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May 2, 2001

Outcomes of a Trial of HIV-1 Immunogen in Patients With HIV Infection

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;285(17):2191-2195. doi:10.1001/jama.285.17.2191

To the Editor: I was an investigator in the recently published HIV-1 Immunogen protocol.1 I was therefore surprised to see the results published without having had at least an opportunity to review the manuscript. The authors generically included the term 806 Investigator Team even though most of the participating investigators did not have any input into the article. In my experience, investigators who are involved in interinstitutional studies usually have the ability to offer comments and make suggestions before an article is submitted for publication. In this case, it appears that a roadblock was reached between the lead authors and the sponsoring company. According to the sponsor, the IRC, the authors refused to incorporate a cohort of patients that the company thought was of scientific merit (Ronald Moss, MD, vice president of Medical and Scientific Affairs, IRC, written communication, October 30, 2000). Arguments can be made for both sides in this debate and it is most unfortunate that a satisfactory conclusion was not obtained. Reviewers of the manuscript could have determined whether the added data were valuable enough to be included in the final publication. Additionally, I wonder why the authors did not request a complete listing of individual investigators and institutions involved in the trial. This information was obtainable from the sponsor.

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