Reporting and evaluaton of HIV-related clinical endpoints in two multicenter international clinical trials

Alan R. Lifson, Frank S. Rhame, Waldo H. Belloso, Ulrik B. Dragsted, Wafaa M. El-Sadr, Jose M. Gatell, Jennifer F. Hoy, Eric A. Krum, Ray Nelson, Court Pedersen, Sarah L. Pett, Richard T. Davey, James Neaton, Donald Abrams, Pedro Cahn, Bonaventura Clotet, David Cooper, Janet Darbyshire, Lehrman Sandra, Sean Emery & 9 others Ulrich Hengge, H. Clifford Lane, Joep Lange, Guido Levy, Yves Levy, Jens Lundgren, Ron Mitsuyasu, Jean Pierre Routy, Giuseppe Tambussi

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Purpose: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. Method: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure for adjudication of differences of opinion between reviewers. Results: Of 473 events reported through May 1, 2006, 28% were judged by an ERC to meet "confirmed" criteria and 38% to meet "probable" criteria; 34% were classified "does not meet criteria." For diseases with >5 case reports, the proportion accepted as either "confirmed" or "probable" events was highest for cervical cancer (100%), non-Hodgkin's lymphoma (88%), cryptococcosis (82%), and cryptosporidiosis (80%) and was lowest for HIV encephalopathy (25%), HIV wasting syndrome (33%), and multidermatomal herpes zoster (35%). 25% of cases required adjudication between reviewers before diagnostic certainty was assigned. Conclusion: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation by independent blinded reviewers, and procedures for adjudication.

Original languageEnglish
Pages (from-to)125-141
Number of pages17
JournalHIV Clinical Trials
Volume7
Issue number3
DOIs
Publication statusPublished - May 2006

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Clinical Trials
HIV
Disease Progression
Advisory Committees
HIV Wasting Syndrome
AIDS Dementia Complex
Cryptosporidiosis
Cryptococcosis
Phase III Clinical Trials
Herpes Zoster
Uterine Cervical Neoplasms
Documentation
Non-Hodgkin's Lymphoma
Interleukin-2
Therapeutics

Keywords

  • Clinical endpoints
  • Clinical trials
  • Human immunodeficiency virus

ASJC Scopus subject areas

  • Virology
  • Immunology

Cite this

Reporting and evaluaton of HIV-related clinical endpoints in two multicenter international clinical trials. / Lifson, Alan R.; Rhame, Frank S.; Belloso, Waldo H.; Dragsted, Ulrik B.; El-Sadr, Wafaa M.; Gatell, Jose M.; Hoy, Jennifer F.; Krum, Eric A.; Nelson, Ray; Pedersen, Court; Pett, Sarah L.; Davey, Richard T.; Neaton, James; Abrams, Donald; Cahn, Pedro; Clotet, Bonaventura; Cooper, David; Darbyshire, Janet; Sandra, Lehrman; Emery, Sean; Hengge, Ulrich; Lane, H. Clifford; Lange, Joep; Levy, Guido; Levy, Yves; Lundgren, Jens; Mitsuyasu, Ron; Routy, Jean Pierre; Tambussi, Giuseppe.

In: HIV Clinical Trials, Vol. 7, No. 3, 05.2006, p. 125-141.

Research output: Contribution to journalArticle

Lifson, AR, Rhame, FS, Belloso, WH, Dragsted, UB, El-Sadr, WM, Gatell, JM, Hoy, JF, Krum, EA, Nelson, R, Pedersen, C, Pett, SL, Davey, RT, Neaton, J, Abrams, D, Cahn, P, Clotet, B, Cooper, D, Darbyshire, J, Sandra, L, Emery, S, Hengge, U, Lane, HC, Lange, J, Levy, G, Levy, Y, Lundgren, J, Mitsuyasu, R, Routy, JP & Tambussi, G 2006, 'Reporting and evaluaton of HIV-related clinical endpoints in two multicenter international clinical trials', HIV Clinical Trials, vol. 7, no. 3, pp. 125-141. https://doi.org/10.1310/7MER-XFA7-1762-E2WR
Lifson, Alan R. ; Rhame, Frank S. ; Belloso, Waldo H. ; Dragsted, Ulrik B. ; El-Sadr, Wafaa M. ; Gatell, Jose M. ; Hoy, Jennifer F. ; Krum, Eric A. ; Nelson, Ray ; Pedersen, Court ; Pett, Sarah L. ; Davey, Richard T. ; Neaton, James ; Abrams, Donald ; Cahn, Pedro ; Clotet, Bonaventura ; Cooper, David ; Darbyshire, Janet ; Sandra, Lehrman ; Emery, Sean ; Hengge, Ulrich ; Lane, H. Clifford ; Lange, Joep ; Levy, Guido ; Levy, Yves ; Lundgren, Jens ; Mitsuyasu, Ron ; Routy, Jean Pierre ; Tambussi, Giuseppe. / Reporting and evaluaton of HIV-related clinical endpoints in two multicenter international clinical trials. In: HIV Clinical Trials. 2006 ; Vol. 7, No. 3. pp. 125-141.
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AU - Lifson, Alan R.

AU - Rhame, Frank S.

AU - Belloso, Waldo H.

AU - Dragsted, Ulrik B.

AU - El-Sadr, Wafaa M.

AU - Gatell, Jose M.

AU - Hoy, Jennifer F.

AU - Krum, Eric A.

AU - Nelson, Ray

AU - Pedersen, Court

AU - Pett, Sarah L.

AU - Davey, Richard T.

AU - Neaton, James

AU - Abrams, Donald

AU - Cahn, Pedro

AU - Clotet, Bonaventura

AU - Cooper, David

AU - Darbyshire, Janet

AU - Sandra, Lehrman

AU - Emery, Sean

AU - Hengge, Ulrich

AU - Lane, H. Clifford

AU - Lange, Joep

AU - Levy, Guido

AU - Levy, Yves

AU - Lundgren, Jens

AU - Mitsuyasu, Ron

AU - Routy, Jean Pierre

AU - Tambussi, Giuseppe

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N2 - Purpose: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. Method: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression and death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure for adjudication of differences of opinion between reviewers. Results: Of 473 events reported through May 1, 2006, 28% were judged by an ERC to meet "confirmed" criteria and 38% to meet "probable" criteria; 34% were classified "does not meet criteria." For diseases with >5 case reports, the proportion accepted as either "confirmed" or "probable" events was highest for cervical cancer (100%), non-Hodgkin's lymphoma (88%), cryptococcosis (82%), and cryptosporidiosis (80%) and was lowest for HIV encephalopathy (25%), HIV wasting syndrome (33%), and multidermatomal herpes zoster (35%). 25% of cases required adjudication between reviewers before diagnostic certainty was assigned. Conclusion: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation by independent blinded reviewers, and procedures for adjudication.

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