HIV — Bioequivalence Study of Pediatric Formulations to Treat HIV Infection
Citation(s)
1 WHO UNAIDS and UNESCO 2010. Towards Universal Access: Scaling up priority HIV/AIDS interventions in the health sector: Progress Report 2010. p1-150. Accessed May 14, 2011, at http://whqlibdoc.who.int/publications/2010/9789241500395_eng.pdf 2. Ellis JC, L'homme R, Ewings FM, Mulenga V, Bell F, Chileshe R, Molyneux E, Abernethy J, van Oosterhout JJG, Chintu C 2007. Nevirapine concentrations in HIV-infected children treated with divided fixed-dose combination antiretroviral tablets in Malawi and Zambia Antivir Ther (Lond ) 12:253-260. 3. Kashuba AD, Swanstrom RI 2010. Pharmacokinetics of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian children. Antivir Ther (Lond ) 15:83-90.
Phase I Three-way Crossover Bioequivalence Study of Pediatric Formulations of Lamivudine/Zidovudine/Nevirapine Using Healthy Adult Volunteers
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.
