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What about clinical trials of HAART meds on children?
Oct 8, 2010

Dr. Henry - thank you for your prior response. My follow-up questions: Initially, meds were prescribed for children, based on clinical trials which only involved adults. Doses prescribed for HIV+ children were doses based on studies only involving adult response to meds / doses / etc. I know that now, there have clinical trials with children. I also know, however, there is a lot of debate, particularly in communities of color, where pharmaceutical companies offer gift certificates to toy stores, to obtain consent for children to participate in trials. What are the study results, and what are the ethical discussions regarding use of minor children (and often disproportionately children of color) in clinical trials? THANK YOU!

Response from Dr. Henry

You raise a lot of good questions/points. A good source of information may be the Pediatric AIDS Clinical Trials Group (the US NIH sponsored research group for clinical studies involving HIV+ children) web site. Many of the pills made of adults are difficult for children to swallow and are not clearly amendable to crushing or other ways to address the pill size issue. There are scores of studies that have been done by the PACTG, industry, and other research organizations on a wide range of HIV-related topics. KH

See below for information about the PACTG.

Pediatric AIDS Clinical Trials Group - PACTG Organization URL(s) broy@opsctr.s-3.com pactg.s-3.com External Link Other Contact Information

6101 Executive Boulevard Suite 350 Rockville, MD 20852

301-770-9276 (FAX) Description

The Pediatric AIDS Clinical Trials Group (PACTG) is the preeminent organization in the world for evaluating treatments for HIV-infected children and adolescents, and for developing new approaches for the interruption of mother-to-infant transmission. The PACTG, a joint effort of the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute for Child Health and Human Development (NICHD), encompasses the mission for HIV-infected pregnant women and children that the Adult AIDS Clinical Trial Group (AACTG), the Community Programs for Clinical Research on AIDS (CPCRA), the AIDS Vaccine Evaluation Group (AVEG), the Division of AIDS Treatment Research Initiative (DATRI), and the pharmaceutical industry-sponsored studies represent for HIV-infected adults.



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