Lamivudine in combination with zidovudine, stavudine, or didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial

AIDS

Volumn 13, Issue 6, 1999, Pages 685-694

  Kuritzkes, Daniel R ^a,b   Marschner, Ian ^a,m   Johnson, Victoria A ^a,l   Bassett, Roland ^a,k   Eron, Joseph J ^a,j   Fischl, Margaret A ^a,i   Murphy, Robert L ^a,h   Fife, Kenneth ^a,g   Maenza, Janine ^a,f   Rosandich, Mary E ^a,e   Bell, Dawn ^a,d   Wood, Ken ^a,c   Sommadossi, Jean Pierre ^a,b   Pettinelli, Caria ^a  

^a National Institute of Allergy and Infectious Disease   (United States)

^b UNIVERSITY OF COLORADO   (United States)

^c CENTER FOR BIOSTATISTICS IN AIDS RESEARCH   (United States)

^d UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^e UNIVERSITY OF NORTH CAROLINA   (United States)

^f UNIVERSITY OF MIAMI   (United States)

^g NORTHWESTERN UNIVERSITY   (United States)

^h INDIANA UNIVERSITY   (United States)

ⁱ JOHNS HOPKINS UNIVERSITY   (United States)

^j SCHOOL OF MEDICINE   (United States)

^k AIDS Clinical Trials Group Operations Center   (United States)

^l FRONTIER SCIENCE AND TECHNOLOGY RESEARCH FOUNDATION   (United States)

^m NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

more..

Author keywords

Antiretroviral therapy; Combination therapy; HIV; Lamivudine; Stavudine; Zidovudine

Indexed keywords

ANTIVIRUS AGENT; CD4 ANTIGEN; DIDANOSINE; LAMIVUDINE; STAVUDINE; VIRUS RNA; ZIDOVUDINE;

ANTIVIRAL ACTIVITY; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; T LYMPHOCYTE;

ADULT; ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; DIDANOSINE; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; LAMIVUDINE; MALE; REVERSE TRANSCRIPTASE INHIBITORS; RNA, VIRAL; STAVUDINE; VIRAL LOAD; ZIDOVUDINE;

EID: 0033064226     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002030-199904160-00009     Document Type: Article

References (27)

1. Centers for Disease Control and Prevention: Report of the NIH panel to define principles of therapy of HIV infection and guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. MMWR 1998, 47:No.RR-5.
2. Carpenter CJ, Fischl MA, Hammer SM, et al.: Antiretroviral therapy for HIV Infection in 1998JAVM 1998, 280:78-86.
3. Eron JJ, Benoît SL, Jemsek J, et al.: Treatment with lamivudine, zidovudine, or both in HIV-positive patients with 200 to 500 CD4+ cells per cubic millimeter. N Engl ] Med 1995, 333:1662-1669.
4. Kuritzkes DR, Quinn JB, Benoît SL, et al.: Drug resistance and virologie response in NUCA 3001, a randomized trial of lamivudine (3TC) versus zidovudine (ZDV) versus ZDV plus 3TC in previously untreated patients. AIDS 1996, 10:975-981.
5. Katlama C, Ingrand D, Loveday C, et al.: Safety and efficacy of lamivudine-zidovudine combination therapy in anlirelroviralnaive patients. A randomized controlled comparison with zidovudine monotherapy. JAMA 1996, 276:118-125.
6. Bartlett JA, Benoît SL, Johnson VA, et al.: Lamivudine plus zidovudine compared with zalcitabine plus zidovudine in patients with H1V infection. A randomized, double-blind, placebo-controlled trial. Ann Intern Med 1996, 125:161-172.
7. Phillips AN, Eron J, Bartlett J, e( al.: Correspondence between the effect of zidovudine plus lamivudine on plasma HIV Ievel/CD4 lymphocyte count and the incidence of clinical disease in infected individuals. AIDS 1997, 11:169-175.
8. CAESAR Coordinating Committee. Randomized trial of addition of lamivudine plus loviride to zidovudine-containing regimens for patients with HIV-1 infection: the CAESAR trial. Lancet 1997, 349:1413-1421.
9. Cao Q, Cu Z, Hiscott J, Dionne C, Wainberg MA. Generation of drug-resistant variants of human immunodeficiency virus type 1 by in vitro passage in increasing concentrations of 2',3'-dideoxycytidine and 2',3'-dideoxy-3'-thiacytidine. Anlimicrob Agents Chemother 1993, 37:130-133.
10. Boucher CAB, Cammack N, Schipper P, et al.: High-level resistance to (-) enantiomeric 2'-deoxy-3'-thiacytidine in vitro is due to one amino acid substitution in the catalytic site of human immunodeficiency virus type 1 reverse transcriptase. Antimicrob Agents Chemother 1993, 37:2231-2234.
11. Tisdale M, Kemp SD, Parry NR, Larder BA. Rapid in vitro selection of human immunodeficiency virus type 1 resistant to 3'thiacytidine inhibitors due to a mutation in the YMDD region of reverse transcriptase. Proc Natl Acad Sei USA 1993, 90:5653-5656.
12. Schinazi RF, Lloyd RM, Nguyen MH, et al.: Characterization of human immunodeficiency viruses resistant to oxalhiolane-cytosine nucleosides. Antimicrob Agents Chemother 1993, 37:875-881.
13. 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). ] Infect Dis 1995, 171:1411-1419.
14. Johnson VA, Wagner SF, Overbay CB, et al.: Drug resistance and viral load in NUCA 3002:A comparative trial of lamivudine (3TC) (high or low dose)/zidovudine (ZDV) combination therapy vs ZDV/dideoxycytidine (ddC) combination therapy in ZDV-experienced (24 weeks) patients (CD4 cells 100-300/mm3). 4th International Workshop on HIV Drug Resistance. Sardinia, July 1995 (abstract 55].
15. Cass RJA, Shugarts D, Young R, Alien M, Rosandich M, Kuritzkes DR. Emergence of dual resistance to zidovudine (ZDV) and lamivudine (3TC) in clinical HIV-1 isolates from patients receiving ZDV/3TC combination therapy. Antiviral Therapy 1998,3:97-102.
16. Larder BA, Kemp SD, Harrigan PR. Potential mechanism for sustained antiretroviral efficacy of AZT-3TC combination therapy. Science 1995, 269:696-699.
17. Rouleau D, Conway B, Raboud J, et al.: Stavudine plus lamivudine in advanced human immunodeficiency virus disease: a short-term pilot study. ] Infect Dis 1997, 176:1156-1160.
18. Katlama C, Valantin M-A, Matheron S, et al.: Efficacy and tolerability of stavudine plus lamivudine in treatment-naive and treatment-experienced patients with HIV-1 infection. Ann Intern Med 1998, 129:525-531.
19. 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, 124:1019-1030.
20. Celman R, Cheng SC, Kidd P, Waxdal M, Kagan J. Assessment of the effects of instrumentation, monoclonal antibody, and fluorochrome on flow cytometric immunophenotypic: a report based on 2 years of the NIAID DAIDS flow cytometry quality assessment program. C//n Immunol Immunopathol 1993,66:150-162.
21. SAS Institute Inc.: SAS/STAT User's Guide, Version 6. 4th Edn. Carey: SAS Institute Inc.; 1989:997-1025.
22. Altman DC. Practical Statistics for Medical Research. London: Chapman & Hall; 1991.
23. Collett D. Modeling Survival Data in Medical Research. London: Chapman & Hall; 1994.
24. Hammer SM, Katzenstein DA, Hughes MD, et al.: A trial comparing nucleoside monolherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. N Engl I Med 1996, 335:1081 -1090.
25. Englund JA, Baker CJ, Raskino C, et al.: Zidovudine, didanosine, or both as the initial treatment for symptomatic HIVinfected children. N Engl ] Med 1997, 336:1704-1712.
26. Katzenstein DA, Hammer SM, Hughes MD, e( aJ.: The relation of virologie and immunologie markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. N Eng/ ; Med 1996, 335:1091-1098.
27. McKinney Jnr RE, Johnson CM, Stanley K, et al.: A randomized study of combined zidovudine-lamivudine versus didanosine monotherapy in children with symptomatic therapy-naive HIV-1 infection. The Pédiatrie AIDS Clinical Trials Group Protocol Study Team. ; Pediatrics 1998, 133:500-508.