Double-blind placebo-controlled pilot trial of acemannan in advanced human immunodeficiency virus disease

Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology

Volumn 12, Issue 2, 1996, Pages 153-157

  Montaner, Julio S G ^a   Gill, John ^b   Singer, Joel ^b   Raboud, Janet ^b   Arseneau, Rie ^b   McLean, Brian D ^b   Schechter, Martin T ^b   Ruedy, John ^b  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b NONE

Author keywords

Acemannan; Didanosine; Pharmacokinetics; Surrogate markers; Zidovudine

Indexed keywords

ACEMANNAN; ANTIGEN P24; DIDANOSINE; ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADOLESCENT; ADULT; AGED; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LEUKOCYTE COUNT; MALE; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

HUMAN IMMUNODEFICIENCY VIRUS;

EID: 0029950103     PISSN: 10779450     EISSN: None     Source Type: Journal    
DOI: 10.1097/00042560-199606010-00008     Document Type: Article

References (16)

1. Womble D, Helderman JH. Enhancement of alloresponsiveness of human lymphocytes by acemannan. Int J Immunopharmacol 1988;10:967-74.
2. Kahlon JB, Kemp MC, Carpenter RH, et al. Inhibition of AIDS virus replication by acemannan in vitro. Mol Biother 1991;3:127-35.
3. Sheets MA, Unger BA, Giggleman GF, Tizard IR. Studies of the effect of acemannan on retrovirus infections: clinical stabilization of feline leukemia virus-infected cats. Mol Biother 1991;3:41-5.
4. Hunt T, Holmes G, Carpenter R, McAnalley B, Helderman JH. Multiple dose parallel group and tolerance study of acemannan in normal male volunteers, Report no. 9002. Irvington, TX: Carrington Laboratories, 1988.
5. Weerts D, De Wit S, Gerard M, Rahir F, Janckheere J, Clumeck N. A phase II study of Carrisyn (C) (acemannan) alone and with AZT among symptomatic and asymptomatic HIV patients (P). [Abstract S.B. 469] Sixth International Conference on AIDS, San Francisco, June 1990.
6. Kahn JO, Lagakos SW, Richman DD, et al. A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. N Engl J Med 1992;327:581-7.
7. Hollinger FB, Bremer JW, Myers LE, et al. ACTG Virology Laboratories. Standardization of sensitive human immunodeficiency virus co-culture procedures and establishment of a multicentre quality assurance program for the AIDS Clinical Trials Group. J Clin Microbiol 1992;50:1787-94.
8. Gelmon K, Fanning M, Falutz J, et al. Nature, time course and dose dependence of zidovudine related side effects. Results from the Multicentre Canadian Azidothymidine Trial. AIDS 1989;3:555-61.
9. ZDV-Trac 1251 RIA Kit: for the determination of ZDV, AZT in serum or plasma. Catalog no. 23100. INCSTAR, Stillwater, MN, U.S.A. December, 1991.
10. Montaner JSG, Singer J, Schechter MT, et al. Clinical correlates of in vitro HIV-1 resistance of zidovudine. Results of the Multicentre Canadian AZT Trial. AIDS 1993;7:189-96.
11. Fischl MA, Richman DD, Grieco MH, et al. The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. A double-blind, placebo-controlled trial. N Engl J Med 1987;317:185-91.
12. Volberding PA, Lagakos SW, Koch MA, et al. Zidovudine in asymptomatic human immunodeficiency virus infection. A controlled trial in persons with fewer than 500 CD4 positive cells per cubic millimeter. The AIDS Clinical Trials Group of NIAID. N Engl J Med 1990;322:941-9.
13. Dawson JD, Lagakos SW. Analyzing laboratory marker changes in AIDS clinical trials. J Acquir Immune Defic Syndr 1991;4:667-76.
14. Concorde Coordinating Committee. Concorde: MRC/ANRS randomized double-blind controlled trial of immediate and deferred zidovudine in symptom-free HIV infection. Lancet 1994;343:871-81.
15. Raboud J, Montaner JSG, Thorne A, et al. Impact of missing data due to dropouts on estimates of the treatment effect in a randomized trial of antiretroviral therapy for HIV infected individuals. J Acquir Immune Defic Syndr Hum Retrovirol 1996;12:46-55.
16. 3. A double-blind, randomized, controlled trial. Ann Intern Med 1995;123:561-71.