Randomised placebo-controlled trial of ritonavir in advanced HIV-1 disease

Lancet

Volumn 351, Issue 9102, 1998, Pages 543-549

  Cameron, D William ^a,e   Heath Chiozzi, Margo ^b   Danner, Sven ^c   Cohen, Calvin ^d   Kravcik, Stephen ^a   Maurath, Clement ^b   Sun, Eugene ^b   Henry, David ^b   Rode, Richard ^b   Potthoff, Amy ^b   Leonard, John ^b  

^a UNIVERSITY OF OTTAWA   (Canada)

^b ABBOTT LABORATORIES   (United States)

^c ACADEMIC MEDICAL CENTER   (Netherlands)

^d Comm Res Initiative of New England ^*  (United States)

^e UNIVERSITY OF OTTAWA   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

RITONAVIR;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADULT; AGED; ARTICLE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; FOLLOW UP; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT;

EID: 6844240219     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(97)04161-5     Document Type: Article

References (26)

1. 1 Fischl MA, Richman DD, Grieco MH, et al. The efficacy of azidopthymidine (AZT) in the treatment of patients with AIDS and AIDS-related complex. N Engl J Med 1987; 317: 185-91.
2. 2 Cooper DA, Gatell JM, Kroon S, et al. Zidovudine in persons with asymptomatic HIV infection and CD4+ cell counts greater than 400 per cubic millimeter. N Engl J Med 1933; 329: 297-303.
3. 3 Kinloch-de Loes S, Hirschel BJ, Hoen B, et al. A controlled trial of zidovudine in primary human immunodeficiency virus infection. N Engl J Med 1995; 333: 408-13.
4. 3: a double-blind, randomised controlled trial. Ann Intern Med 1995; 123; 561-71.
5. 5 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. N Engl J Med 1996; 335; 1081-90.
6. 6 Delta Coordinating Committee. Delta: a randomised double-blind controlled trial comparing combinations of zidovudine plus didanosine or zalcitabine with zidovudine alone in HIV-infected individuals. Lancet 1996; 348; 283-91.
7. 7 Saravolatz LD, Winslow DL, Collins G, et al. Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter. N Engl J Med 1996; 335: 1099-106.
8. 8 Kempf DJ, Marsh KC, Denissen JF, et al. ABT-538 is a potent inhibitor of human immunodeficiency virus protease and has high oral bioavailability in humans. Proc Natl Acad Sci USA 1995; 92: 2484-88.
9. 9 Danner SA, Carr A, Leonard JM, et al. A short-term study of the safety, pharmacokinetics, and efficacy of ritonavir, an inhibitor of HIV-1 protease. N Engl J Med 1995; 333: 1528-33.
10. 10 Markowitz M, Saag M, Powderly WG, et al. A preliminary study of ritonavir, an inhibitor of HIV-1 protease, to treat HIV-1 infection. N Engl J Med 1995; 333: 1534-39.
11. 11 Kelleher AD, Carr A, Zaunders J, Cooper DA. Alterations in the immune response of human immunodeficiency virus (HIV)-infected subjects treated with an HIV-specific protease inhibitor, ritonavir. J Infect Dis 1996; 173; 321-29.
12. 12 O Brien WA, Hartigan PM, Martin D, et al. Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS. N Engl J Med 1996; 334; 426-31.
13. 13 Katzenstein DA, Hammer SM, Hughes MD, et al. The relation of virologic and immunologic markers to clinical outcomes after nuc nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. N Engl J Med 1996; 335: 1091-98.
14. 14 Carr A, Emery S, Kelleher A. CD8+ lymphocyte responses to antiretroviral therapy in HIV infection. J Acquir Immune Defic Syndr Hum Retrovir 1996; 13; 320-26.
15. 15 Centers for Disease Control and Prevention. 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. Morbid Mortal Weekly Rep 1992; 41; RR-17.
16. 16 O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35: 549-56.
17. 17 Sun E, Heath-Chiozzi M, Cameron DW, et al. Concurrent ritonavir and rifabutin increases risk of rifabutin-associated adverse events. In: Abstracts of the XI International Conference on AIDS, Vancouver, Canada, July 7-12, 1996: MoB 171 abstr.
18. 18 Walker CM, Dewey J, Moody DP, et al. CD8+ lymphocytes can control HIV infection in vitro by suppressing virus replication. Science 1986; 234; 1563-66.
19. 19 Cocchi F, DeVico AL, Garzino-Demo A, et al. Identification of RANTES, MIP-1 and MIP-1 as the major HIV-suppressive factors produced by CD8+ T cells. Science 1995; 270: 1811-15.
20. 20 Autran G, Carcelain TS, Blanc C, et al. Positive effects of combined antiretroviral therapy on CD4+ T cell homeostasis and function in advanced HIV disease. Science 1997; 277: 112-16.
21. 21 Mathez D, Bagmarelli P, DeTruchis P, et al. A triple combination of ritonavir+AZT+DDC, as a first line treatment of patients with AIDS. In: Abstracts of the XI International Conference on AIDS, Vancouver, Canada, July 7-12, 1996: MoB 175 abstr.
22. 22 Lalazami J, Harbruch R, Burgen HU, Beattie D, Donatacci L, Salgo MP, and the NV14256 Study Team. Improved survival and decreased progression of HIV in patients treated with saquinavir plus zalcitabine. XI International Conference on AIDS, Vancouver, Canada, July 7-12, 1996 presentation LB.B.6033, p29, program supplement.
23. 3 or less. N Engl J Med 1997; 337; 725-33.
24. 24 Cameron DW. Ritonavir plus saquinavir combination therapy. Presented at the Third International Congress on Drug Therapy in HIV Infection, Birmingham, UK, Nov 3-7, SS5.6 abstr.
25. 25 Markowitz M, Cao Y, Hurley A, et al. Triple Therapy with AZT, 3TC, and Ritonavir in 12 Subjects Newly Infected with HIV-1. In: Abstracts of XI International Conference on AIDS, Vancouver, Canada, July 7-12, 1996: TH.B.933 abstr.
26. 26 Notermans DW, DeWolf F, Fondraine NA, et al. The effects of an antiretroviral triple combination with ritonavir, AZT and 3TC. In: Abstracts of the Third International Congress on Drug Therapy in HIV Infection, Birmingham, UK, Nov 3-7, 1996: OP8.2 abstr.