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Details for Patent: 6,861,059

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Details for Patent: 6,861,059

Title: Methods and compositions for treatment of HIV-1 infection using antiviral compounds in simultaneous or sequential combinations
Abstract:Novel antiviral combinations for the treatment or prevention of viral infections, in particular, HIV, are disclosed. This new antiviral therapy employs either DP-178 or DP-107, viral fusion inhibitors, in combination with at least one other antiviral therapeutic agent. The combinations of the invention are better than single therapies alone, and in certain cases are synergistic. The use of DP-178 or DP-107 is an ideal therapy to combine with another antiviral, given both the novel mechanism which this therapeutic blocks HIV transmission and the non-toxicity of the therapeutic.
Inventor(s): Johnson; M. Ross (Chapel Hill, NC), Lambert; Dennis Michael (Cary, NC)
Assignee: Trimeris, Inc. (Durham, NC)
Filing Date:Sep 20, 2002
Application Number:10/252,136
Claims:1. A method of treating HIV-1 infection in a subject, comprising administering to the subject a therapeutically effective amount of DP-178 having SEQ ID NO:1, or a pharmaceutically acceptable derivative thereof, and a therapeutically effective amount of at least one other therapeutic agent which is a viral entry inhibitor, reverse transcriptase inhibitors or an inhibitor of HIV-1 protease.

2. The method of claim 1, wherein the pharmaceutically acceptable DP-178 derivative is a peptide selected from the group consisting of: T-624 having SEQ ID NO:55, T-636 having SEQ ID NO:56, T-637 having SEQ ID NO:57, T-638 having SEQ ID NO:58, T-639 having SEQ ID NO:59, T-640 having SEQ ID NO:60, T-641 having SEQ ID NO:61, T-645 having SEQ ID NO:62, T-646 having SEQ ID NO:63, T-647 having SEQ ID NO:64, T-648 having SEQ ID NO:65, T-649 having SEQ ID NO:66, T-650 having SEQ ID NO:67, T-652 having SEQ ID NO:68, T-653 having SEQ ID NO:69, T-654 having SEQ ID NO:70 and T-656 having SEQ ID NO:71.

3. The method of claim 1, wherein a therapeutic agent of the at least one other therapeutic agent is a viral entry inhibitor.

4. The method of claim 3, wherein the viral entry inhibitor is DP-107 having SEQ ID NO:82.

5. The method of claim 3, further comprising administering at least one reverse transcriptase inhibitor.

6. The method of claim 5, wherein the reverse transcriptase inhibitor is AZT, ddI, ddC, ddA, d4T or 3TC.

7. The method of claim 6, wherein the reverse transcriptase inhibitor is AZT.

8. The method of claim 6, wherein the reverse transcriptase inhibitor is ddI.

9. The method of claim 6, wherein the reverse transcriptase inhibitor is ddC.

10. The method of claim 6, wherein the reverse transcriptase inhibitor is ddA.

11. The method of claim 6, wherein the reverse transcriptase inhibitor is d4T.

12. The method of claim 6, wherein the reverse transcriptase inhibitor is 3TC.

13. The method of claim 3 or 5, further comprising at least one inhibitor of HIV-1 protease.

14. The method of claim 13, wherein the inhibitor of HIV-1 protease is indinavir.

15. The method of claim 1, wherein the administration is sequential.

16. The method of claim 15, wherein the sequential administration is cycling therapy.

17. The method of claim 16, further wherein the sequential administration of each agent comprising the cycling therapy is repeated one or more times in fixed order.

18. The method of claim 16, further wherein the cycling therapy comprises administration of an antiviral agent in alternation with administration of one or more other agents.

19. The method of claim 1, wherein the administration is simultaneous.

20. The method of claim 1, wherein the administration of at least one therapeutic agent is oral.

21. The method of claim 1, wherein the administration is parenteral.

22. The method of claim 21, wherein the parenteral administration is subcutaneous.

23. A method of treating HIV-1 infection in a subject, comprising administering to the subject a therapeutically effective amount of DP-178 having SEQ ID NO:1 and a therapeutically effective amount of at least one other therapeutic agent which is a viral entry inhibitor, reverse transcriptase inhibitor 1 or an inhibitor of HIV-1 protease.

24. The method of claim 23, wherein a therapeutic agent of the at least one other therapeutic agent is a viral entry inhibitor.

25. The method of claim 24, wherein the viral entry inhibitor is DP-107 having SEQ ID NO:82.

26. The method of claim 24, further comprising administering at least one reverse transcriptase inhibitor.

27. The method of claim 26, wherein the reverse transcriptase inhibitor is AZT, ddI, ddC, ddA, d4T or 3TC.

28. The method of claim 27, wherein the reverse transcriptase inhibitor is AZT.

29. The method of claim 27, wherein the reverse transcriptase inhibitor is ddI.

30. The method of claim 27, wherein the reverse transcriptase inhibitor is ddC.

31. The method of claim 27, wherein the reverse transcriptase inhibitor is ddA.

32. The method of claim 27, wherein the reverse transcriptase inhibitor is d4T.

33. The method of claim 27, wherein the reverse transcriptase inhibitor is 3TC.

34. The method of claim 24 or 26, further comprising administering at least one inhibitor of HIV-1 protease.

35. The method of claim 34, wherein the inhibitor of HIV-1 protease is indinavir.

36. The method of claim 23, wherein the administration is sequential.

37. The method of claim 36, wherein the sequential administration is cycling therapy.

38. The method of claim 36, further wherein the sequential administration of each agent comprising the cycling therapy is repeated one or more times in fixed order.

39. The method of claim 36, further wherein the cycling therapy comprises administration of an antiviral agent in alternation with administration of one or more other agents.

40. The method of claim 23, wherein the administration is simultaneous.

41. The method of claim 23, wherein the administration of at least one therapeutic agent is oral.

42. The method of claim 23, wherein the administration is parenteral.

43. The method of claim 42, wherein the parenteral administration is subcutaneous.

44. A method of inhibiting HIV-1 replication in a subject, comprising administering to the subject a therapeutically effective amount of DP-178 having SEQ ID NO:1, or a pharmaceutically acceptable derivative thereof, and a therapeutically effective amount of at least one other therapeutic agent which is a viral entry inhibitor, a reverse transcriptase inhibitor, or an inhibitor of HIV-1 protease.

45. The method of claim 44, wherein the pharmaceutically acceptable DP-178 derivative is a peptide selected from the group consisting of: T-624 having SEQ ID NO:55, T-636 having SEQ ID NO:56, T-637 having SEQ ID NO:57, T-638 having SEQ ID NO:58, T-639 having SEQ ID NO:59, T-640 having SEQ ID NO:60, T-641 having SEQ ID NO:61, T-645 having SEQ ID NO:62, T-646 having SEQ ID NO:63, T-647 having SEQ ID NO:64, T-648 having SEQ ID NO:65, T-649 having SEQ ID NO:66, T-650 having SEQ ID NO:67, T-652 having SEQ ID NO:68, T-653 having SEQ ID NO:69, T-654 having SEQ ID NO:70 and T-656 having SEQ ID NO:71.

46. The method of claim 44, wherein a therapeutic agent of the at least one other therapeutic agent is a viral entry inhibitor.

47. The method of claim 46, wherein the viral entry inhibitor is DP-107 having SEQ ID NO:82.

48. The method of claim 46, further comprising administering at least one reverse transcriptase inhibitor.

49. The method of claim 48, wherein the reverse transcriptase inhibitor is AZT, ddI, ddC, ddA, d4T or 3TC.

50. The method of claim 49, wherein the reverse transcriptase inhibitor is AZT.

51. The method of claim 49, wherein the reverse transcriptase inhibitor is ddI.

52. The method of claim 49, wherein the reverse transcriptase inhibitor is ddC.

53. The method of claim 49, wherein the reverse transcriptase inhibitor is ddA.

54. The method of claim 49, wherein the reverse transcriptase inhibitor is d4T.

55. The method of claim 49, wherein the reverse transcriptase inhibitor is 3TC.

56. The method of claim 46 or 48, further comprising administering at least one inhibitor of HIV-1 protease.

57. The method of claim 56, wherein the inhibitor of HIV-1 protease is indinavir.

58. The method of claim 56, wherein the administration is sequential.

59. The method of claim 58, wherein the sequential administration is cycling therapy.

60. The method of claim 59, further wherein the sequential administration of each agent comprising the cycling therapy is repeated one or more times in fixed order.

61. The method of claim 59, further wherein the cycling therapy comprises administration of an antiviral agent alternating with administration of one or more other agents.

62. The method of claim 44, wherein the administration is simultaneous.

63. The method of claim 44, wherein the administration of at least one therapeutic agent is oral.

64. The method of claim 44, wherein the administration is parenteral.

65. The method of claim 64, wherein the parenteral administration is subcutaneous.

66. A method of inhibiting HIV-1 replication in a subject, comprising administering to the subject a therapeutically effective amount of DP-178 having SEQ ID NO:1 and a therapeutically effective amount of at least one other therapeutic agent which is a viral entry inhibitor, a reverse transcriptase inhibitor, or an inhibitor of HIV-1 protease.

67. The method of claim 66, wherein a therapeutic agent of the at least one other therapeutic agent is a viral entry inhibitor.

68. The method of claim 66, wherein the viral entry inhibitor is DP-107 having SEQ ID NO:82.

69. The method of claim 66, further comprising administering at least one reverse transcriptase inhibitor.

70. The method of claim 69, wherein the reverse transcriptase inhibitor is AZT, ddI, ddC, ddA, d4T or 3TC.

71. The method of claim 70, wherein the reverse transcriptase inhibitor is AZT.

72. The method of claim 70, wherein the reverse transcriptase inhibitor is ddI.

73. The method of claim 70, wherein the reverse transcriptase inhibitor is ddC.

74. The method of claim 70, wherein the reverse transcriptase inhibitor is ddA.

75. The method of claim 70, wherein the reverse transcriptase inhibitor is d4T.

76. The method of claim 70, wherein the reverse transcriptase inhibitor is 3TC.

77. The method of claim 67 or 69, further comprising administering at least one inhibitor of HIV-1 protease.

78. The method of claim 77, wherein the inhibitor of HIV-1 protease is indinavir.

79. The method of claim 66, wherein the administration is sequential.

80. The method of claim 79, wherein the sequential administration is cycling therapy.

81. The method of claim 80, further wherein the sequential administration of each agent comprising the cycling therapy is repeated one or more times in fixed order.

82. The method of claim 80, further wherein the cycling therapy comprises administration of an antiviral agent alternating with administration of one or more other agents.

83. The method of claim 66, wherein the administration is simultaneous.

84. The method of claim 66, wherein the administration of at least one therapeutic agent is oral.

85. The method of claim 66, wherein the administration is parenteral.

86. The method of claim 85, wherein the parenteral administration is subcutaneous.

87. A pharmaceutical composition useful for the treatment of HIV-1 infection, comprising a therapeutically effective amount of DP-178 having SEQ ID NO:1, or a pharmaceutically acceptable derivative thereof, and a therapeutically effective amount of at least one other therapeutic agent which is a viral entry inhibitor, a reverse transcriptase inhibitors, or an inhibitor of HIV-1 protease, and a pharmaceutically acceptable carrier.

88. The pharmaceutical composition of claim 87, wherein the pharmaceutically acceptable DP-178 derivative is a peptide selected from the group consisting of: T-624 having SEQ ID NO:55, T-636 having SEQ ID NO:56, T-637 having SEQ ID NO:57, T-638 having SEQ ID NO:58, T-639 having SEQ ID NO:59, T-640 having SEQ ID NO:60, T-641 having SEQ ID NO:61, T-645 having SEQ ID NO:62, T-646 having SEQ ID NO:63, T-647 having SEQ ID NO:64, T-648 having SEQ ID NO:65, T-649 having SEQ ID NO:66, T-650 having SEQ ID NO:67, T-652 having SEQ ID NO:68, T-653 having SEQ ID NO:69, T-654 having SEQ ID NO:70 and T-656 having SEQ ID NO:71.

89. The pharmaceutical composition of claim 87, wherein a therapeutic agent of the at least one other therapeutic agent is a viral entry inhibitor.

90. The pharmaceutical composition of claim 89 wherein the viral entry inhibitor is DP-107 having SEQ ID NO:82.

91. The pharmaceutical composition of claim 8789, further comprising at least one reverse transcriptase inhibitor.

92. The pharmaceutical composition of claim 91, wherein the reverse transcriptase inhibitor is AZT, ddI, ddC, ddA, d4T or 3TC.

93. The pharmaceutical composition of claim 92, wherein the reverse transcriptase inhibitor is AZT.

94. The pharmaceutical composition of claim 92, wherein the reverse transcriptase inhibitor is ddI.

95. The pharmaceutical composition of claim 92, wherein the reverse transcriptase inhibitor is ddC.

96. The pharmaceutical composition of claim 92, wherein the reverse transcriptase inhibitor is ddA.

97. The pharmaceutical composition of claim 92, wherein the reverse transcriptase inhibitor is d4T.

98. The pharmaceutical composition of claim 92, wherein the reverse transcriptase inhibitor is 3TC.

99. The pharmaceutical composition of claim 8689 or 91, further comprising at least one inhibitor of HIV-1 protease.

100. The pharmaceutical composition of claim 99, wherein the inhibitor of HIV-1 protease is indinavir.

101. A pharmaceutical composition useful for the treatment of HIV-1 infection, comprising a therapeutically effective amount of DP-178 having SEQ ID NO:1 and a therapeutically effective amount of at least one other therapeutic agent which is a viral entry inhibitor, a reverse transcriptase inhibitors or an inhibitor of HIV-1 protease, and a pharmaceutically acceptable carrier.

102. The pharmaceutical composition of claim 101, wherein a therapeutic agent of the at least one other therapeutic agent is a viral entry inhibitor.

103. The pharmaceutical composition of claim 102, wherein the viral entry inhibitor is DP-107 having SEQ ID NO:82.

104. The pharmaceutical composition of claim 102, further comprising at least one reverse transcriptase inhibitor.

105. The pharmaceutical composition of claim 104, wherein the reverse transcriptase inhibitor is AZT, ddI, ddC, ddA, d4T or 3TC.

106. The pharmaceutical composition of claim 105, wherein the reverse transcriptase inhibitor is AZT.

107. The pharmaceutical composition of claim 105, wherein the reverse transcriptase inhibitor is ddI.

108. The pharmaceutical composition of claim 105, wherein the reverse transcriptase inhibitor is ddC.

109. The pharmaceutical composition of claim 105, wherein the reverse transcriptase inhibitor is ddA.

110. The pharmaceutical composition of claim 105, wherein the reverse transcriptase inhibitor is d4T.

111. The pharmaceutical composition of claim 105, wherein the reverse transcriptase inhibitor is 3TC.

112. The pharmaceutical composition of claim 102 or 104 further comprising at least one inhibitor of HIV-1 protease.

113. The pharmaceutical composition of claim 112, wherein the inhibitor of HIV-1 protease is indinavir.
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