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Claims for Patent: 6,475,491

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Claims for Patent: 6,475,491

Title: Treatment of HIV and other viral infections using combinatorial therapy
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)
Application Number:08/973,952
Patent 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 reverse transcriptase inhibitor or an inhibitor of HIV-1 protease.

2. The method of claim 1, wherein the therapeutic agent is a reverse transcriptase inhibitor.

3. The method of claim 2, wherein the reverse transcriptase inhibitor is AZT, ddI, ddC, ddA, d4T or 3TC.

4. The method of claim 1, wherein said 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.

5. The method of claim 1, wherein said administration is sequential.

6. The method of claim 1, wherein said administration is simultaneous.

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

8. The method of claim 1, wherein said administration is parenteral.

9. The method of claim 8, wherein said parenteral administration is intravenous.

10. The method of claim 1, wherein the therapeutic agent is an inhibitor of HIV-1 protease.

11. The method of claim 10, wherein the inhibitor of HIV-1 protease is indinavir.

12. The method of claim 2, wherein the reverse transcriptase inhibitor is AZT.

13. The method of claim 2, wherein the reverse transcriptase inhibitor is 3TC.

14. 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 reverse transcriptase inhibitor or an inhibitor of HIV-1 protease.

15. The method of claim 14, wherein the therapeutic agent is a reverse transcriptase inhibitor.

16. The method of claim 15, wherein the reverse transcriptase inhibitor is AZT, ddI, ddC, ddA, d4T or 3TC.

17. The method of claim 14, wherein said administration is sequential.

18. The method of claim 14, wherein said administration is simultaneous.

19. The method of claim 14, wherein said administration of at least one therapeutic agent is oral.

20. The method of claim 14, wherein said administration is parenteral.

21. The method of claim 20, wherein said administration is intravenous.

22. The method of claim 14, wherein the therapeutic agent is an inhibitor of HIV- 1 protease.

23. The method of claim 22, wherein the inhibitor of HIV-1 protease is indinavir.

24. The method of claim 15, wherein the reverse transcriptase inhibitor is AZT.

25. The method of claim 15, wherein the reverse transcriptase inhibitor is 3TC.

26. 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, a therapeutically effective amount of at least one other therapeutic agent which is a reverse transcriptase inhibitor or an inhibitor of HIV-1 protease, and a pharmaceutically acceptable carrier.

27. The pharmaceutical composition of claim 26, wherein the therapeutic agent is a reverse transcriptase inhibitor.

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

29. The pharmaceutical composition of claim 26, wherein the therapeutic agent is an inhibitor of HIV-1 protease.

30. The pharmaceutical composition of claim 29, wherein the inhibitor of HIV-1 protease is indinavir.

31. The pharmaceutical composition of claim 27, wherein the reverse transcriptase inhibitor is AZT.

32. The pharmaceutical composition of claim 27, wherein the reverse transcriptase inhibitor is 3TC.
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