Cooper E; National Conference on Human Retroviruses and Related Infections.
Program Abstr Second Natl Conf Hum Retrovir Relat Infect Natl Conf Hum Retrovir Relat Infect 2nd 1995 Wash DC. 1995 Jan 29-Feb 2; 105.
American Foundation for AIDS Research.
Accelerated approval of new anti-HIV compounds is a necessary component of drug development in order to make new compounds quickly available to populations that often have exhausted all other treatment options. However, one undesirable results of the current accelerated approval system for new antiretrovirals is that little information is generated to guide physicians in their decision making regarding when to use these drugs. This presentation will outline a "master antiretroviral trial" that could be utilized as part of an overall accelerated approval strategy that will seek to provide both access to new compounds for the patients who need them, and answers to the questions of how to use them for the physicians who prescribe them. This master protocol will have three principal objectives: first, to broaden access to new agents prior to marketing approval; second, to evaluate the utility of using periodic quantitative virology as a primary means of managing the antiretroviral therapy of patients on an individualized basis; and third, to compare different antiretroviral regimens for degree and duration of clinical benefits. The eligible patient population would consist of HIV positive adults, prospectively stratified on the basis of baseline quantitative viral titers, prior antiretroviral experience, and baseline CD4 counts. All patients would undergo 2 initial randomizations at study entry. The first would be used to assess the utility of quantitative virology as part of the decision to switch antiretroviral regimens, and the second would assess the relative clinical efficacy of combinations of antiretrovirals, including approved and unapproved agents. The effect of the regimens on both clinical and on promising surrogate endpoints would be evaluated, allowing stimulataneous clinical validation of the surrogate candidates across the spectrum of HIV disease and in patients with and without prior antiretroviral treatment.
Publication Types:
Keywords:
- Acquired Immunodeficiency Syndrome
- Adult
- Anti-HIV Agents
- CD4 Lymphocyte Count
- Clinical Protocols
- Clinical Trials as Topic
- HIV
- HIV Infections
- HIV Seropositivity
- Health Personnel
- Humans
- Longitudinal Studies
- psychology
- virology
Other ID:
UI: 102213258
From Meeting Abstracts