Perspective: Human Immunodeficiency Virus Type 1 (HIV-1) RNA End Points in HIV Clinical Trials: Issues in Interim Monitoring and Early Stopping

Due to the desire to both shorten the length and reduce the size of clinical trials in human immunodeficiency virus (HIV) disease, the use of surrogate end points such as HIV-1 RNA is becoming increasingly standard. While these end points may be reasonable surrogates for the clinical effectiveness of drugs, a key point in their use as trial end points is the definition of a relevant duration of antiviral response. This definition is often complicated by the desire to perform interim reviews of ongoing laboratory end point trials. Unlike clinical end point trials, in which early clinical response is generally indicative of longer-term follow-up, it is yet to be determined whether short-term viral response adequately predicts the long-term durability of that response

Do State Medical Board Applications Violate the Americans With Disabilities Act?

PURPOSE: To determine whether medical licensing board application questions about the mental or physical health or substance use history of the applicant violate the Americans with Disabilities Act (ADA) of 1990. METHOD: Content analysis of 51 allopathic licensing applications (50 states and District of Columbia) was performed at the University of Medicine and Dentistry of New Jersey-New Jersey Medical School in 2005. Questions referencing physical or mental health or substance use were identified by a team of physicians and reviewed and categorized based on the ADA and appropriate case law by legal counsel. RESULTS: Of the 51 applications reviewed, 49 (96%) contained questions pertaining to the physical or mental health or substance use history of the applicant. Thirty-four of the 49 (69%) state medical licensing applications contained at least one likely impermissible or impermissible item based on the ADA and appropriate case law. CONCLUSIONS: Most state medical licensing applications contain questions that ask about the physical or mental health and substance use of physician applicants. Many licensing applications appear to be in violation of the ADA, even 19 years after enactment of the regulation. These questions do not elicit responses by which professional competence can be judged. The presence of these questions on licensing applications may cause physicians to avoid or delay treatment of personal illness

Preliminary guidelines for the evaluation and management of dyslipidemia in adults infected with human immunodeficiency virus and receiving antiretroviral therapy: Recommendations of the Adult AIDS Clinical Trial Group Cardiovascular Disease Focus Group

Dyslipidemia is a prevalent condition that affects patients infected with human immunodeficiency virus (HIV) who are receiving antiretroviral therapy, These preliminary recommendations summarize the current understanding in this area and propose guidelines for management. Existing guidelines for the management of dyslipidemia in the general population formed the general basis for our recommendations. Data on the prevalence and treatment of dyslipidemia of HIV-infected patients, implications of treatment-related dyslipidemia in other chronically ill populations, and pharmacokinetic profiles for the available hypolipidemic agents in non-HIV populations were considered. Although the implications of dyslipidemia in this population are not fully known, the frequency, type, and magnitude of lipid alterations in HIV-infected people are expected to result in increased cardiovascular morbidity, We propose that these patients undergo evaluation and treatment on the basis of existing guidelines for dyslipidemia, with the caveat that avoidance of interactions with antiretroviral agents is paramoun