Randomised trial of addition of lamivudine or lamivudine plus loviride to zidovudine-containing regimens for patients with HIV-1 infection: The CAESAR trial

Lancet

Volumn 349, Issue 9063, 1997, Pages 1413-1421

  Cooper, David ^a  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRETROVIRUS AGENT; DIDANOSINE; LAMIVUDINE; LOVIRIDE; ZALCITABINE; ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADULT; ANEMIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEATH; DIARRHEA; DISEASE COURSE; DOUBLE BLIND PROCEDURE; FEMALE; FEVER; HOSPITAL ADMISSION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUTROPENIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SURVIVAL TIME; THROMBOCYTOPENIA; VIRUS REPLICATION;

EID: 0030997937     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(97)04441-3     Document Type: Article

References (29)

1. Delta Co-ordinating 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.
2. 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 millimetre. N Engl J Med 1996; 335: 1081-90.
3. Cameron DW, Heath-Chiozzi M, Kravick S, et al. Prolongation of life and prevention of AIDS complications in advanced HIV immunodeficiency with ritonavir: an update. Abstract MoB411, XI International Conference on AIDS, July 7-12, 1996, Vancouver, Canada.
4. Salgo, MP, Beattie D, Bragman K, Donatacci L, Jones M, Montgomery L. Saquinavir (invirase, SQV) vs hivid (zalcitabine, ddC) vs combination as treatment for advanced HIV infection in patients discontinuing/ unable to take retrovir (zidovudine, ZDV). Abstract MoB410, XI International Conference on AIDS, July 7-12, 1996, Vancouver, Canada.
5. Eron JJ, Benoit SL, Jemsek J, et al. Treatment with lamivudine, zidovudine or both in HIV-positive patients with 200 to 500 CD4+ cells per millimetre. N Engl J Med 1995; 333: 1662-69.
6. Katlama C, Ingrand D, Loveday C, et al. Safety and efficacy of lamivudine-zidovudine combination therapy in antiretroviral naive patients. JAMA 1996; 276:118-25.
7. Staszewski S, Loveday C, Picazo JJ, Dellamonica P, Skinhoj P, Johnson M et al. Safety and efficacy of lamivudine-zidovudine combination therapy in zidovudine-experienced patients. JAMA 1996; 276: 111-17.
8. Bartlett JA, Benoit SL, Johnson VA, et al. Lamivudine plus zidovudine compared with zalcitabine plus zidovudine in patients with HIV infection. Ann Intern Med 1996; 125:161-72.
9. Staszewski S, Hill AM, Bartlett J, et al. Reductions in HIV-1 disease progression for ZDV/3TC relative to control treatments: a meta-analysis of controlled trials. AIDS 1997; 11: 477-83.
10. Centers for Disease Control and Prevention. 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR 1992; 41 (No. RR-17).
11. Lundgren JD, Pederson C, Clumeck N, et al. Survival differences in European patients with AIDS. BMJ 1994; 308: 1068-73.
12. Neaton JD, Wentworth DN, Rhame F, Hogan C, Abrams D and Deyton L. Considerations in choice of a clinical endpoint for AIDS clinical trials. Stat Med 1994; 13: 2107-25
13. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomised clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 1976; 34: 585-612.
14. Van Elteren PH. On the combination of independent two-sample tests of Wilcoxon. Bull Int Stat Inst 1960; 37: 351-61.
15. 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 millimetre. N Engl J Med 1996; 335: 1099-106.
16. Phillips AN, Lundgren JD for the EUROSIDA study group. Association of use of additional nucleoside analogues with mortality in 2410 patients initially treated with zidovudine. Abstract 563. Fourth Conference on Retroviruses and Opportunistic Infections, January 22-26, 1997, Washington DC, USA.
17. Schuurman R, Nijhuis M, van Leeuwen R, et al. Rapid changes in human immunodeficiency virus type 1 RNA load and appearance of drug-resistant virus populations in persons treated with lamivudine (3TC). J Infect Dis 1995; 171: 1411-19.
18. Back NKT, Nijhuis M, Keulen W, et al. Reduced replication of 3TC-resistant HIV-1 variants in primary cells due to a processivity defect of the reverse transcriptase enzyme. EMBO J 1996; 15: 4040-49.
19. Wainberg MA, Drosopoulos WC, Salomon H, et al. Enhanced fidelity of 3TC-selected mutant HIV-1 reverse transcriptase. Science 1996; 271: 1282-84.
20. Larder BA, Kemp SD, Harrigan PR. Potential mechanism for sustained antiretroviral efficacy of AZT-3TC combination therapy. Science 1995; 269: 696-99.
21. Kuritzkes DR, Quinn JB, Benoit SL, et al. Drug resistance and virologie response in NUC A3001, a randomized trial of lamivudine (3TC) versus zidovudine (ZDV) versus ZDV plus 3TC in previously untreated patients. AIDS 1996; 10: 975-81
22. Schooley RT, Ramirez-Ronda C, Lange JM, et al. Virologie and immunologic benefits of initial combination therpay with zidovudine and zalcitabine or didanosine compared with zidovudine monotherapy. J Infect D is 1996; 173: 1354-66.
23. Nijhuis M, Schuurman R, de Jong D, et al. Lamivudine resistant HIV-1 variants (M 184V) require multiple amino acid changes to become co-resistant to zidovudine in vivo. J Infect Dis (in press).
24. Rozenbaum W on behalf of AVANTI study group. AVANTI 1. A randomised double-blind comparative trial to evaluate the efficacy, safety and tolerance of combination antiretroviral regimens for the treatment of HIV-1 infection: AZT/3TC vs AZT/3TC/loviride in antiretroviral naive patients. Abstract 368 Fourth Conference on Retroviruses and Opportunistic Infections, January 22-26, 1997, Washington DC, USA.
25. 3. Abstr MoB 294 XIth International Conference on AIDS. Vancouver, BC, July 7-12, 1996.
26. D'Aquila RT, Hughes MD, Johnson VA, et al. Nevirapine, zidovudine and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. Ann Intern Med 1996; 124: 1019-30.
27. Carpenter CCJ, Fischl MA, Hammer SM, et al. Antiretroviral therapy for HIV infection in 1996. JAMA 1996; 276: 146-54.
28. BHIVA Guidelines Co-ordinating Committee. British HIV association guidelines for antiretroviral treatment of HIV seropositive individuals. Lancet 1997; 349: 1086-92.
29. Gulick RM, Mellors J, Havlir D, et al. Potent and sustained antiretroviral activity of indinavir (IDV), zidovudine (ZDV) and lamivudine (3TC). Abstract Th.B.931, XIth International Conference on AIDS, July 7-12, 1996, Vancouver BC, Canada.