Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection a randomized, double-blind, placebo-controlled trial

Annals of Internal Medicine

Volumn 124, Issue 12, 1996, Pages 1019-1030

  D'Aquila, Richard T ^k   Hughes, Michael D ^l   Johnson, Victoria A ^m   Fischl, Margaret A ⁿ   Sommadossi, Jean Pierre ^m   Liou, Song Heng ^o   Timpone, Joseph ^p   Myers, Maureen ^q   Basgoz, Nesli ^k   Niu, Manette ^r   Hirsch, Martin S ^k   Saag, Michael ^a   Weingarten, Jill ^a   Gnann, John ^a   Havlir, Diane ^b   Fegan, Chris ^b   Spector, Stephen ^b   Richman, Douglas ^b   Jacobson, Mark ^b   Dybeck, Kathy ^b   Joseph, Patrick ^b   Clanon, Kathleen ^b   McKenzie, Stacey ^c   Daniel, Pam ^c   Dayton, Dale ^c   Leonard, Jill ^c   Schooley, Robert ^c   Kuritzkes, Daniel ^c   Ray, Graham ^c   Putnam, Beverly ^c   Jayaweera, Dushyantha ^d   Patrone Reese, Janie ^d   Tanner, Thomas ^d   Moebus, Jo ^d   Reed, Nancy ^e   Jacque, Renee St ^e   Henry, Keith ^e   Swindells, Susan ^e   Eron, Joe ^e   Ragan, David ^f   Horton, James ^f   Lane, Timothy ^f   Frank, Ian ^f   Norris, Anne ^g   Pomerantz, Roger ^g   Hauptman, Stephen ^g   Geiseler, Jan ^h   Leedom, John ^h   Canchola, Frances ^h   Olson, Connie ⁱ   Deyton, Lawrence ^j   Pettinelli, Carla ^j   more..

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF CINCINNATI   (United States)

^d UNIVERSITY OF COLORADO   (United States)

^e UNIVERSITY OF MIAMI   (United States)

^f UNIVERSITY OF MINNESOTA   (United States)

^g UNIVERSITY OF NORTH CAROLINA   (United States)

^h UNIVERSITY OF PENNSYLVANIA   (United States)

ⁱ UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

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

^k MASSACHUSETTS GENERAL HOSPITAL   (United States)

^l HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^m UNIVERSITY OF ALABAMA SCHOOL OF MEDICINE   (United States)

ⁿ UNIVERSITY OF MIAMI MILLER SCHOOL OF MEDICINE   (United States)

^o GENENTECH INC   (United States)

^p GEORGETOWN UNIVERSITY MEDICAL CENTER   (United States)

^q BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^r CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIGEN P24; ANTIRETROVIRUS AGENT; CD4 ANTIGEN; DIDANOSINE; NEVIRAPINE; PLACEBO; RNA DIRECTED DNA POLYMERASE INHIBITOR; ZIDOVUDINE;

ADULT; ANEMIA; ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE COURSE; DOUBLE BLIND PROCEDURE; FATIGUE; FEMALE; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYOSITIS; NAUSEA; NEUTROPENIA; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; TREATMENT OUTCOME; VIRUS INFECTIVITY; VIRUS INHIBITION; VIRUS TITRATION; VOMITING;

ADULT; CD4 LYMPHOCYTE COUNT; DIDANOSINE; DISEASE PROGRESSION; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; ERYTHEMA; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; NEVIRAPINE; PROSPECTIVE STUDIES; PYRIDINES; REVERSE TRANSCRIPTASE INHIBITORS; RNA, VIRAL; ZIDOVUDINE;

EID: 0030317268     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-124-12-199606150-00001     Document Type: Article

References (46)

1. Dornsife RE, St. Clair MH, Huang AT, Panella TJ. Koszalka GW, Bums CL, et al. Anti-human imunodeficiency virus synergism by zidovudine (3′-azidothymidine) and didanosine (dideoxyinosine) contrasts with their additive inhibition of normal human marrow progrenitor cells. Antimicrob Agents Chemother. 1991;35:322-8.
2. Johnson VA, Merrill DP, Videler JA, Chou TC, Byington RE, Eron II, et al. Two-drug combinations of zidovudine, didanosine, and recombinant interferon-alpha A inhibit replication of zidovudine-resistant human immunodeficiency virus type 1 synergistically in vitro. J Infect Dis. 1991;164:646-55.
3. Merluzzi VJ, Margrave KD, Labadia M, Grozinger K, Skoog M, Wu JC et al. Inhibition of HIV-1 replication by a nonnucleoside reverse transcriptase inhibitor. Science. 1990;250:1411-3.
4. Richman D, Rosenthal AS, Skoog M, Eckner RJ, Chou TC, Sabo JP, et al. BI-RG-587 is active against zidovudine-resistant human immunodeficiency virus type 1 and synergistic with zidovudine. Antimicrob Agents Chemother. 1991;35:305-8.
5. Koup RA, Brewster F, Grob P, Sullivan JL. Nevirapine synergistically inhibits HIV-1 replication in combination with zidovudine, interferon or CD4 immunoadhesin. AIDS. 1993;7:1181-4.
6. Collier AC, Coombs RW, Fischl MA, Skolnik PR, Northfelt D, Boutin P, et al. Combination therapy with zidovudine and didanosine compared with zidovudine alone in HIV-1 infection. Ann Intern Med. 1993;119:786-93.
7. Yardioan R, Lietzau JA, Nguyen BY, Brawley OW, Pluda JM, Saville MW, et al. A randomized pilot study of alternating or simultaneous zidovudine and didanosine therapy in patients with symptomatic human immunodeficiency virus infection. J Infect Dis. 1994;169:9-17.
8. Kojima E, Shirasaka T, Anderson BD, Chokekijchai S, Steinberg SM, Broder S, et al. Human immunodeficiency virus type 1 (HIV-1) viremia changes and development of drug-related mutations in patients with symptomatic HIV-1 infection receiving alternating or simultaneous zidovudine and didanosine therapy. J Infect Dis. 1996;171:1152-8
9. 3 [Abstract]. In: Program and Abstracts-35th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, 17-20 September 1995. Washington, DC: Amer Soc for Microbiology: 1995:LB-1.
10. Yeni P, International Coordinating Committee. Preliminary results of the European/Australian Delta trial based on data up to 31 May 1995 [Abstract] 5th European Conference on Clinical Aspects and Treatment of HIV Infection Copenhagen, Denmark, 26-29 September 1995.
11. Schooley RT, Cooper D, Moore MD, McKinnis R, Rooney JF, Wellcome Resistance Study Group. Initial combination therapy with ZDV+ddl or ZDV+ddC vs. ZDV [Abstract], In: Program and Abstracts of the 3rd Conference on Retroviruses and Opportunistic Infections. Washington, DC, 28 January-1 February 1996:202.
12. Chow YK, Hirsch MS, Merrill DP, Bechtel LJ, Eron JJ, Kaplan JC, et al. Use of evolutionary limitations of HIV-1 multidrug resistance to optimize therapy. Nature. 1993;361:650-4.
13. Rusconi S, Merrill DP, Hirsch MS. Inhibition of human immunodeficiency virus type 1 replication in cytokine-stimulated monocytes/macrophages by combination therapy. J Infect Dis. 1994;170:1361-6.
14. Mazzulli T, Rusconi S, Merrill DP, D'Aquila RT, Moonis M, Chou TC, et al. Alternating versus continuous drug regimens in combination chemotherapy of human immunodeficiency virus type 1 infection in vitro. Antimicrob Agents Chemother. 1994;38:656-61.
15. Wilson CC, Wong JT, Girard DD. Merrill DP, Dynan M, An DO, et al. Ex vivo expansion of CD4 lymphocytes from human immunodeficiency virus type 1-infected persons in the presence of combination antiretroviral agents. J Infect Dis. 1995;172:88-96.
16. Cheeseman SH, Havlir D, McLaughlin MM, Greenough TC Sullivan JL, Hall D, et al. Phase I/ll evaluation of nevirapine alone and in combination with zidovudine for infection with human immunodeficiency virus. J Acquir Immune Defic Syndr. 1995;8:141-51.
17. Havlir D, Cheeseman SH. McLaughlin M, Murphy R, Erice A, Spector SA, et al. High-dose nevirapine: safety, pharmacokinetics, and antiviral effect in patients with human immunodeficiency virus infection. J Infect Dis. 1995;171:537-45.
18. Saag M, Johnson V, Wei X, Sommadossi JP, Myers M, Cort S, et al. Clinical, pharmacokinetic, and virologic results in adults treated with nevirapine in combination with AZT/ddC, AZT/ddl, or ddl alone. Final report of the BI 1009 Study. In: Proceedings and Abstracts - 34th Interscience Conference on Antimicrobial Agents and Chemotherapy Orlando, Florida, 1994. Washington, DC: Amer Soc for Microbiology; 1994.
19. Emini EA, Graham DJ, Gotlib L, Condra JH, Byrnes VW, Schleif WA. HIV and multidrug resistance [Letter] Nature. 1993;364:679.
20. Larder BA, Kellam P, Kemp SD. Convergent combination therapy can select viable multi-drug resistant HIV-1 in vitro. Nature. 1993;365:451-3.
21. Gelman R, Cheng SC, Kidd P, Waxdal M, Kagan J. Assessment of the effects of instrumentation, monoclonal antibody, and fluorochrome on flow cytometric immunophenotyping: a report based on 2 years of the NIAID DADS flow cytometry quality assessment program. Clin Immunol Immunopathol. 1993;66:150-62.
22. Calvelli T, Denny TN, Paxton H, Gelman R, Kagan J. Guideline for flow cytometric immunophenotyping: a report from the National Institute of Allergy and Infectious Diseases, Division of AIDS. Cytometry. 1993;14:70215.
23. Jayaraj A, Alexander J, Price C. A rapid and sensitive HPLC-UV method for the quantitation of an anti-HIV agent, nevirapine, and its solid phase extractable metabolites in biological fluids. Pharm Res. 1992;9:S334.
24. Myers LE, McQuay U, Hollinger FB. Dilution assay statistics. J Clin Microbiol. 1994;32:732-9.
25. Mulder J, McKinney N, Christopherson C Sninsky J, Greenfield L, Kwok S. Rapid and simple PCR assay for quantitation of human immunodeficiency virus type 1 UNA in plasma: application to acute retroviral infection. J Clin Microbiol. 1994;32:292-300.
26. Kang HJ, Wientjies MG, Au JL Tissue pharmacokinetics of 2′,3′-dideoxyinosine in rats. Biochem Pharmacol. 1994;48:2109-16.
27. Tadepalli SM, Puckett L, Jeal S, Kanics L, Quinn RP. Differential assay of zidovuidne and its glucuronide metabolite in serum and urine with a radioimmunoassay kit. Clin Chem. 1990;36:897-900.
28. Japour AJ, Fiscus SA, Arduino JM, Mayers DL, Reichelderfer PS, Kuritzkes DR. Standardized microtiter assay for determination of syncytiuminducing phenotypes of clinical human immunodeficiency virus type 1 isolates. J Clin Microbiol. 1994;32:2291-4.
29. 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR Morb Mortal Wkly Rep. 1992;41(RR-17):1-19.
30. Pocock SJ. Clinical Trials: A Practical Approach. New York: J Wiley: 1983.
31. Draper NR, Smith H. Applied Regression Analysis. New York: J Wiley; 1981.
32. Kalbfleisch JD, Prentice RL The Statistical Analysis of Failure Time Data. New York: J Wiley; 1980.
33. Cheeseman SH, Hattox SE, McLaughlin MM. Koup RA, Andrews C, Bova CA, et al. Pharmacokinetics of nevirapine: initial single-rising-dose study in humans. Antimicrob Agents Chemother. 1993;37:178-82.
34. 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.
35. Collier AC. Coombs RW, Schoenfeld DA, Bassett RL, Timpone J, Baruch A, et al. Treatment of human immunodeficiency virus infection with saquinivir, zidovudine, and zalcitabine. N Engl J Med. 1996;334:1011-7.
36. Gulick R, Mellon J, Havlir D, Eron J, Gonzalez C, McMahon D, et al. Potent and sustained antiretroviral activity of indinavir in combination with zidovudine and lamivudine [Abstract]. In: Program and Abstracts of the 3rd Conference on Human Retroviruses and Opportunistic Infections. Washington, DC, 28 January-1 February 1996:LB7.
37. Meng TC, Fischl MA, Boota AM, Spector SA, Bennett D, Bassiakos Y, et al. Combination therapy with zidovudine and dideoxycytidine in patients with advanced human immunodeficiency virus infection. A phase VII study. Ann Intern Med. 1992;116:13-20.
38. Eron J, 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.
39. Larder BA, Kemp SD, Harrigan PR. Potential mechanism for sustained antiretroviral efficacy of AZT-3TC combination therapy. Science. 1995;269: 696-9.
40. Fischl MA, Richman DD, Hansen N, Collier AC, Carey JT, Para MF, et al. The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection. A double-blind, placebo-controlled trial. The AIDS Clinical Trials Group. Ann Intern Med. 1990;112:727-37.
41. Mellors JW, Kingsley LA. Rinaldo CR Jr. Todd JA, Hoo BS, Kokka RP, et al. Quantitation of HIV-1 RNA in plasma predicts outcome after seroconversion. Ann Intern Med. 1995;122:573-9.
42. O'Brien WA, Hartigan PM, Martin D, Esinhart J, Hill A, Benoit S, et al. Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS. Veterans Affairs Cooperative Study Group on AIDS. N Eng J Med. 1996;334:426-31.
43. Report by the Bioequivalence Task Force on recommendations from the bioequivalence hearings conducted by the Food and Drug Administration, September 29-October 1, 1986. Rockville, MD: Food and Drug Administration: January 1988.
44. Collier AC, Bozzette S, Coombs RW, Causey DM, Schoenfeld DA, Spector SA, et al. A pilot study of low-dose zidovudine in human immunodeficiency virus infection. N Engl J Med. 1990;323:1015-21.
45. Coffin JM. HIV population dynamics in vivo: implications for genetic variation, pathogenesis, and therapy. Science. 1995;267:483-9.
46. Cameron B, Heath-Chiozzi M, Kravick S, Mills R, Potthoff A, Henry D, et al. Prolongation of life and prevention of AIDS in advanced HIV immuno-deficiency with ritonavir [Abstract]. In: Program and Abstracts of the 3rd Conference on Human Retroviruses and Opportunistic Infections Washington, DC, 28 January-1 February 1996:LB6a.