Zidovudine Compared With Didanosine in Patients With Advanced HIV Type I Infection and Little or No Previous Experience With Zidovudine

Archives of Internal Medicine

Volumn 155, Issue 9, 1995, Pages 961-974

  Dolin, Raphael ^a   Amato, David A ^b,n   Fischl, Margaret A ^c   Pettinelli, Carla ^d   Beltangady, Mohan ^e   Liou, Song Heng ^b   Brown, Michael J ^e   Cross, Anne P ^e   Hirsch, Martin S ^f   Hardy, W David ^g   Mildvan, Donna ^h   Blair, Donald C ⁱ   Powderly, William G ^j   Para, Michael F ^k   Fife, Kenneth H ^l   Steigbigel, Roy T ^m   Smaldone, Laurie ^e  

^a UNIVERSITY OF ROCHESTER   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^d NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^e BRISTOL MYERS SQUIBB PHARMACEUTICAL RESEARCH INSTITUTE   (United States)

^f MASSACHUSETTS GENERAL HOSPITAL   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h BETH ISRAEL MEDICAL CENTER   (United States)

ⁱ STATE UNIVERSITY OF NEW YORK   (United States)

^j WASHINGTON UNIVERSITY   (United States)

^k THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

^l INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^m STONY BROOK UNIVERSITY   (United States)

ⁿ Data Research and Analysis   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DIDANOSINE; ZIDOVUDINE;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FEMALE; GRANULOCYTOPENIA; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; ORAL DRUG ADMINISTRATION; PANCREATITIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ADULT; AIDS-RELATED OPPORTUNISTIC INFECTIONS; CD4 LYMPHOCYTE COUNT; DIDANOSINE; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; PATIENT COMPLIANCE; SEVERITY OF ILLNESS INDEX; SURVIVAL ANALYSIS; TREATMENT OUTCOME; ZIDOVUDINE;

EID: 0028906281     PISSN: 00039926     EISSN: 15383679     Source Type: Journal    
DOI: 10.1001/archinte.1995.00430090111012     Document Type: Article

References (30)

1. Mitsuya H, Broder S. Inhibition of the in vitro infectivity and cytopathic effect of human T-lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/ LAV) by 2′,3′-dideoxynucleosides. Proc Natl Acad Sci USA. 1986;83:1911-1915.
2. 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;317:185-191.
3. Fischl MA, Richman DD, Hansen N, et al. The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection: a double-blind, placebo-controlled trial. Ann Intern Med. 1990;112:727-737.
4. Hamilton JD, Hartigan PM, Simberkoff MS, et al. A controlled trial of early versus late treatment with zidovudine in symptomatic human immunodeficiency virus infection: results of the Veterans Affairs Cooperative Study. N Engl J Med. 1992;326:437-443.
5. 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. N Engl J Med. 1990;322:941-949.
6. Larder BA, Darby G, Richman DD. HIV with reduced sensitivity to zidovudine (AZT) isolated during prolonged therapy. Science. 1989;243:1731-1734.
7. Rooke R, Tremblay M, Soudeyns H, et al. Isolation of drug resistant variants of HIV-1 from patients on long-term zidovudine therapy. AIDS. 1989;3:411-415.
8. Richman DD, Grimes JM, Lagakos SW. Effect of stage of disease and drug dose on zidovudine susceptibilities of isolates of human immunodeficiency virus. J Acquir Immune Defic Syndr. 1990;3:743-746.
9. Yarchoan R, Mitsuya H, Thomas RV, et al. In vivo activity against HIV and favorable toxicity profile of 2′,3′-dideoxyinosine. Science. 1989;245:412-415.
10. Cooley TP, Kunches IM, Saunders CA, et al. Once-daily administration of 2′,3′-dideoxyinosine (didanosine) in patients with the acquired immunodeficiency syndrome or AIDS-related complex: results of a phase I trial. N Engl J Med. 1990;322:1340-1345.
11. Lambert JS, Seidlin M, Reichman RC, et al. 2′,-3′-dideoxyinosine (didanosine) in patients with the acquired immunodeficiency syndrome or AIDS-related complex: a phase I trial. N Engl J Med. 1990;322:1333-1340.
12. Yarchoan R, Pluda JM, Thomas RV, et al. Long-term toxicity/activity profile of 2′,3′-dideoxyinosine in AIDS or AIDS-related complex. Lancet. 1990;336:526-529.
13. Kahn JO, Lagakos SW, Richman DD, Cross A, et al. A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. N Engl J Med. 1992;327:581-587.
14. Richman DD, Fischl MA, Grieco MH, et al. The toxicity 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;317:192-197.
15. Connolly KJ, Allan JD, Fitch H, et al. Phase I study of 2′-3′-dideoxyinosine administered orally twice daily to patients with AIDS or AIDS-related complex and hematologic intolerance to zidovudine. Am J Med. 1990;91:471-478.
16. Kahn J. New developments in the clinical use of didanosine. J Acquir Immune Defic Syndr. 1993;6(suppl 1):647-650.
17. Schacter LP, Rozencweig M, Beltangady M, et al. Effects of therapy with didanosine on hematologic parameters in patients with advanced human immunodeficiency virus disease. Blood. 1992:80:2969-2976.
18. Zelen M. The randomization and stratification of patients to clinical trials. J Chronic Dis. 1974;27:365-375.
19. Revision of the CDC surveillance case definition for acquired immunodeficiency syndrome. MMWR Morb Mortal Wkly Rep. 1987;36(suppl):3S-15S.
20. Price RW, Brew BJ. The AIDS dementia complex. J Infect Dis. 1988;158:1079-1083.
21. Knupp CA, Stancato FA, Papp EA, Barbahiya RH. Quantitation of didanosine in human plasma and urine by high-performance liquid chromatography. J Chromatogr. 1990;533:282-290.
22. Kaplan EL, Meier P. Non parametric estimation from incomplete observations. JAm Stat Assoc. 1958;53:457-481.
23. Cox DR. Regression models and life tables. J R Stat Soc B. 1972;34:187-220.
24. Spruance SL, Pavia AT, Peterson D, Berry A, et al. Didanosine compared with continuation of zidovudine in HIV-infected patients with signs of clinical deterioration while receiving zidovudine. Ann Intern Med. 1994;120:360-368.
25. Seidlin M, Lambert JS, Dolin R, Valentine FT. Pancreatitis and pancreatic dysfunction in patients taking dideoxyinosine. AIDS. 1992;6:831-835.
26. Tersmette M, Lange J, deGoede R, et al. Association between biological properties of human immunodeficiency virus variants and risk for AIDS and AIDS mortality. Lancet. 1989;1:983-985.
27. Koot M, Vos AHV, Keet RPM, et al. HIV-1 biological phenotype in long-term infected individuals evaluated with an MT-2 cocultivation assay. AIDS. 1992; 6:49-54.
28. Richman DD, Guatelli, JC, Grimes J, Tsiatis A, Gingeras T. Detection of mutations associated with zidovudine resistance in human immunodeficiency virus by use of the polymerase chain reaction. J Infect Dis. 1991;164:1075-1081.
29. Kozal MJ, Shafer RW, Winters MA, Katzenstein DA, Merigan TC. A mutation in human immunodeficiency virus reverse transcriptase and decline in CD4 lymphocyte numbers in long-term zidovudine recipients. J Infect Dis. 1993;167: 526-532.
30. Schnittman SM, Greenhouse JJ, Psallidopoulos MC, et al. Increasing viral burden in CD4+ T cells from patients with human immunodeficiency virus (HIV) infection reflects rapidly progressive immunosuppression and clinical disease. Ann Intern Med. 1990;113:438-443.