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Evaluate the Tolerability and Therapeutic Effects of Repeated Doses of Autologous T Cells With VRX496 in HIV

NCT00295477 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-10-23

No results posted yet for this study

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.

Conditions

Interventions

GENETIC

VRX496

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.

Sponsors & Collaborators

Principal Investigators

  • Pablo Tebas, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-04-30
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00295477 on ClinicalTrials.gov