HIV Infections — Effects of Highly Active Anti-Retroviral Therapy on Cardiovascular Health in Infants of HIV-Infected Mothers
Citation(s)
Al-Attar I, Orav EJ, Exil V, Vlach SA, Lipshultz SE Predictors of cardiac morbidity and related mortality in children with acquired immunodeficiency syndrome. J Am Coll Cardiol. 2003 May 7;41(9):1598-605.
Moylett EH, Hanson IC Mechanistic actions of the risks and adverse events associated with vaccine administration. J Allergy Clin Immunol. 2004 Nov;114(5):1010-20; quiz 1021. Review.
Nance CL, Shearer WT Is green tea good for HIV-1 infection? J Allergy Clin Immunol. 2003 Nov;112(5):851-3. Review.
Seeborg FO, Gay H, Schmiege LM 3rd, Bernard D, Shearer WT Immunoglobulin G kappa [IgG kappa] and IgG lambda paraproteinemia in a child with AIDS and response to highly active antiretroviral therapy. Clin Diagn Lab Immunol. 2005 Nov;12(11):1331-3.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
