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

Launched by RIBOZYOME · Aug 30, 2001

Keywords

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...

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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.