Efficacy and tolerability of stavudine plus lamivudine in treatment- naive and treatment-experienced patients with HIV-1 infection

Annals of Internal Medicine

Volumn 129, Issue 7, 1998, Pages 525-531

  Katlama, Christine ^a   Valantin, Marc Antoine ^a   Matheron, Sophie ^a   Coutellier, Anne ^a   Calvez, Vincent ^a   Descamps, Diane ^a   Longuet, Christophe ^a   Bonmarchand, Manuela ^a   Tubiana, Roland ^a   De Sa, Marcio ^a   Lancar, Rémi ^a   Agut, Henri ^a   Brun Vezinet, Françoise ^a   Costagliola, Dominique ^a  

^a BICHAT HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

LAMIVUDINE; STAVUDINE;

ANTIVIRAL ACTIVITY; ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERANCE; EOSINOPHILIA; GASTROINTESTINAL TOXICITY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LIVER TOXICITY; MAJOR CLINICAL STUDY; NEUROTOXICITY; PARESTHESIA; PRIORITY JOURNAL; RASH;

EID: 15644369614     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-129-7-199810010-00003     Document Type: Article

References (26)

1. Hammer SM, Katzenstein DA, Hughes MD, Gundacker MS, Schooley RT, Haubrich RH, et al. A trial comparing nudeoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. AIDS Clinical Trials Group Study 175 Study Team. N Engl J Med. 1996;335:1081-90.
2. Delta: a randomised double-blind controlled trial comparing combinations of zidovudine plus didanosine or zalcitabine with zidovudine alone in HIV-infected individuals. Delta Coordinating Committee. Lancet. 1996;348:283-91.
3. Randomised trial of addition of lamivudine or lamivudine plus loviride to zidovudine-containing regimens for patients with HIV-1 infection: the CAESAR trial. Lancet. 1997;349:1413-21.
4. D'Aquila RT, Johnson VA, Welles SL, Japour AJ, Kuritzkes DR, DeGruttola V, et al. Zidovudine resistance and HIV-1 disease progression during antiretroviral therapy. AIDS Clinical Trials Group Protocol 116B/117 Team and the Virology Committee Resistance Working Group. Ann Intern Med. 1995; 122:401-8.
5. Griffith BP, Brett-Smith H, Kim G, Mellors JW, Chacko TM, Garner RB, et al. Effect of stavudine on human immunodeficiency virus type 1 virus load as measured by quantitative mononuclear cell culture, plasma RNA, and immune complex-dissociated antigenemia. J Infect Dis. 1996;173:1252-5.
6. Murray HW, Squires KE, Weiss W, Sledz S, Sacks HS, Hassett J, et al. Stavudine in patients with AIDS and AIDS-related complex: AIDS Clinical Trials Group 089. J Infect Dis. 1995;171 Suppl 2:S123-30.
7. Petersen EA, Ramírez-Ronda CH, Hardy WD, Schwartz R, Sacks HS, Follansbee S, et al. Dose-related activity of stavudine in patients infected with human immunodeficiency virus. J Infect Dis. 1995;171 Suppl 2:S131-9.
8. 3: results of a double-blind randomized placebo controlled study [Abstract]. Program and Abstracts of the 3rd Conference on Retroviruses and Opportunistic Infections, Washington, DC, 28 January-1 February 1996:196.
9. Spruance SL, Pavia AT, Mellors JW, Murphy R, Gathe J Jr, Stool E, et al. Clinical efficacy of monotherapy with stavudine compared with zidovudine in HIV-infected, zidovudine-experienced patients. A randomized, double-blind, controlled trial. Bristol-Myers Squibb Stavudine/019 Study Group. Ann Intern Med. 1997;126:355-63.
10. Pollard R, Peterson D, Hardy D, Pedneault L, McLaren C, Skovronski J, et al. Antiviral effect and safety of stavudine (d4T) and didanosine (ddl) combination therapy in HIV-infected subjects in an ongoing pilot randomized double-blinded trial [Abstract]. Program and Abstracts of the 3rd Conference on Retroviruses and Opportunistic Infections, Washington, DC, 28 January-1 February 1996.
11. Eron JJ, Benoit SL, Jemsek J, MacArthur RD, Santana J, Quinn JB, et al. Treatment with lamivudine, zidovudine, or both in HIV-positive patients with 200 to 500 CD4+ cells per cubic millimeter. North American HIV Working Party. N Engl J Med. 1995;333:1662-9.
12. Katlama C, Ingrand D, Loveday C, Clumeck N, Mallolas J, Staszewski S, et al. Safety and efficacy of lamivudine-zidovudine combination therapy in antiretroviral-naive patients. A randomized controlled comparison with zidovudine monotherapy. Lamivudine European HIV Working Group. JAMA. 1996;276:118-25.
13. Staszewski S, Loveday C, Picazo JJ, Dellamonica P, Skinhøj P, Johnson MA, et al. Safety and efficacy of lamivudine-zidovudine combination therapy in zidovudine-experienced patients. A randomized controlled comparison with zidovudine monotherapy. Lamivudine European HIV Working Group. JAMA. 1996;276:111-7.
14. Bartlett JA, Benoit SL, Johnson VA, Quinn JB, Sepulveda GE, Ehmann WC, et al. Lamivudine plus zidovudine compared with zalcitabine plus zidovudine in patients with HIV infection. A randomized, double-blind, placebo-controlled trial. North American HIV Working Party. Ann Intern Med. 1996;125:161-72.
15. Schuurman R, Nijhuis M, van Leeuwen R, Schipper P, de Jong D, Collis P, 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;171:1411-9.
16. Wainberg MA, Drosopoulos WC, Salomon H, Hsu M, Borkow G, Parniak MA, et al. Enhanced fidelity of 3TC-selected mutant HIV-1 reverse transcriptase. Science. 1996;271:1282-5.
17. van Leeuwen R, Katlama C, Kitchen V, Boucher CA, Tubiana R, McBride M, et al. Evaluation of safety and efficacy of 3TC (lamivudine) in patients with asymptomatic or mildly symptomatic human immunodeficiency virus infection: a phase I/II study. J Infect Dis. 1995;171:1166-71.
18. Pluda JM, Cooley TP, Montaner JS, Shay LE, Reinhalter NE, Warthan SN, et al. A phase I/II study of 2′-deoxy-3′-thiacytidine (lamivudine) in patients with advanced human immunodeficiency virus infection. J Infect Dis. 1995;171:1438-47.
19. Larder BA, Kemp SD, Harrigan PR. Potential mechanism for sustained antiretroviral efficacy of AZT-3TC combination therapy. Science. 1995;269: 696-9.
20. Merrill DP, Moonis M, Chou TC, Hirsch MS. Lamivudine or stavudine in two- and three-drug combinations against human immunodeficiency virus type 1 replication in vitro. J Infect Dis. 1996;173:355-64.
21. Lin PF, Samanta H, Rose RE, Patick AK, Trimble J, Bechtold CM, et al. Genotypic and phenotypic analysis of human immunodeficiency virus type 1 isolates from patients on prolonged stavudine therapy. J Infect Dis. 1994;170: 1157-64.
22. Gillings D, Koch G. The application of the principle of intention-to-treat to the analysis of clinical trial. Drug Information Journal. 1991;25:411-24.
23. Perelson AS, Essunger P, Cao Y, Vesanen M, Hurley A, Saksela K, et al. Decay characteristics of HIV-1-infected compartments during combination therapy. Nature. 1997;387:188-91.
24. Katzenstein DA, Hammer SM, Hughes MD, Gundacker H, Jackson JB, Fiscus S, et al. The relation of virologic and immunologic markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. AIDS Clinical Trials Group Study 175 Virology Study Team. N Engl J Med 1996;335:1091-8.
25. Sommadossi JP, Valantin MA, Zhou XJ, Xie MY, Moore J, Calvez V, et al. Intracellular phosphorylation of stavudine (d4T) and 3TC correlates with their antiviral activity in naive and zidovudine (ZDV) experienced HIV-infected patients [Abstract]. Program and Abstracts of the 5th Conference on Retroviruses and Opportunistic Infections, Chicago, 1-5 February 1998:362.
26. Saravolatz LD, Winslow DL, Collins G, Hodges JS, Pettinelli C, Stein DS, 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. Investigators for the Terry Beirn Community Programs for Clinical Research on AIDS. N Engl J Med. 1996;335:1099-106.