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Clinical research and drug development of antivirals in HIV: an industry perspective

Article Abstract:

Researchers, physicians, and drug companies may need to balance the scientific aspects and the needs of the patients when evaluating experimental drugs for treating life-threatening diseases, particularly human immunodeficiency viral (HIV) disease. A researcher evaluated the different factors that influence the current drug development and approval process. The use of intermediate indicators are important in evaluating disease progression and play a role in determining whether a specific drug is appropriate for widespread use even before the completion of a study. Single-drug therapies may have paved the way for more effective multi-drug therapies. Releasing a drug to the general public based on preliminary study results may give treatment benefit to patients who may not have qualified for the study. However, this practice also complicates the approval process. Early drug release also complicates the labeling process by giving primary physicians incomplete information.

Author: Carter, Stephen K.
Publisher: Lippincott Williams & Wilkins, WK Health
Publication Name: Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology
Subject: Health
ISSN: 1077-9450
Year: 1995
Product development, Pharmaceutical industry, Antiviral agents

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Nucleoside analogue-associated peripheral neuropathy in human immunodeficiency virus infection

Article Abstract:

Antiretroviral drugs for HIV infection may cause or advance distal sensory polyneuropathy (DSP). DSP is also a complication of HIV disease, so drug-related neuropathy should be distinguished from AIDS neuropathy in treating patients. Between 25% and 66% of patients treated with the drug zalcitabine (ddC) develop DSP. Other nucleoside drugs which may contribute to DSP are didanosine and stavudine. Symptoms include prickling sensations, burning in the feet, and numbness. In diagnosing DSP, ankle reflexes, the threshold to vibration in feet, temperature and pinprick sensitivity, and muscle strength should be checked. Laboratory tests may assist in diagnosis in some cases. It may be necessary to lower the amount of drug dosage for patients suffering from medication-caused DSP.

Author: Simpson, David M., Tagliati, Michele
Publisher: Lippincott Williams & Wilkins, WK Health
Publication Name: Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology
Subject: Health
ISSN: 1077-9450
Year: 1995
Care and treatment, Complications and side effects, Peripheral nerve diseases, Peripheral nervous system diseases, Didanosine, Zalcitabine

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Evolution of zidovudine resistance-associated genotypes in human immunodeficiency virus type 1-infected patients

Article Abstract:

The development of zidovudine resistance in HIV infection may proceed differently in different patients. Researchers took blood samples from two HIV-infected hemophiliacs before, during and after zidovudine treatment and analyzed the genetic sequence of the HIV gene that codes for reverse transcriptase (RT). No RT mutations were found in the pretreatment blood samples. Over the course of treatment, however, the RT gene accumulated several mutations known to be associated with zidovudine resistance. However, both patients had mutations at other sites as well. Some mutations arose in one patient but not the other and the mutations appeared at different rates.

Author: Brown, Andrew J. Leigh, Ludlam, Christopher A., Watson, Henry G., Robertson, Pamela, Cleland, Alexander
Publisher: Lippincott Williams & Wilkins, WK Health
Publication Name: Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology
Subject: Health
ISSN: 1077-9450
Year: 1996
Research, HIV (Viruses), HIV, Genetic aspects, Drug resistance in microorganisms, Microbial drug resistance

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Subjects list: HIV infection, Drug therapy, HIV infections
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