A randomized double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: The INCAS trial

JAMA

Volumn 279, Issue 12, 1998, Pages 930-937

  Montaner, Julio S G ^a   Reiss, Peter ^b   Cooper, David ^c   Vella, Stefano ^e   Harris, Marianne ^a   Conway, Brian ^a   Wainberg, Mark A ^f   Smith, D ^d   Robinson, Patrick ^g   Hall, David ^g   Myers, Maureen ^g   Lange, Joep M A ^b  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c UNIVERSITY OF NEW SOUTH WALES   (Australia)

^d UNIVERSITY OF NEW SOUTH WALES   (Australia)

^e ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^f MCGILL UNIVERSITY   (Canada)

^g BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DIDANOSINE; NEVIRAPINE; ZIDOVUDINE;

ADULT; ANTIVIRAL ACTIVITY; ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG POTENTIATION; FEMALE; HELPER CELL; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; VIRUS INHIBITION; VIRUS LOAD;

EID: 0032565098     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.279.12.930     Document Type: Article

References (30)

1. Merluzzi VJ, Margrave KD, Labadia M, et al. Inhibition of HIV-1 replication by a nonnucleoside reverse transcriptase inhibitor. Science. 1990;250: 1411-1413.
2. Koup RA, Merluzzi VJ, Hargrave KD, et al. Inhibition of human immunodeficiency virus type 1 (HIV-1) by the dipyridodiazepinone BI-RG-587. J Infect Dis. 1991;163:966-970.
3. Cheeseman SH, Hattox SE, McLaughlin MM, et al. Pharmacokinetics of nevirapine: initial single-rising-dose study in humans. Antimicrob Agents Chemother. 1993;37:178-182.
4. Luzuriaga K, Bryson Y, McSherry G, et al. Pharmacokinetics, safety, and activity of nevirapine in human immunodeficiency virus type 1-infected children. J Infect Dis. 1996;174:713-721.
5. Havlir D, Cheeseman SH, McLaughlin M, et al. High-dose nevirapine: safety, pharmacokinetics, and antiviral effect in patients with human immunodeficiency virus infection. J Infect Dis. 1995;171: 537-545.
6. Gu Z, Yudong Zhou ZL, Arts EJ, Wainberg MA. Effects of non nucleoside inhibitors of human immunodeficiency virus type 1 in cell-free recombinant reverse transcriptase assays. J Biol Chem. 1995;270:31046-31051.
7. 3: AIDS Clinical Trials Group protocol 208. J Infect Dis. 1995;172:1378-1383.
8. deJong MD, Vella S, Carr A, et al. High dose nevirapine in previously untreated HIV-1 infected persons does not result in sustained suppression of viral replication. J Infect Dis. 1997;175:966-970.
9. Richman D, Havlir D, Corbeil J, et al. Nevirapine resistance mutations of human immunodeficiency virus type 1 selected during therapy. J Virol. 1994; 68:1660-1666.
10. deJong MD, Lowenthal M, Boucher CAC, et al. Alternating nevirapine and zidovudine treatment of human immunodeficiency virus type 1-infected persons does not prolong nevirapine activity. J Infect Dis. 1994;169:1346.
11. Carr A, Vella S, deJong MD, et al, for the Dutch-Italian-Australian Nevirapine Study Group. A controlled trial of nevirapine plus zidovudine versus zidovudine alone in p24 antigenemic HIV-infected patients. AIDS. 1996;10:635-641.
12. D'Aquila RT, Hughes MD, Johnson VA, et al, and the National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group 241 Investigators. Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. Ann Intern Med. 1996;124: 1019-1030.
13. 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 RNA in plasma: application to acute retroviral infection. J Clin Microbiol. 1994;32:292-300.
14. Mulder J, Resnick R, Saget B, et al. A rapid and simple method for extracting human immunodeficiency virus type 1 RNA from plasma: enhanced sensitivity. J Clin Microbiol. 1997;35:1278-1280.
15. Kellam P, Larder BA. Recombinant virus assay: arapid, phenotypic assay for assessment of drug susceptibility of human immunodeficiency virus type 1 isolates. Antimicrob Agents Chemother. 1994; 38:23-30.
16. Pauwels R, Balzarini J, Baba M, et al. Rapid and automated tetrazolium-based colorimetric assay for the detection of anti-HIV compounds. J Virol Methods. 1988;20:309-321.
17. Delta Coordinating Committee. Delta: a randomized double-blind controlled trial comparing combinations of zidovudine plus didanosine and zalcitabine with zidovudine alone in HIV-infected individuals. Lancet. 1996;348:283-291.
18. 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;335:1081-1090.
19. Babiker A, for the Delta Coordinating Committee and Virology Group. Can HIV-1 RNA viral load be used as a surrogate for clinical endpoints in HIV disease? Paper presented at: Sixth European Conference on Clinical Aspects and Treatment of HIV-Infection; October 11-15, 1997; Hamburg, Germany. Abstract 103.
20. Katzenstein DA, Hammer SM, Hughes MD, et al. The relation of virologie and immunologic markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. N Engl J Med. 1996;335:1091-1098.
21. Cooper D, Katlama C, Montaner JSG, Collis P, and the CAESAR Coordinating Committee. Randomized trial of addition of lamivudine plus loviride to zidovudine-containing regimens for patients with advanced HIV-1 infection: the CAESAR trial. Lancet. 1997;349:1413-1421.
22. Montaner JSG, DeMasi R, Hill AM. The effects of lamivudine treatment on HIV-1 disease progres-sion are highly correlated with plasma HIV-1 RNA and CD4 cell count. AIDS. In press.
23. Hammer SM, Squires KE, Hughes MD, et al. A controlled trial of 2 nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. N Engl J Med. 1997; 337:725-733.
24. 3. Paper presented at: International Workshop on HIV Drug Resistance, Treatment Strategies and Eradication; June 25-28, 1997; St Petersburg, Fla. Abstract 67.
25. Carpenter CCJ, Fischl MA, Hammer SM, et al, for the International AIDS Society-USA. Antiretroviral therapy for HIV infection in 1996: recommendations of an international panel. JAMA 1996; 276:146-154.
26. Carpenter CCJ, Fischl MA, Hammer SM, et al. Antiretroviral therapy for HIV infection in 1997: updated recommendations of the International AIDS Society-USA Panel. JAMA. 1997;277: 1962-1969.
27. Goebel F, for the AVANTI Study Group. AVANTI 2: a randomized, double blind, comparative trial to evaluate combination antiretroviral regimens for the treatment of HIV-1 infection: AZT/ 3TC/indinavir in antiretroviral naive patients. Paper presented at: Sixth European Conference on Clinical Aspects and Treatment of HIV-Infection; October 11-15, 1997; Hamburg, Germany. Abstract 211.
28. Clumenck N, for the AVANTI Study Group. AVANTI 3: a randomized, double blind, comparative trial to evaluate the efficacy, safety and tolerance of AZT/3TC vs AZT/3TC/nelfinavir in antiretroviral naive patients. Paper presented at: Fifth Conference on Retroviruses and Opportunistic Infections; February 1-5, 1998; Chicago, Ill. Abstract 8.
29. Montaner JSG, Hogg RS, O'Shaughnessy MV. Emerging international consensus for the use of antiretroviral therapy. Lancet. 1997;349:1042.
30. Montaner JSG, Raboud JM, Rae S, et al. Predictors of duration of plasma viral load suppression. Paper presented at: Sixth European Conference on Clinical Aspects and Treatment of HIV-Infection; October 11-15, 1997; Hamburg, Germany. Abstract 105.