Clinical trials of combination therapies for HIV infection
Article Abstract:
There are many issues pertaining to the implementation of combination drug therapies for HIV infection. Studies which may determine the effectiveness of a drug or its possible toxicity are done using tissue cultures (in the laboratory) do not necessarily reflect the effects of the drugs in the human body. Animal models yield important data that are applicable to drug doses in humans. End points which determine the effectiveness of a drug in a clinical trial are critical in this research. But if the end points are aspects of disease progression, the answers will take decades to develop. In a fatal disease, such as AIDS, this is unacceptable. There is a need to establish other reliable end points, such as laboratory markers. However, there are problems with the use of laboratory markers, such as the levels of the viral protein p24, as end points. Some end points may show a synergistic effect of a combination of drugs, while others may show additive effects, and others, no effect. Testing of the validity of the use of laboratory markers must be incorporated into clinical trials. If the toxicity levels are determined for single drugs, it is felt that this does not have to be re-established for their use in combination clinical trials. Animal models could answer questions such as this, very rapidly. With increasing numbers of drugs available with activity against HIV, animal studies are important to establish which combinations work best and which should be tested in clinical trials. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Journal of Acquired Immune Deficiency Syndromes
Subject: Health
ISSN: 0894-9255
Year: 1990
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Development of non-Hodgkin lymphoma in a cohort of patients with severe human immunodeficiency virus (HIV) infection on long-term antiretroviral therapy
Article Abstract:
The acquired immunodeficiency syndrome (AIDS) reduces the function of the immune system, thereby making the patient vulnerable to life-threatening infections. Soon after AIDS was discovered, it was observed that some AIDS patients developed a type of cancer called non-Hodgkin lymphoma, and since then its occurrence in AIDS patients has been increasing steadily. Non-Hodgkin lymphoma is a cancer involving the lymph nodes of the body which may affect the brain. This study assessed the incidence of non-Hodgkin lymphoma in 55 patients with AIDS or AIDS-related complex (ARC) who were receiving antiretroviral drugs. The subjects were being treated with either AZT (azidothymidine) or zidovudine-containing regimens. Eight of the 55 patients (14.5 percent) developed non-Hodgkin lymphoma of the B-cell type an average of 24 months after starting antiretroviral treatment. It was estimated that AIDS patients being treated with antiretroviral drugs have a 29 percent chance of developing lymphoma after 30 months of therapy and a 46 percent chance after 36 months of therapy. It is concluded that AIDS patients being treated with antiretroviral drugs who survive for as long as three years on these drugs have a relatively high chance of developing non-Hodgkin lymphoma. It is possible that the antiretroviral treatment that prolongs life allows the lymphoma to occur at a higher rate, but more research will be needed to determine if this is in fact the mechanism behind the occurrence of the cancer. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 1990
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- Abstracts: Prevalence of HIV infection and high-risk activities in Haiti. Treatment and prophylaxis of Isospora belli infection in patients with the acquired immunodeficiency syndrome
- Abstracts: Design of clinical trials - end points. Design of clinical trials-end points
- Abstracts: Issues in the testing of drug combinations. Insights from monitoring the CPCRA didanosine/zalcitabine trial