Randomized trials stopped early for harm in HIV/AIDS: A systematic survey

HIV Clinical Trials

Volumn 7, Issue 1, 2006, Pages 24-33

  Mills, Edward ^a,b,c,d,e,j   Cooper, Curtis ^f   Wu, Ping ^g   Rachlis, Beth ^h   Singh, Sonal ^a,b,c,d,e   Guyatt, Gordon H ⁱ  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b JOHNS HOPKINS UNIVERSITY   (United States)

^c UNIVERSITY OF OXFORD   (United Kingdom)

^d University of Rhodes   (United States)

^e UNIVERSITY OF TORONTO   (Canada)

^f UNIVERSITY OF OTTAWA   (Canada)

^g LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^h UNIVERSITY OF BRITISH COLUMBIA   (Canada)

ⁱ MCMASTER UNIVERSITY   (Canada)

^j Centre for International Health and Human Rights Studies   (Canada)

more..

Author keywords

Harm; HIV; Randomized controlled trials; Research methodology; Stopping rules

Indexed keywords

ABACAVIR PLUS LAMIVUDINE PLUS ZIDOVUDINE; ALPHA INTERFERON; AMANTADINE; ANTIRETROVIRUS AGENT; CLARITHROMYCIN; CLINDAMYCIN; GRANULOCYTE COLONY STIMULATING FACTOR; HYDROXYUREA; NEVIRAPINE; PLACEBO; PYRIMETHAMINE; RETINOL; VALACICLOVIR;

ABSTRACT REPORT; ACQUIRED IMMUNE DEFICIENCY SYNDROME; ARTICLE; BRAIN DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DRUG DOSE REGIMEN; DRUG FATALITY; DRUG MONITORING; ENCEPHALITIS; FINANCIAL MANAGEMENT; HEALTH SURVEY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMATION PROCESSING; INFORMED CONSENT; INTERNET; LIVER FAILURE; MAJOR CLINICAL STUDY; MEDICAL DECISION MAKING; MEDICAL LITERATURE; MULTICENTER STUDY; PATIENT ADVOCACY; POPULATION RESEARCH; PRACTICE GUIDELINE; PREVALENCE; PRIORITY JOURNAL; PUBLICATION; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SAMPLE SIZE; STEVENS JOHNSON SYNDROME; SYSTEMATIC REVIEW; TREATMENT OUTCOME; TREATMENT PLANNING; TREATMENT WITHDRAWAL; VIRUS TRANSMISSION;

ANTI-HIV AGENTS; CLINICAL TRIALS DATA MONITORING COMMITTEES; HIV INFECTIONS; HUMANS; RANDOMIZED CONTROLLED TRIALS;

EID: 33646558562     PISSN: 15284336     EISSN: None     Source Type: Journal    
DOI: 10.1310/FEED-6T8U-0BUG-6HQH     Document Type: Article

References (41)

1. Pocock SJ. When to stop a clinical trial. BMJ. 1992;305:235-240.
2. Pocock S, White I. Trials stopped early: too good to be true? Lancet. 1999;353:943-944.
3. Cannistra SA. The ethics of early stopping rules: who is protecting whom? J Clin Oncol 2004;22:1542-1545.
4. Schulz KF, Grimes DA. Multiplicity in randomised trials II: subgroup and interim analyses. Lancet. 2005;365:1657-1661.
5. Fauci AS. HIV and AIDS: 20 years of science. Nat Med. 2003;9:839-843.
6. Moher D, Schulz KF, Altman D. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001;285:1987-1991.
7. Montori VM, Devereaux PJ, Adhikari NK, et al. Randomized trials stopped early for benefit: a systematic survey of the literature. JAMA. In press.
8. Ananworanich J, Nuesch R, Le Braz M, at al. Failures of 1 week on, 1 week off antiretroviral therapies in a randomized trial. AIDS. 2003;1 7:F33-37.
9. Dybul M, Nies-Kraske E, Daucher M, et al. Long-cycle structured intermittent versus continuous highly active antiretroviral therapy for the treatment of chronic infection with human immunodeficiency virus: effects on drug toxicity and on immunologic and virologic parameters. J Infect Dis. 2003;188:388-396.
10. Englund JA, Baker CJ, Raskino C, et al. Zidovudine, didanosine, or both as the initial treatment for symptomatic HIV-infected children. AIDS Clinical Trials Group (ACTG) Study 152 Team. N Engl J Med. 1997;336:1704-1712.
11. Havlir DV, Gilbert PB, Bennett K, et al. Effects of treatment intensification with hydroxyurea in HIV-infected patients with virologic suppression. AIDS. 2001;15:1379-1388.
12. Havlir DV, Marschner IC, Hirsch MS, et al. Maintenance antiretroviral therapies in HIV infected patients with undetectable plasma HIV RNA after triple-drug therapy. AIDS Clinical Trials Group Study 343 Team. N Engl J Med. 1998;339:1261-1268.
13. Pialoux G, Raffi F, Brun-Vezinet F, et al. A randomized trial of three maintenance regimens given after three months of induction therapy with zidovudine, lamivudine, and indinavir in previously untreated HIV-1-infected patients. Trilege (Agence Nationale de Recherches sur le SIDA 072) Study Team. N Engl J Med. 1998;339:1269-1276.
14. Reijers MH, Weverling GJ, Jurriaans S, et al. Maintenance therapy after quadruple induction therapy in HIV-1 infected individuals: Amsterdam Duration of Antiretroviral Medication (ADAM) study. Lancet. 1998;352:185-190.
15. Lallemant M, Jourdain G, Le Coeur S, et al. A trial of shortened zidovudine regimens to prevent mother-to-child transmission of human immunodeficiency virus type 1. Perinatal HIV Prevention Trial (Thailand) Investigators. N Engl J Med. 2000;343:982-991.
16. Salmon-Ceron D, Fontbonne A, Saba J, et al. Lower survival in AIDS patients receiving dapsone compared with aerosolized pentamidine for secondary prophylaxis of Pneumocystis carinii pneumonia. Study Group. J Infect Dis. 1995;172:656-664.
17. Ananworanich J, et al. (for the HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT). A randomized trial of continuous, CD4-guided and one week on - one week off HAART in 74 patients with chronic HIV infection: week 108 results. In: Program and abstracts of the 15th International AIDS Conference; July 11-16, 2004; Bangkok, Thailand. Abstract WeOrB1283 (oral).
18. Clumeck N, Mundere J, Kabeya K. MIRO: a randomized trial of maintenance therapy with or without protease inhibitors after 4 months of triple or quadruple induction therapy. In: Program and abstracts of the 6th Conference on Retroviruses and Opportunistic Infections; 1999, Chicago. Abstract 627.
19. Aladdin H, Ullum H, Katzenstein T, Gerstoft J, Skinhoj P, Klarlund Pedersen B. Immunological and virological changes in antiretroviral naive human immunodeficiency virus infected patients randomized to G-CSF or placebo simultaneously with initiation of HAART. Scand J Immunol. 2000;51:520-525.
20. Cohn DL, Fisher EJ, Peng GT, et al. A prospective randomized trial of four three-drug regimens in the treatment of disseminated Mycobacterium avium complex disease in AIDS patients: excess mortality associated with high-dose clarithromycin. Terry Beirn Community Programs for Clinical Research on AIDS. Clin Infect Dis. 1999;29:125-133.
21. Blanckenberg DH, Wood R, Horban A, et al. Evaluation of nevirapine and/ or hydroxyurea with nucleoside reverse transcriptase inhibitors in treatment-naive HIV-1-infected subjects. AIDS. 2004;18:631-640.
22. Hitti J, Frenkel LM, Stek AM. Maternal toxicity with continuous nevirapine in pregnancy: results from PACTG 1022. J Acquir Immune Defic Syndr. 2004;36:772-776.
23. Jacobson MA, Besch CL, Child C, et al. Toxicity of clindamycin as prophylaxis for AIDS-associated toxoplasmic encephalitis. Community Programs for Clinical Research on AIDS. Lancet. 1992;339:333-334.
24. Jacobson MA, Besch CL, Child C, et al. Primary prophylaxis with pyrimethamine for toxoplasmic encephalitis in patients with advanced human immunodeficiency virus disease: results of a randomized trial. Terry Beim Community Programs for Clinical Research on AIDS. J Infect Dis. 1994;169:384-394.
25. Maggiolo F, Ripamonti D, Callegaro A, Gregis G, Quinzan G, Suter F. Quadruple-drug induction HAART in advanced HIV infection. HIV Clin Trials. 2005;6:1-4.
26. Fawzi WW, Msamanga GI, Hunter D, et al. Randomized trial of vitamin supplements in relation to transmission of HIV-1 through breastfeeding and early child mortality. AIDS. 2002;16:1935-1944.
27. Feinberg JE, Hurwitz S, Cooper D, et al. A randomized, double-blind trial of valaciclovir prophylaxis for cytomegalovirus disease in patients with advanced human immunodeficiency virus infection. AIDS Clinical Trials Group Protocol 204/Glaxo Wellcome 123-014 International CMV Prophylaxis Study Group. J Infect Dis. 1998;177:48-56.
28. Sax H, Friedl A, Renner E, Steuerwald MH, Weber R. Pilot study of interferon-alpha with and without amantadine for the treatment of hepatitis C in HIV coinfected individuals on antiretroviral therapy. Infection. 2001;29:267-270.
29. Contopoulos-Ioannidis DG, Ntzani E, Ioannidis JP. Translation of highly promising basic science research into clinical applications. Am J Med. 2003;114:477-484.
30. Fergusson D, Doucette S, Glass KC, Shapiro S, Healy D, Hebert P, Hutton B. Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials. BMJ. 2005;330:396.
31. Fisher CB. Public health. Clinical trials results databases: unanswered questions. Science. 2006;311:180-181.
32. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657-662.
33. Montori VM, Devereaux PJ, Adhikari NK, et al. Randomized trials stopped early for benefit: a systematic review. JAMA. 2005;294:2203-2209.
34. Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. A survey of three medical journals. N Engl J Med. 1987;317:426-432.
35. Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intem Med. 2004; 141:781-788.
36. Mills E, Loke YK, Wu P, Montori VM, Perri D, Moher D, Guyatt G. Determining the reporting quality of RCTs in clinical pharmacology. Br J Clin Pharmacol. 2004;58:61-65.
37. Mills E, Wu P, Gagnier J, Heels-Ansdell D, Montori VM. An analysis of general medical and specialist journals that endorse CONSORT found that reporting was not enforced consistently. J Clin Epidemiol. 2005;58:662-667.
38. Mills EJ, Wu P, Gagnier J, Devereaux PJ. The quality of randomized trial reporting in leading medical journals since the revised CONSORT statement. Contemp Clin Trials. 2005;26:480-487.
39. Slutsky AS, Lavery JV. Data safety and monitoring boards. N Engl J Med. 2004;350:1143-1147.
40. Mills EJ, Wu P, Seely D, Guyatt GH. Vitamin supplementation for prevention of mother-to-child transmission of HIV and pre-term delivery: a systematic review of randomized trial including more than 2800 women. AIDS Res Ther. 2005;2:4.
41. Dixon DO, Lagakos SW. Should data and safety monitoring boards share confidential interim data? Control Clin Trials. 2000;21:1-6; discussion 54-55.