Search / Trial NCT00002221

Gene Therapy in HIV-Positive Patients With Non-Hodgkin's Lymphoma

Launched by RIBOZYOME · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Lymphoma, Non Hodgkin Bone Marrow Lymphocyte Transformation Hiv 1 Retroviridae Lymphoma, Aids Related Genetic Vectors Transduction, Genetic Gene Transfer Techniques

ClinConnect Summary

In this study, CD34+ cells (stem cells) are transduced with a retroviral vector construct that incorporates multiple ribozymes, a form of RNA with the ability to selectively inhibit gene expression, targeting different sites within the HIV virus. These transduced cells are reinfused into patients as part of a bone marrow transplant procedure for AIDS/lymphoma.

Patients undergoing autologous bone marrow transplantation are entered into this study. A "neutral" retrovirus named "LN" and a retrovirus that contains two ribozyme sequences named "L-TR/Tat-neo" are introduced into the patient's PB...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are 18 to 60 years old.
  • Have been HIV-positive at least since you were diagnosed with non-Hodgkin's lymphoma.
  • Have an HIV level less than or equal to 25,000 copies/ml and a CD4 count of at least 100 cells/mm3.
  • Are currently about to undergo bone marrow transplantation.
  • Have responded well to cancer treatments, including chemotherapy and previous bone marrow transplantation.
  • Agree to use effective barrier methods of birth control, such as condoms, during the study.
  • Are on anti-HIV therapy (HAART).
  • Exclusion Criteria
  • You will not be eligible for this study if you:
  • Have lymphoma affecting your nervous system.
  • Have had any AIDS-related opportunistic infections in the past year.
  • Have heart disease.
  • Are pregnant or breast-feeding.
  • Have severe diarrhea.
  • Have a history of cytomegalovirus (CMV) retinitis.
  • Have dementia or encephalopathy (an infection of the brain).
  • Have a history of another type of cancer (except for skin cancer) before your diagnosis of NHL.
  • Are allergic to etoposide or have had a toxic reaction to prior chemotherapy.

Trial Officials

John Zaia

Study Chair

About Ribozyome

Ribozome is a pioneering biotechnology company focused on the development of innovative RNA-based therapeutics. Leveraging cutting-edge ribozyme technology, Ribozome aims to address unmet medical needs in various therapeutic areas by designing precise and effective treatments that harness the power of RNA to regulate gene expression. With a commitment to advancing healthcare through scientific excellence and collaboration, Ribozome conducts clinical trials to evaluate the safety and efficacy of its drug candidates, fostering breakthroughs that have the potential to transform patient outcomes.

Locations

Duarte, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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