Relation of peripheral neuropathy to HIV treatment in four randomized clinical trials including didanosine

Clinical Therapeutics

Volumn 21, Issue 7, 1999, Pages 1182-1192

  Kelleher, Thomas ^a   Cross, Anne ^a   Dunkle, Lisa ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

Combined analysis; Didanosine; Peripheral neuropathy

Indexed keywords

DIDANOSINE; ZALCITABINE; ZIDOVUDINE;

ADOLESCENT; ADULT; AGED; ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; FEMALE; FOLLOW UP; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INCIDENCE; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; RISK FACTOR; SCORING SYSTEM;

EID: 0032810478     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/S0149-2918(00)80021-1     Document Type: Article

References (17)

1. 1. VIDEX® (didanosine) product information. In: Physicians' Desk Reference®. 51st ed. Montvale, NJ: Medical Economics; 1997:2980-2984.
2. 2. Rozencweig M, McLaren C, Beltengady M, et al. Overview of phase I trials of 2′,3′-dideoxyinosine (ddl) conducted on adult patients. Rev Infect Dis. 1990;12(Suppl 5):S570-S575.
3. 3. Pike IM, Nicaise C. The Didanosine Expanded Access Program: Safety analysis. Clin Infect Dis. 1993;16(Suppl 1):S63-S68.
4. 4. Schindzielorz A, Pike I, Daniels M, et al. Rates and risk factors for adverse events associated with didanosine in the Expanded Access Program. Clin Infect Dis. 1994;19:1076-1083.
5. 5. Kahn JO, Lagakos SW, Richman DD, et al. A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. NEJM. 1992;327:581-587.
6. 6. Spruance SL, Pavia AT, Peterson D, et al. Didanosine compared with continuation of zidovudine in HIV-infected patients with signs of clinical deterioration while receiving zidovudine: A randomized, double-blind clinical trial. Ann Intern Med. 1994; 120:360-368.
7. 7. Dolin R, Amato DA, Fischl MA, et al. Zidovudine compared with didanosine in patients with advanced HIV type 1 infection and little or no previous experience with zidovudine. Arch Intern Med. 1995;155: 961-974.
8. 8. Hammer SM, Katzenstein DA, Hughes MD, et al. A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. NEJM. 1996:335:1081-1090.
9. 9. Fauci AS, Braunwald E, Isselbacher KJ, et al, eds. Harrison's Principles of Internal Medicine. 14th ed. New York: McGraw-Hill; 1997.
10. 10. Fleiss JL. Assessing significance in a four-fold table. In: Statistical Methods for Rates and Proportions. New York: John Wiley & Sons; 1973:19-32.
11. 11. Kalbfleisch JD, Prentice RL. Estimation of the survivor function. In: The Statistical Analysis of Failure Time Data. New York: John Wiley & Sons; 1980:10-15.
12. 12. Kalbfleisch JD, Prentice RL. The proportional hazards model. In: The Statistical Analysis of Failure Time Data. New York: John Wiley & Sons; 1980:70-118.
13. 13. Ho DD, Rota TR, Schooley RT, et al. Isolation of HTLV-III from cerebrospinal fluid and neural tissues of patients with neurologic syndromes related to the acquired immunodeficiency syndrome. NEJM. 1985;313:1493-1497.
14. 14. de la Monte SM, Gabuzda DH, Ho DD, et al. Peripheral neuropathy in the acquired immunodeficiency syndrome. Ann Neurol. 1988;23:485-492.
15. 15. Chaisson RE, Volberding PA. Clinical manifestations of HIV infection. In: Mandell GL, Bennett JE, Dolin R, eds. Principles and Practice of Infectious Diseases. 4th ed. New York: Churchill Livingstone; 1995:1217-1253.
16. s6. Fuller GN. Cytomegalovirus and the peripheral nervous system in AIDS. J Acquired Immune Defic Syndr Hum Retrovirol. 1992;5(Suppl 1):S33-S36.
17. 17. Whitley RJ. Varicella-zoster viruz In: Mandell GL, Bennett JE, Dolin R, eds. Principles and Practice of Infectious Diseases. 4th ed. New York: Churchill Livingstone; 1995:1345-1351.