Design considerations for AIDS trials

Article Abstract:

There are differences between AIDS and other diseases which must be taken into consideration when designing clinical trials. These differences include the following: AIDS is an epidemic; AIDS is an infectious disease that may possibly be prevented, treated or even cured; there are many new drugs that have been developed which need to be evaluated; and there is a demand from the patients that something be done immediately. The goals that must be kept in mind when designing clinical trials for the treatment of AIDS are: the time necessary for drug evaluation must be minimized; the tests used to evaluate the treatment need to be reliable; and the needs of the patients must be met. Nine issues that must be taken into account when designing clinical trials for AIDS are discussed. One issue is speeding up progress through the phases of research for a particular drug. These phases include those which establish proper dose levels and toxicity levels; those that demonstrate the activity of the drug, and those that compare the effectiveness of one drug with other drugs. It is possible that studies can combine the demonstration of activity and comparison of effectiveness to speed the evaluation along. Another issue is use of randomization, blinding, and placebos. These approaches are not desired by patients with AIDS, but randomization, when some patients receive the treatment and others receive no treatment or a placebo, appears to be the best way to determine the effectiveness of a treatment. Also to be considered is the relaxation of criteria for entry into trials, so that most people will be eligible to enter clinical trials if they wish to. The use of endpoints other than death to evaluate treatment, such as disease progression, the development of new signs and symptoms of disease, or the appearance of opportunistic infections, is discussed. Another issue is that trials must be adaptable to new data, with the possible addition of supplementary treatment for patients that are in the trial. It is concluded that flexible and imaginative trials can be designed that will meet the needs of the AIDS patients. (Consumer Summary produced by Reliance Medical Information, Inc.)

Planning, Clinical trials, Drug therapy, AIDS patients

---

Implications of an alternative approach to dose-response trials

Article Abstract:

Data regarding the safety and efficacy of new drugs can come from various types of studies, not just from randomized controlled trials, which are very stringent. The randomized controlled trials do allow greater ease of data analysis, such that simple methods of analysis are sufficient for comparison and interpretation. The conclusions reached in randomized trials also tend to be highly reliable. However, the benefits of less stringent trials include: increased relevance of data to clinical decisions; collection of a greater amount of data; less expense for the gathering of data; and fewer ethical constraints placed on the gathering of data because the eligibility requirements for participants in the trials are not as strict. A particular type of trial, known as the dose-response trial, is compared with the more stringent randomized controlled trial. Dose-response trials study the effects of different doses of a drug in patients. The goals of the dose-response trials are to test the effectiveness of a drug and to determine the appropriate dosage. Alternative types of dose-response trials, other than those used in randomized controlled trials, can be used to evaluate drugs without losing important information, and yet patients can gain from the benefits. A design of the dose-response trial known as the parallel-dose design assigns one of several doses to each patient. Another design, the crossover design, assigns several dosages to each patient. The dose-escalation design is when patients are first given a placebo, then a low dose of the drug, and then increasing dosages until a clinical end point is achieved or there is an unacceptable level of toxicity. The dose-escalation approach has greater clinical benefits than the other designs while also providing the data which the study was designed to obtain. (Consumer Summary produced by Reliance Medical Information, Inc.)

Methods, Models, Drugs, Testing, Bayesian statistical decision theory, Bayesian analysis, Pharmaceutical research

---

Interferon-alpha treatment leads to accumulation of virus particles on the surface of cells persistently infected with the human immunodeficiency virus type 1

Article Abstract:

Interferon (IFN) is a substance produced by cells of the immune system which is known to have activity against viruses. IFN has been shown to suppress the production of the human immunodeficiency virus type 1 (HIV-1) in tissue culture (in the laboratory). Studies in mice show that IFN-alpha inhibits production of the virus in the body, but that the proteins of the virus are still synthesized. Virus particles are seen on the surface of infected cells that have been treated with IFN-alpha, but the viruses are not released from the cell surface. The effect of IFN-alpha on viral production in human cells that are either acutely infected with HIV-1 (producing virus for a short period of time, but in large quantities) or persistently infected with HIV-1 (producing virus for long periods of time, but in small quantities) was examined. There was suppression of virus in both types of cells. As seen in the mouse studies, the proteins of the virus were still produced, and the completed virus was found on the surface of infected cells. Thus, IFN-alpha appears to be involved in the suppression of the release of intact virus from infected cells. The results suggest that IFN-alpha may be useful in the treatment of individuals who are infected with HIV, and that it may suppress the occurrence of disorders that occur due to infection. (Consumer Summary produced by Reliance Medical Information, Inc.)

Antiviral agents, Interferon alpha

Similar abstracts:

• Abstracts: Economic and policy implications of early intervention in HIV disease. How many physicians can we afford?
• Abstracts: Oncology. Screening strategies for cancer: implications and results
• Abstracts: Vaginal sonography findings and hCG dynamics of early intrauterine and tubal pregnancies. Comparison of abdominal and vaginal sonography in suspected ectopic pregnancy
• Abstracts: 'Decade of Brain' holds promise for answers to schizophrenia. Improved screening for prostate cancer offers challenging new data to cope with high incidence
• Abstracts: You can teach an old dog new tricks: how AIDS trials are pioneering new strategies. Design considerations for AIDS trials

This website is not affiliated with document authors or copyright owners. This page is provided for informational purposes only. Unintentional errors are possible.