Body that evaluates treatments for HIV-infected children and adolescents and develops new approaches for the interruption of mother-to-infant transmission.

A disease prevalent throughout an entire country, continent or the whole world. See Endemic, Epidemic.

A method for the early detection of cancer and other abnormalities of the female genital tract, especially of the cervix.

Prevention education approach that utilizes HIV-experienced counselors to educate people living with HIV disease and to encourage them to take an active role in their treatment regimens and medical care.

Person with AIDS. Also known as PLWA, person living with AIDS.

Involve the initial introduction of an investigational new drug into humans. Phase I trials are closely monitored and may be conducted in patients or in healthy volunteers. The studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, safety, side effects associated with increasing doses, and if possible, early evidence of effectiveness. The trials also can include studies of structure-activity relationships, mechanisms of action in humans, use of the investigational drug as research tools to explore biological phenomena, or disease processes. The total number of patients included in Phase I studies varies but is generally in the range of 20 to 80. Sufficient information should be obtained in the trial to permit design of well-controlled, scientifically valid Phase II studies.

Include controlled clinical studies of effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study, and determination of common, short-term side effects and risks associated with the drug. Phase II studies are typically well controlled, closely monitored, and usually involve no more than several hundred patients.

Expanded controlled and uncontrolled studies. They are performed after preliminary evidence of drug effectiveness has been obtained. They are intended to gather additional information about effectiveness and safety needed to evaluate the overall benefit-risk relationship of the drug, and to provide an adequate basis for physician labeling. These studies usually include anywhere from several hundred to several thousand subjects.

Post-marketing studies, carried out after licensure of the drug. Generally, a Phase IV trial is a randomized, controlled trial that is designed to evaluate the long-term safety and efficacy of a drug for a given indication. Phase IV trials are important in evaluating AIDS drugs because many drugs for HIV infection have been given accelerated approval with small amounts of clinical data about the drugs' effectiveness.

People Living with HIV Disease

The total number of persons in a defined population living with a specific disease or condition at a given time (compared to incidence, which is the number of new cases).

The proportion of a population living at a given time with a condition or disease (compared to the incidence rate, which refers to new cases).

Prevention education approach aimed at those that are HIV+. Messages from other HIV+ individuals are used to raise awareness about passing the virus on to their partners.

An enzyme that triggers the breakdown of proteins. HIV's protease enzyme breaks apart long strands of viral protein into separate proteins constituting the viral core and the enzymes it contains. HIV protease acts as new virus particles are budding off a cell membrane.

A drug that binds to and blocks HIV protease from working, thus preventing the production of new functional viral particles.