AIDS drug trials enter new age

Article Abstract:

AIDS activists have scored a major victory in improving access to experimental AIDS drugs. The usual lengthy process for approving a new drug required by the US Department of Health and Human Services has been waived for the drug dideoxyinosine (ddI). Even though testing has just begun, ddI will be widely available to AIDS patients who have not improved from treatment with the AIDS drug AZT (azidothymidine or zidovudine). Fewer than 100 patients participated in the first phase of the ddI clinical trial, and thus long-term side effects have not been thoroughly assessed. Testing will continue on a larger scale and at the same time the drug will be distributed to patients in need; this revolutionary approach is called parallel track. The handling of ddI may have sparked a trend that will change the way medical research policy responds to many life-threatening diseases. AIDS activists and government statisticians are working together to devise a new approach to conducting drug-testing trials. Their goal is to treat as many AIDS patients as possible while collecting valid research data. This concept is innovative because the traditional thrust of clinical research has not been to treat the participants, but rather to answer scientific questions concerning the safety and effectiveness of treatments. After the data are in and the conclusions have been drawn, the treatment is made generally available. This is perceived as unethical by AIDS activists, who object to the traditional use of placebos (ineffective treatments) in such a fatal disease. Placebos are typically given to half the study participants so that patients using the drug can be compared to those not being affected by it. This means that many who could benefit from the treatment go without it. Instead of comparing death rates for treated and placebo groups, some are suggesting giving the treatment to all participants and testing for clinical markers of immune function. Another proposed change is to loosen study enrollment requirements, thereby rejecting fewer patients who wish to participate. Statistical analysis of the results would have to change, but the data would still be valid, according to one researcher.

Management, Evaluation, Testing, Clinical trials, Mandatory drug testing, Drug testing, Medical statistics, Didanosine

---

New AIDS drugs take careful aim

Article Abstract:

Researchers are working to devise new and more effective drugs to fight AIDS (acquired immunodeficiency syndrome). The latest experimental drugs work in a new way and are based on the most recent discoveries of how HIV (human immunodeficiency virus) infects healthy cells. When HIV attacks an immune cell called a T cell, a cascade of effects begins that eventually destroys the patient's immune function. Fortunately, this virus also provides a convenient target for researchers who are attempting to inactivate HIV, which would halt immune deterioration and prevent AIDS. The target in question is a glycoprotein named gp120, which is attached to the outer coating of the HIV cell. Gp120 binds to the immune cell and assists the viral invasion. Once inside the healthy immune cell, the virus forces the cell to produce the proteins that HIV needs to reproduce itself, and the disease process begins. One experimental drug that has been tested since November 1988 is soluble CD4, which mimics the gp120 binding site on the T cell. The drug puts CD4 into the bloodstream where it circulates, picking up the deadly gp120 on the HIV cells; this keeps gp120 occupied so it cannot bind to T cells. Soluble CD4 does not remain active in the blood for long, so ways of extending its action have been sought. Several laboratories have linked CD4 to immunoglobulin molecules which may preserve function for days instead of hours; they may also act like antibodies and attack infected cells. Perhaps a more promising approach is linking CD4 to a toxin that effectively kills any infected T cells and blocks infection of healthy cells; CD4-toxin drugs will probably be tested on humans in the summer of 1990. Both soluble CD4 and CD4-toxin are the first drugs to directly counteract HIV infection and AIDS; scientists predict they will not be the last. (Consumer Summary produced by Reliance Medical Information, Inc.)

Virus-induced immunosuppression

---

Trials and tribulations of AIDS drug testing

Article Abstract:

When experimental drugs for treating AIDS (acquired immunodeficiency syndrome) are made available to people relatively quickly, difficult situations can develop. This has been illustrated by recent public consternation over articles in the press about the dangers of ddI (dideoxyinosine) and Compound Q. To make ddI more widely available in the fall of 1989, it was offered to people who could not get into formal drug trials, or who could not be helped by AZT (azidothymidine), the only drug approved for treating AIDS. The death rate in the expanded access trials appeared high, but on closer examination, this may not mean that the drug is harmful. Criteria for participation in expanded access meant that the majority of patients were at the end of the therapeutic line, with no other options. The director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, maintains that the majority of suffering connected with ddI is due to AIDS, not the drug. Compound Q, a protein, was approved for drug trials by Genelabs in the spring of 1989, but a consortium of physicians in San Francisco simultaneously began an unauthorized trial of the drug. The trials have now stopped, but the consortium (called Project Inform) will continue with organized, FDA-approved (Food and Drug Administration) trials under the supervision of Sandoz, the Swiss pharmaceutical company. Critics deplore the looseness of this approach, asserting that data demonstrating the effects of Compound Q are weak, but its supporters assert that unconventional approaches are necessary. (Consumer Summary produced by Reliance Medical Information, Inc.)

United States. Food and Drug Administration

Similar abstracts:

• Abstracts: Addressing the Y2K challenge. Greening the campus. Disconnect between Kyoto Protocol and clean energy?
• Abstracts: Down to the wire for the NF gene. New game plan for genome mapping. A common language for physical mapping of the human genome
• Abstracts: Gene transfer test: so far, so good. Gene therapy: into the home stretch. Gene therapy clears first hurdle

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