion of the investigator would exclude subjects from participating in rectal biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Tebas P, Stein D, Binder-Scholl G, Mukherjee R, Brady T, Rebello T, Humeau L, Kalos M, Papasavvas E, Montaner LJ, Schullery D, Shaheen F, Brennan AL, Zheng Z, Cotte J, Slepushkin V, Veloso E, Mackley A, Hwang WT, Aberra F, Zhan J, Boyer J, Collman RG, Bushman FD, Levine BL, June CH. Antiviral effects of autologous CD4 T cells genetically modified with a conditionally replicating lentiviral vector expressing long antisense to HIV. Blood. 2013 Feb 28;121(9):1524-33. doi: 10.1182/blood-2012-07-447250. Epub 2012 Dec 20.

    PMID: 23264589DERIVED

Related Links

MeSH Terms

Interventions

lexgenleucel-T

Study Officials

  • Pablo Tebas, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 23, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2010

Study Completion

December 1, 2013

Last Updated

October 23, 2019

Record last verified: 2019-10

Locations

US(1)