A randomized pilot study of alternating or simultaneous Zidovudine and Didanosine Therapy in Patients with Symptomatic Human Immunodeficiency Virus Infection

Journal of Infectious Diseases

Volumn 169, Issue 1, 1994, Pages 9-17

  Yarchoan, Robert ^a   Lietzau, Jill A ^a   Nguyen, Bach Yen ^a   Brawley, Otis W ^a   Pluda, James M ^a   Saville, M Wayne ^a   Wyvill, Kathleen M ^a   Steinberg, Seth M ^a   Agbaria, Riad ^a   Mitsuya, Hiroaki ^a   Broder, Samuel ^a  

^a Laboratory of Medicinal Chemistry   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BILIRUBIN; CD4 ANTIGEN; DIDANOSINE; ZIDOVUDINE;

ANEMIA; ARTICLE; BILIRUBIN BLOOD LEVEL; CLINICAL FEATURE; DRUG EFFICACY; FEMALE; GRANULOCYTOPENIA; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERAMYLASEMIA; LACTIC ACIDOSIS; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; PANCREATITIS; PRIORITY JOURNAL; THROMBOCYTOPENIA; TREATMENT PLANNING; WEIGHT GAIN;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AIDS-RELATED OPPORTUNISTIC INFECTIONS; BETA 2-MICROGLOBULIN; BODY WEIGHT; CD4-POSITIVE T-LYMPHOCYTES; COMPARATIVE STUDY; DIDANOSINE; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HIV CORE PROTEIN P24; HIV INFECTIONS; HUMAN; LEUKOCYTE COUNT; MALE; MIDDLE AGE; PANCREATITIS; PILOT PROJECTS; ZIDOVUDINE;

EID: 0028010789     PISSN: 00221899     EISSN: 15376613     Source Type: Journal    
DOI: 10.1093/infdis/169.1.9     Document Type: Article

References (47)

1. Mitsuya H. Weinhold KJ. Furman PA, et al. 3'-a/ido-3'-deo\yihvrni- dine (BW A509U): An antiviral agent that inhibits the infectivity and cytopathic effect of human T-lymphotropic virus type III/lymphadenopathy-associated virus in vitro. Proc Natl Acad Sci USA 1985;82:7096-100.
2. Mitsuya H. BroderS. Inhibition of the in vitro infectivity and cytopathic effect of human T-lymphotropic virus type Ifl/lymphadenopathy-associated virus (HTLV-1II/LAV) by 2', 3’-dideoxynucleosides. Proc Natl Acad Sci USA 1986;83:1911-5.
3. Yarchoan R, Klecker RW, Weinhold KJ, et al. Administration of 3'- azido-3'-deoxythymidine, an inhibitorofHTLV-Hl/LAV replication, to patients with AIDS or AIDS-related complex. Lancet 1986; 1:575-80.
4. Fischl MA, Richman DD, Grieco MH, et al. The efficacy of azidothy-midine (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.
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;322:941-9.
6. Fischl M, 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 I (HIV) infection. A double-blind. placebo controlled trial. Ann Intern Med 1990; 112:727 -37.
7. Yarchoan R, Mitsuya H, Thomas RV, et al. In vivo activity against HIV and favorable toxicity profile of 2', 3'-dideoxyinosine. Science 1989;245:412-5.
8. Lambert JS. Seidlin M, Reichman RC, et al. 2\3'-dideoxyinosine (ddl) in patients with the acquired immunodeficiency syndrome or the AIDS-related complex. A phase 1 trial. N Engl J Med 1990; 322:1333-40.
9. Cooley TP, Kunches LM, Saunders CA. et al. Once-daily administration of2', 3'-dideoxyinosine (ddl) in patients with the acquired immunodeficiency syndrome or AIDS-related complex. N Engl J Med 1990;322:1430-45.
10. 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.
11. Richman DD, Fischl MA, Grieco MH, et al. The toxicity ofazidothy-midine (AZT) in the treatment of patients with AIDS and AlDS-re-lated complex: A double-blind, placebo-controlled trial. N Engl J Med 1987;317:192-7.
12. Yarchoan R, Perno CF, Thomas RV, et al. Phase I studies of 2’.3'-dideoxycytidine in severe human immunodeficiency virus infection as a single agent and alternating with zidovudine (AZT). Lancet 1988;1:76-81.
13. Merigan TC, Skowron G, Bozzette SA, et al. Circulating p24 antigen levels and responses to dideoxycytidine in human immunodeficiency virus (HIV) infections. Ann Intern Med 1989;110:189-94.
14. Larder BA. Kemp SD. Multiple mutations in HIV-1 reverse transcriptase confer high-level resistance to zidovudine (AZT). Science 1989:246:1155-8.
15. Richman DD, Grimes J, Lagakos S. Effect of stage of disease and drug dose on zidovudine susceptibilities of isolates of human immunodeficiency virus. J Acquir Immune Defic Syndr 1990;3:743-6.
16. St Clair MH, Martin JL, Tudor-Williams G, et al. Resistance to ddl and sensitivity to AZT induced by a mutation in HI V-1 reverse transcriptase. Science 1991:253:1557-9.
17. Shirasaka T, Yarchoan R, O'Brien MC, et al. Changes in drug-sensiti-vity of human immunodeficiency virus type 1 during therapy with azidothymidine. dideoxycytidine. or dideoxyinosine: An in vitro comparative study. Proc Natl Acad Sci USA 1993;90:562-6.
18. Crofton J. Tuberculosis undefeated. Br Med J 1960;2:679-87.
19. Fox W. The chemotherapy of pulmonary tuberculosis: A review. Chest 1979;76S:785-96.
20. DeVita VT, Serpick AA, Carbone PP. Combination therapy in the treatment of advanced Hodgkin’s disease. Ann Intern Med 1970;73:891-5.
21. Kennedy BJ, Bloomfield CD, Kiang DT, Vosika G, Peterson BA, Theo-logides A. Combination versus successive single agent chemotherapy in lymphocytic lymphoma. Cancer 1978;41:23-8.
22. Skowron G, Bozzette SA, Lim L, et al. Alternating and intermittent regimens of zidovudine and dideoxycytidine in patients with AIDS or AIDS-related complex. Ann Intern Med 1993; 118:321-30.
23. Bozzette SA, Richman DD. Salvage therapy for zidovudine-intolerant HIV-infected patients with alternating and intermittent regimens of zidovudine and dideoxycytidine. Am J Med 1990;88(suppl 5B):24S-6S.
24. Meng TC, Fischl MA, Boota AM, et al. A phase I/II study of combination therapy with zidovudine and dideoxycytidine in subjects with advanced human immunodeficiency virus (HIV) disease. Ann Intern Med 1992; 116:13-20.
25. 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;2:526-9.
26. Connolly KJ, Allan JD, Fitch H, et al. Phase 1 study of 2', 3'-dideoxyinosine (ddl) administered orally twice daily to patients with AIDS or AIDS-related complex and hematologic intolerance to zidovudine. Am J Med 1991;91:471-8.
27. Dornsife RE, St Clair MH, Huang AT, et al. Anti-human immunodeficiency virus synergism by zidovudine (3'-azidothymidine) and didanosine (dideoxyinosine) contrasts with their additive inhibition of normal human marrow progenitor cells. Antimicrob Agents Chemother 1991;35:322-8.
28. Johnson VA, Merrill DP, Videler JA, et al. Two-drug combinations of zidovudine, didanosine, and recombinant interferon-aA inhibit replication of zidovudine-resistant human immunodeficiency virus type I synergistically in vitro. J Infect Dis 1991;164:646-55.
29. Larder BA, Darby G, Richman DD. HIV with reduced sensitivity to zidovudine (AZT) isolated during prolonged therapy. Science 1989:243:1731-4.
30. Centers for Disease Control. Revision of the CDC surveillance case definition for acquired immunodeficiency syndrome. MMWR 1987:36(suppl): IS-15S.
31. Hartman NR. Yarchoan R. Pluda JM, et al. Pharmacokinetics of 2’, 3'-dideoxyinosine in patients with severe human immunodeficiency infection. II. The effects of different oral formulations and the presence of other medications. Clin Pharmacol Ther 1991;50:278-85.
32. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958:53:457-81.
33. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966:50:16370.
34. Kellam P, Boucher CAB, Larder BA. Fifth mutation in human immuno deficiency virus type 1 reverse transcriptase contributes to the development of high-level resistance to zidovudine. Proc Natl Acad Sci USA 1992;89:1934-8.
35. Cox SW, Albert J, Wahlberg J, Uklen M, Wahren B. Loss of synergistic response to combinations containing AZT in AZT-resistant HIV-1. AIDS Res Hum Retroviruses 1992:8:1229-34.
36. Perno CF, Yarchoan R, Cooney DA, etal. Replication ofhuman immunodeficiency virus in monocytes. Granulocyte/macrophage colony-stimulating factor (GM-CSF) potentiates viral production yet enhances the antiviral effect mediated by (3'-a/.idc)-2', 3'-dide()xythymidine (AZT) and other dideoxy nucleoside congeners of thymidine. J Exp Med 1989; 169:933 51.
37. Gao WY, Shirasaka T. Johns DG, Broder S, Mitsuya H. Differential phosphorylation ofazidothymidine. dideoxycytidine. and dideoxyin-osine in resting and activated peripheral blood mononuclear cells. J Clin Invest 1993;91:2326-33.
38. Wientjes MG, Au JLS. Lack of pharmacokinetic interaction between intravenous 2\3'-dideoxyinosine and 3'-azido-3'-deoxythymidine in rats. Antimicrob Agents Chemother 1992;36:665-8.
39. Fischl M, Parker C, Pettinelli C, et al. A randomized controlled trial ofa reduced daily dose of zidovudine in patients with acquired immunodeficiency syndrome. N Engl J Med 1990;323:1009-14.
40. Maxson CJ, Greenfield SM, Turner JL. Acute pancreatitis as a common complication of 2', 3'-dideoxyinosine therapy in the acquired immunodeficiency syndrome. Am J Gastroenterol 1992;87:708-13.
41. Chattha G, Arieff AI, Cummings C, Tierney LM Jr. Lactic acidosis complicating the acquired immunodeficiency syndrome. Ann Intern Med 1993; 118:37-9.
42. Freiman JP, Helfert KE, Hamrell MR, Stein DS. Hepatomegaly with severe steatosis in HIV-seropositive patients. AIDS 1993;7:379-85.
43. Lai KK, Gang DL, Zawacki JK. Cooley TP. Fulminant hepatic failure associated with 2', 3'-dideoxyinosine (ddl). Ann Intern Med 1991; 115:283-4.
44. Ahmed SR. Fialuridine trials stopped. Lancet 1993;342:166.
45. Collier AC, Fischl MA, Kaplan LD, et al. Effect of combination therapy with zidovudine (ZDV) and didanosine (ddl) on surrogate markers [abstract TU.B.2], In: Program and abstracts: VII International Conference on AIDS (Florence, Italy). Rome: Istituto Superiore di Sanitä, 1991.
46. Ragni M, Dafni R, Amato DA, Korvick J, Merigan TC. Combination zidovudine and dideoxyinosine in asymptomatic HIV(+) patients [abstract MoB 0055], In: Program and abstracts: VIII International Conference on A1DS/III STD World Congress (Amsterdam). Amsterdam: CONGREX Holland, 1992.
47. Chow YK, Hirsch MS, Merrill DP, etal. Use of evolutionary limitations of HIV-1 multidrug resistance to optimize therapy. Nature 1993;361:650-3.