Related Experiment Video

Updated: Jun 7, 2026

An Affordable HIV-1 Drug Resistance Monitoring Method for Resource Limited Settings
19:57

An Affordable HIV-1 Drug Resistance Monitoring Method for Resource Limited Settings

Published on: March 30, 2014

Development of diagnostic criteria for serious non-AIDS events in HIV clinical trials

Alan R Lifson1, , Waldo H Belloso

  • 1Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota 55454-1015, USA. lifso001@umn.edu

HIV Clinical Trials
|October 27, 2010
PubMed

Insights

Standardized criteria for serious non-AIDS (SNA) diseases were developed for HIV clinical trials. These definitions improve the reporting and validation of important health events in patients receiving highly active antiretroviral therapy (HAART).

Area of Science:

  • HIV/AIDS Research
  • Clinical Trials Methodology
  • Epidemiology of Non-AIDS Diseases

Background:

  • Serious non-AIDS (SNA) diseases significantly contribute to morbidity and mortality among individuals with HIV/AIDS, even during the highly active antiretroviral therapy (HAART) era.
  • Standardized definitions for SNA events are crucial for accurate data collection and analysis in clinical trials.

Purpose of the Study:

  • To develop standardized criteria for 12 specific serious non-AIDS (SNA) events.
  • To facilitate the use of these criteria by Endpoint Review Committees (ERCs) in multicenter international HIV clinical trials, such as the START trial.

Main Methods:

  • Criteria were derived from a previous trial (SMART) and extensive literature review.
  • An iterative consultation process with the ERC and content experts refined the definitions.
  • Draft criteria were evaluated using retrospectively collected data from the ESPRIT trial.

Main Results:

  • Finalized criteria for 12 SNA events including cardiovascular, liver, renal, and oncological conditions.
  • In the ESPRIT trial, 72% of reviewed potential SNA events met "confirmed" criteria and 13% met "probable" criteria.
  • Twenty-eight percent of cases required adjudication for final decision, highlighting the need for expert review.

Conclusions:

  • Standardized SNA definitions are essential for optimizing event reporting and validation in HIV clinical trials.
  • Review by an experienced Endpoint Review Committee (ERC) with adjudication capabilities is recommended for accurate assessment of clinical outcomes.
Abstract

More Related Videos

Rapid Screening of HIV Reverse Transcriptase and Integrase Inhibitors05:46

Rapid Screening of HIV Reverse Transcriptase and Integrase Inhibitors

Published on: April 9, 2014

Comprehensive & Cost Effective Laboratory Monitoring of HIV/AIDS: an African Role Model23:56

Comprehensive & Cost Effective Laboratory Monitoring of HIV/AIDS: an African Role Model

Published on: October 31, 2010

Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Clinical Trials01:16

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
Cryptococcal Meningitis01:27

Cryptococcal Meningitis

Cryptococcal meningitis is a life-threatening opportunistic infection predominantly associated with HIV/AIDS, accounting for over 100,000 deaths annually worldwide. However, it also affects individuals with other forms of immunosuppression, including those undergoing immunosuppressive therapy, organ transplant recipients, patients with innate immunodeficiencies, and individuals with hematological disorders. The infection is caused mainly by Cryptococcus neoformans and Cryptococcus gattii,...
Sexually Transmitted Infections01:26

Sexually Transmitted Infections

Sexually transmitted infections (STIs) are diseases transmitted primarily through unsafe sexual interactions. Bacteria, viruses, or parasites cause them and can result in severe health complications if untreated.ChlamydiaThe bacterium Chlamydia trachomatis is responsible for the disease Chlamydia, the most common STI in the United States. This peculiar pathogen requires human cells to reproduce, residing intracellularly. The initial infection often goes unnoticed because it typically does not...
Assumptions of Survival Analysis01:15

Assumptions of Survival Analysis

Survival models analyze the time until one or more events occur, such as death in biological organisms or failure in mechanical systems. These models are widely used across fields like medicine, biology, engineering, and public health to study time-to-event phenomena. To ensure accurate results, survival analysis relies on key assumptions and careful study design.
Immunodeficiency Diseases01:25

Immunodeficiency Diseases

Immunodeficiency disorders are conditions in which the immune system's ability to fight infectious disease and cancer is compromised or entirely absent. The immune system comprises a complex network of cells, tissues, and organs that work together to protect the body from potentially harmful invaders. When this system is deficient or not functioning properly, it leaves the body susceptible to infections, diseases, or other complications.
There are three main causes of immunodeficiency disorders...