Reporting and Evaluation of HIV-Related Clinical Endpoints in Two Multicenter International Clinical Trials

REFERENCES

• Lagakos SW. Surrogate markers in AIDS clinical trials: conceptual basis, validation, and uncertainties. Clin Infect Dis. 1993;16\(suppl 1):522–25.
   Google Scholar
• De Gruttola V, Fleming T, Lin DY, Coombs R. Perspective: validating surrogate markers- Are we being naive? J In-fect Dis. 1997;175:237-246.
   Google Scholar
• HIV Surrogate Marker Collaborative Group. Human immu-nodeficiency virus type 1 RNA level and CD4 count as prognostic markers and surrogate endpoints: a meta-analysis. AIDS Res Hum Retro viruses. 2000;16:1123–1133.
   PubMed Web of Science ®Google Scholar
• Concorde Coordinating Committee. Concorde: MRC/ ANRS randomised double-blind controlled trial of immedi-ate and deferred zidovudine in symptom-free HIV infection. Lancet. 1994;343:871–881.
   PubMed Web of Science ®Google Scholar
• El-Sadr W, Neaton J. Episodic CD4-guided use of ART is inferior to continuous therapy: results of the SMART study. Paper presented at: 13th Conference on Retroviruses and Opportunistic Infections; February 2006; Denver, CO. Ab-stract 106LB.
   Google Scholar
• Davey RT, Murphy RL, Graziano FM, et al. Immunologic and virologic effects of subcutaneous interleukin 2 in com-bination with antiretroviral therapy: a randomized con-trolled trial. JAMA. 2000;284:183–189.
   PubMed Web of Science ®Google Scholar
• Forum for Collaborative HIV Research. Immune-based therapies: a review of clinical endpoints used in trials of selected immunologic agents. HIV Clin Trials. 2002;3:58–88.
   PubMedGoogle Scholar
• Amato DA, Lagakos SW. Considerations in the selection of end points for AIDS clinical trials. J Acquir Immune Defic Syndr. 1990;3\(suppl 2):564–68.
   Google Scholar
• Green LA, Rhame FS, Price RW, et al. Experience with a cross-study endpoint review committee for AIDS clinical trials. AIDS. 1998;12:1983–1990.
   PubMed Web of Science ®Google Scholar
• Centers for Disease Control and Prevention. 1993 revised classification system for HIV infection and expanded sur-veillance case definition for AIDS among adolescents and adults. MMWR. 1992:41(RR-17):1–19.
   Google Scholar
• Neaton JD, Wentworth DN, Rhame F, et al. Considerations in choice of a clinical endpoint for AIDS clinical trials. Stat Med. 1994;13:2107–2125.
   PubMed Web of Science ®Google Scholar
• Moore RD, Chaisson RE. Natural history of opportunistic disease in an HIV-infected urban clinical cohort. Ann Intern Med. 1996;124:633–642.
   PubMed Web of Science ®Google Scholar
• Mocroft A, Youle M, Phillips AN, et al. The incidence of AIDS-defining illnesses in 4883 patients with human immu-nodeficiency virus infection. Arch Intern Med. 1998;158:491–497.
   PubMed Web of Science ®Google Scholar
• Supparatpinyo K, Khamwan C, Baosoung V, Nelson KE, Sirisanthana T. Disseminated Penicillium mameffei infec-tion in Southeast Asia. Lancet. 1994: 344:110–113.
   PubMed Web of Science ®Google Scholar
• Cooper DA, Gate!! JM, Kroon S, et al. Zidovudine in per-sons with asymptomatic HIV infection and CD4+ cell counts greater than 400 per cubic millimeter. N Engl J Med. 1993; 329:297–303.
   PubMed Web of Science ®Google Scholar
• Montaner JSG, Schechter MT, Rachlis A, et al. Didanosine compared with continued zidovudine therapy for HIV-in-fected patients with 200 to 500 CD4 cells/mm3. Ann Intern Med. 1995; 123:561–571.
   PubMed Web of Science ®Google Scholar
• Eisenbud R, Assmann SF, Kalish LA, et al. Differences in difficulty adjudicating clinical events in patients with ad-vanced HIV disease. J Acquir Immune Defic Syndr. 2001;28:43–46.
   PubMed Web of Science ®Google Scholar
• Levy Y, Mitsuyasu R, Tambusi G, et al. CD4 count in-creases in patients with CD4 counts of 50–300 treated with intermittent IL-2: immunologic results from the Study of IL-2 in Combination with Active Antiretroviral Therapy (SILCAAT) Trial. Paper presented at: Ninth European AIDS Conference; October 2003; Warsaw, Poland. Abstract F 14/3.
   Google Scholar
• Emery S, Abrams DI, Cooper DA, et al. The Evaluation of Subcutaneous Proleukin (interleukin-2) in a Randomized International Trial: rationale, design, and methods of ES-PRIT. Control Clin Trials. 200223: 198–220.
   Google Scholar
• Hughes CP, Berg L, Danziger WL, Coben LA, Martin RL. A new clinical scale for the staging of dementia. BrJ Psychia-try. 1982;140:566–572.
   PubMed Web of Science ®Google Scholar
• Price RW, Brew BJ. The AIDS dementia complex. J Infect 0is. 1988;158:1079–1083.
   PubMed Web of Science ®Google Scholar
• Rothman KJ. Modern Epidemiology. Boston: Little, Brown and Company;1986:84–89.
   Google Scholar
• Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: Greater preci-sion but with greater uncertainty? JAMA. 2003;289: 2554–2559.
   PubMed Web of Science ®Google Scholar
• Chi GYH. Some issues with composite endpoints in clinical trials. Fundam Clin Pharmacol. 2005;19:609–619.
   PubMed Web of Science ®Google Scholar
• Loannidis JPA, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA. 2001;285:437–443.
   PubMed Web of Science ®Google Scholar
• Reisler RB, Han C, Burman WJ, Tedaldi EM, Neaton JD. Grade 4 events are as important as AIDS events in the era of HAART. J Acquir Immune Defic Syndr. 2003;34:379–386.
   PubMed Web of Science ®Google Scholar
• Trotti A, Bentzen SM. The need for adverse effects report-ing standards in oncology clinical trials. J Clin Oncol. 2004;22:19–22.
   PubMed Web of Science ®Google Scholar
• Loannidis JPA, Evans SJW, Gotzsche PC, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141:781–788.
   PubMed Web of Science ®Google Scholar
• Juni P, Nartey L, Reichenbach S, et al. Risk of cardiovascu-lar events and rofecoxib: cumulative meta-analysis. Lan-cet. 2004;364:2021–2029.
   PubMed Web of Science ®Google Scholar