Clinical trials of combination therapies for HIV infection

Article Abstract:

The goal of treatment of AIDS is to obtain the best quality of life for patients for the longest period of time possible. Combination therapy involves either treatment with multiple drugs at the same time, or alternating or intermittent use of the drugs. Combination drug therapy also overcomes the weakness of the action of one drug against the virus with another drug. An example of this is the use of interferon and zidovudine (ZDV) for patients with Kaposi's sarcoma. The interferon slows the spread of Kaposi's sarcoma, while ZDV has activity against the human immunodeficiency virus (HIV). The length of time the drugs can be used can be extended by either administering the drugs at the same time (at reduced doses), or by sequencing them. The use of combination therapy also slows the development of resistance of the virus to the various drugs, and because lower doses of the drugs can be used, this decreases their toxicity. In combination therapy, it must be determined if drugs are synergistic (their activity together is greater than the effect of the two drugs added together). The synergy of the two types of nucleoside analogues, carbovir and ZDV, was evaluated and analyzed statistically. The drugs were found to be synergistic. Mice, cats, and primates such as monkeys can be used as animal models for human immunodeficiency virus (HIV) infections. These animal models can be used to determine how drugs can be used in combination. There are 13 clinical trials currently ongoing that are testing a combination of drugs. The use of combinations of drugs involves interactions between different drug companies and government agencies. It appears that the development of combination therapies for AIDS will take a long time. (Consumer Summary produced by Reliance Medical Information, Inc.)

Usage, Antiviral agents, Chemotherapy, Combination, Combination chemotherapy, Antiviral agent structure-activity relationships

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Design of clinical trials-end points

Article Abstract:

End points are variables that can be used to evaluate a drug that is being tested in a clinical trial, such as the clinical trials currently underway to evaluate drugs for AIDS. End points should be able to distinguish between the effectiveness of different treatments, and should be prognostic for the clinical outcome. The choice of end points involves many issues. Variables used as end points must be valid for various subpopulations of people, such as those of different races. The viral antigen p24 is being investigated as a laboratory marker that could be used as an end point in AIDS research. However, differences in levels of p24 are seen for various subpopulations; black Africans have been shown to have lower levels of p24 than other populations. End points in trials may be complicated by the use of other drugs which are given to patients as a prophylaxis (given to prevent disease). Multiple end points, or the occurrence of any of a number of possible events, could be used. The use of multiple end points has its advantages, including the opportunity to compare the effects of a treatment on several different end points. (Consumer Summary produced by Reliance Medical Information, Inc.)

Research

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