PubMed · 9045023
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A Gómez de la Cámara. 1996-10-19. [Developing a protocol: how and why].. https://pubmed.ncbi.nlm.nih.gov/9045023/
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BACKGROUND: Considerable problems in the management of HIV infection remain, even in the Western world. Not all patients respond satisfactorily to expensive highly active antiretroviral therapy (HAART). Relapses are frequent; often, but not always related to drug resistance, and side effects may be serious. New therapeutic strategies are therefore needed. MATERIAL AND METHODS: A systematic survey was made of protocols for gene therapy available in major databases, as well as of publications on gene therapy of HIV infection and other virus infections. RESULTS: A number of strategies for gene therapy in HIV infection are theoretically possible, several of which are already in phase I trials, in a few cases also in phase II trials. Several strategies are targeting various aspects of the life cycle of HIV, while others are aiming at improving the patient's own immune response to the virus. So far no clinical results have been published. Gene therapy is also in development for certain other viruses, including various herpes viruses as well as hepatitis B and C viruses. Gene therapy for cytomegalovirus retinitis with synthetic oligonucleotides based on the antisense principle is already available in clinical medicine. INTERPRETATION: Valuable information has been gained from the studies, which will be a great value in the further development of gene therapy for HIV infection and for other viral infections.
BACKGROUND: There has been a substantial increase in our understanding of the pathogenesis of cancer over the past decades, and new treatment modalities are being developed on the basis of this knowledge. MATERIAL AND METHODS: The literature is reviewed, and the status of gene therapy protocols approved in Norway is presented. RESULTS: About 70% of the more than 400 clinical gene therapy studies started are targeted at cancer. Several different principles are used, including gene therapy targeted at tumour suppressor genes, oncogenes, or central signaling molecules, as well as "suicide gene" therapy. In addition, various gene therapy protocols aim at strengthening immune responses. Most studies have been early clinical trials primarily designed to study safety, applicability and toxicity. Several of these phase I and II studies have, however, shown partial remission of tumours and, in rare cases, complete remission, although curation has not yet been shown. In some trials, including TP53 gene therapy trials, effects on tumour size have been observed in up to 50% of the patients. Up until now, only two phase III and one phase II/III studies have been initiated, but results from these studies have not yet been published. The two first gene therapy protocols approved in Norway are also targeted at cancer. So far, six patients in Norway have undergone gene therapy. INTERPRETATION: As of today, the results should be seen as promising for some of the principles which are being tried out; their clinical importance must, however, be documented in larger controlled clinical trials.
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