Efficacy and safety of combination therapy with delavirdine and zidovudine: A European/Australian phase II trial

International Journal of Antimicrobial Agents

Volumn 11, Issue 1, 1999, Pages

  Been Tiktak, Anne M M ^a,b   Boucher, Charles A B ^b   Brun Vezinet, Françoise ^c   Joly, Véronique ^c   Mulder, Jan W ^d   Jost, J ^e   Cooper, David A ^f,q   Moroni, Mauro ^g   Gatell, José M ^h   Staszewski, Schlomo ⁱ   Colebunders, Robert ^j   Stewart, Graeme J ^k,q   Hawkins, David A ^l   Johnson, Margaret A ^m   Parkin, Jacqueline M ⁿ   Kennedy, Dermot H ^o   Hoy, Jennifer F ^p,q   Borleffs, Jan C C ^a  

^a Department of Internal Medicine   (Netherlands)

^b UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^c BICHAT HOSPITAL   (France)

^d SLOTERVAART HOSPITAL   (Netherlands)

^e UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^f ST VINCENT S HOSPITAL   (Australia)

^g UNIVERSITY OF BOLOGNA   (Italy)

^h HOSPITAL CLÍNIC   (Spain)

ⁱ UNIVERSITY HOSPITAL FRANKFURT   (Germany)

^j INSTITUTE OF TROPICAL MEDICINE   (Belgium)

^k WESTMEAD HOSPITAL   (Australia)

^l CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

^m ROYAL FREE HOSPITAL   (United Kingdom)

ⁿ ST BARTHOLOMEW S HOSPITAL   (United Kingdom)

^o RUCHILL HOSPITAL   (United Kingdom)

^p ALFRED HOSPITAL   (Australia)

^q UNIVERSITY OF NEW SOUTH WALES   (Australia)

more..

Author keywords

Delavirdine; HIV; Zidovudine

Indexed keywords

ANTIHISTAMINIC AGENT; CD4 ANTIGEN; DELAVIRDINE; PLACEBO; ZALCITABINE; ZIDOVUDINE;

ADULT; AGED; ANTIVIRAL ACTIVITY; ARTICLE; CELL COUNT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG SENSITIVITY; FEMALE; GASTROINTESTINAL DISEASE; HEPATITIS B; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IN VITRO STUDY; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; THROMBOCYTOPENIA; VIRUS LOAD;

ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; DELAVIRDINE; DRUG THERAPY, COMBINATION; HIV INFECTIONS; HUMANS; REVERSE TRANSCRIPTASE INHIBITORS; VIRAL LOAD; ZIDOVUDINE;

EID: 18244412616     PISSN: 09248579     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0924-8579(98)00082-X     Document Type: Article

References (40)

1. Romero D.L., Morge R.A., Genin M.J. et al. Bis(heteroaryl)piperazine (BHAP) reverse transcriptase inhibitors: structure-activity relationships of novel substituted indole analogues and the identification of 1-[(5-methanesulfonamido-1H-indol-2-yl)-carbonyl]-4-[3- [(1-methylethyl)amino]-pyridinyl]piperazine monomethanesulfonate (U-90152S), a second-generation clinical candidate. J. Med. Chem. 36:1993;1505-1508.
2. Dueweke T.J., Poppe S.M., Romero D.L. et al. U-90152, a potent inhibitor of human immunodeficiency virus type 1 replication. Antimicrob. Agents Chemother. 37:1993;1127-1131.
3. Goldman M.E., Nunberg J.H., O'Brien J.A. et al. Pyridinone derivatives: specific human immunodeficiency virus type 1 reverse transcriptase inhibitors with antiviral activity. Proc. Natl. Acad. Sci. USA. 88:1991;6863-6867.
4. Pauwels R., Andries K., Desmyter J. et al. Potent and selective inhibition of HIV-1 replication in vitro by a novel series of TIBO derivatives. Nature. 343:1990;470-474.
5. Pauwels R., Andries K., Debyser Z. et al. Potent and highly selective human immunodeficiency virus type 1 (HIV-1) inhibition by a series of alpha-anilinophenylacetamide derivatives targeted at HIV-1 reverse transcriptase. Proc. Natl. Acad. Sci. USA. 90:1993;1711-7115.
6. Merluzzi V.J., Hargrave K.D., Labadia M. et al. Inhibition of HIV-1 replication by a nonnucleoside reverse transcriptase inhibitor. Science. 250:1990;1411-1413.
7. Been-Tiktak A.M., Vrehen H.M., Schneider M.M. et al. Safety, tolerance, and pharmacokinetics of atevirdine mesylate (U-87201E) in asymptomatic human immunodeficiency virus-infected patients. Antimicrob. Agents Chemother. 39:1995;602-607.
8. Spence R.A., Kati W.M., Anderson K.S., Johnson K.A. Mechanism of inhibition of HIV-1 reverse transcriptase by nonnucleoside inhibitors. Science. 267:1995;988-993.
9. Althaus I.W., Chou J.J., Gonzales A.J. et al. Steady-state kinetic studies with the non-nucleoside HIV-1 reverse transcriptase inhibitor U-87201E. J. Biol. Chem. 268:1993;6119-6124.
10. Dueweke T.J., Kézdy F.J., Waszak G.A. Jr., Deibel M.R., Tarpley W.G. The binding of a novel bisheteroarylpiperazine mediates inhibition of human immunodeficiency virus type 1 reverse transcriptase. J. Biol. Chem. 267:1992;27-30.
11. Condra J.H., Emini E.A., Gotlib L. et al. Identification of the human immunodeficiency virus reverse transcriptase residues that contribute to the activity of diverse nonnucleoside inhibitors. Antimicrob. Agents Chemother. 36:1992;1441-1446.
12. Mitsuya H., Yarchoan R., Broder S. Molecular targets for AIDS therapy. Science. 249:1990;1533-1544.
13. Fischl M.A., Richman D.D., Grieco M.H. et al. The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. New Engl. J. Med. 317:1987;185-191.
14. Been-Tiktak A.M.M., Williams I., Vrehen H.M. et al. Safety, tolerance, and efficacy of atevirdine in asymptomatic human immunodeficiency virus-infected individuals. Antimicrob. Agents Chemother. 40:1996;2664-2668.
15. Davey R.T., Chaitt D.G., Reed G.F. et al. Randomized, controlled phase I/II trial of combination therapy with delavirdine (U-90152S) and conventional nucleosides in human immunodeficiency virus type 1- infected patients. Antimicrob. Agents Chemother. 40:1996;1657-1664.
16. Havlir D., Cheeseman S.H., McLaughlin M. et al. High-dose nevirapine: safety, pharmacokinetics, and antiviral effect in patients with human immunodeficiency virus infection. J. Infect. Dis. 171:1995;537-1545.
17. Carpenter C.C.J., Fischl M.A., Hammer S.M. et al. Antiretroviral therapy for HIV infecytion in 1997: updated recommendations of the International AIDS Society USA Panel. JAMA. 277:1997;1962-1969.
18. Staszewski S., Massari F.E., Kober A. et al. Combination therapy with zidovudine prevents selection of human immunodeficiency virus type 1 variants expressing high-level resistance to L-697,661, a nonnucleoside reverse transcriptase inhibitor. J. Infect. Dis. 171:1995;1159-1165.
19. Romero D.L., Busso M., Tan C.K. et al. Nonnucleoside reverse transcriptase inhibitors that potently and specifically block human immunodeficiency virus type 1 replication. Proc. Natl. Acad. Sci. USA. 88:1991;8806-8810.
20. Campbell T.B., Young R.K., Eron J.J., D'Aquila R.T., Tarpley W.G., Kuritzkes D.R. Inhibition of human immunodeficiency virus type 1 replication in vitro by the bisheteroarylpiperazine atevirdine (U-87201E) in combination with zidovudine or didanosine. J. Infect. Dis. 168:1993;318-326.
21. Richman D., Rosenthal A.S., Skoog M. et al. BI-RG-587 is active against zidovudine-resistant human immunodeficiency virus type 1 and synergistic with zidovudine. Antimicrob. Agents Chemother. 35:1991;305-308.
22. Chong K.T., Pagano P.J., Hinshaw R.R. Bisheteroarylpiperazine reverse transcriptase inhibitor in combination with 3′-azido-3′-deoxythymidine or 2′,3′-dideoxycytidine synergistically inhibits human immunodeficiency virus type 1 replication in vitro. Antimicrob. Agents Chemother. 38:1994;288-293.
23. Richman D.D., Havlir D., Corbeil J. et al. Nevirapine resistance mutations of human immunodeficiency virus type 1 selected during therapy. J. Virol. 68:1994;1660-6166.
24. Nunberg J.H., Schleif W.A., Boots E.J. et al. Viral resistance to human immunodeficiency virus type 1-specific pyridinone reverse transcriptase inhibitors. J. Virol. 65:1991;4887-4892.
25. Saag M.S., Emini E.A., Laskin O.L. et al. A short-term clinical evaluation of L-697,661, a non-nucleoside inhibitor of HIV-1 reverse transcriptase. L-697,661 working group. New Engl. J. Med. 329:1993;1065-1072.
26. Dueweke T.J., Pushkarskaya T., Poppe S.M. et al. A mutation in reverse transcriptase of bis(heteroaryl)piperazine-resistant human immunodeficiency virus type 1 that confers increased sensitivity to other nonnucleoside inhibitors. Proc. Natl. Acad. Sci. USA. 90:1993;4713-4717.
27. Fan N., Evans D.B., Rank K.B., Thomas R.C., Tarpley W.G., Sharma S.K. Mechanism of resistance to U-90152S and sensitization to L-697, 661 by a proline to leucine change at residue 236 of human immunodeficiency virus type 1 (HIV-1) reverse transcriptase. FEBS Lett. 359:1995;233-238.
28. Larder B.A. 3′-Azido-3′-deoxythymidine resistance suppressed by a mutation conferring human immunodeficiency virus type 1 resistance to nonnucleoside reverse transcriptase inhibitors. Antimicrob. Agents Chemother. 36:1992;2664-2669.
29. Demeter LM, Shafer RW, Para M, et al. Delavirdine (DLV) susceptibility of HIV-1 isolates obtained from patients (PTS) receiving DLV monotherapy (ACTG 260). The 4th International Workshop on HIV Drug-Resistance. Sardinia, Italy, 6-9 July, 1995:Abstract 23.
30. World Medical Association. Recommendations guiding physicians in biomedical research involving human subjects. The 18th World Medical Assembly, Helsinki 1964. Amended at subsequent meetings at Tokyo (1975), Venice (1983) and Hong Kong (1989). Geneva, World Medical Association, 1964.
31. World Medical Association. Recommendations guiding physicians in biomedical research involving human subjects. The 18th World Medical Assembly, Helsinki 1964. Amended at subsequent meetings at Tokyo (1975), Venice (1983) and Hong Kong (1989). Geneva, World Medical Association, 1964.
32. Van Gemen B, Kievits T, Nara P, et al. Qualitative and quantitative detection of HIV-1 RNA by nucleic acid sequence-based amplification. 1993;7 Suppl 2:S107-110.
33. Boom R., Sol C.J.A., Salimans M.M.M., Jansen C.L., Wertheim-van Dillen P.M.E., Van der Noordaa J. A rapid and simple method for purification of nucleic acids. J. Clin. Microbiol. 28:1990;495-503.
34. Japour A.J., Mayers D.L., Johnson V.A. et al. Standardized peripheral blood mononuclear cell culture assay for determination of drug susceptibilities of clinical human immunodeficiency virus type 1 isolates. Antimicrob. Agents Chemother. 37:1993;1095-1101.
35. Coopman S.A., Johnson R.A., Platt R., Stern R.S. Cutaneous disease and drug reactions in HIV infection. New Engl. J. Med. 328:1993;1670-1674.
36. Carr A., Penny R., Cooper D.A. Efficacy and safety of rechallenge with low-dose trimethoprim-suphamethoxazole in previously hypersensitive HIV-infected patients. AIDS. 7:1993;65-71.
37. Van der Ven A.J.A.M., Koopmans P.P., Vree T.B. Adverse reactions to co-trimoxazole in HIV-infections. Lancet. 338:1991;431-433.
38. Toma E., Fournier S. Adverse reactions to co-trimoxazole in HIV infection. Lancet. 338:1991;954.
39. Gibbons R.B., Lindhauer J.A. Successful treatment of Pneumocystis carinii pneumonia with trimethoprim-sulphamethoxazole in hypersensitive AIDS patients. JAMA. 253:1985;1259-1260.
40. Freimuth WW. Delavirdine (DLV) in combination with zidovudine (ZDV) causes sustained antiviral and immunologic effects in HIV-1 infected individuals. In: Programs and Abstracts of the 3rd Conference on Retroviruses and Opportunistic Infections, Washington, DC, 1996:Abstract LB8a.