Safety, pharmacokinetics, and antiretroviral activity of the potent, specific human immunodeficiency virus protease inhibitor nelfinavir: Results of a phase I/II trial and extended follow-up in patients infected with human immunodeficiency virus

Journal of Clinical Pharmacology

Volumn 38, Issue 8, 1998, Pages 736-743

  Moyle, Graeme J ^a   Youle, Michael ^a   Higgs, Chris ^a   Monaghan, Jo ^a   Prince, William ^a   Chapman, Sharon ^a   Clendeninn, Neil ^a   Nelson, Mark R ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CD4 ANTIGEN; DIDANOSINE; NELFINAVIR; PROTEINASE INHIBITOR; ZALCITABINE; ZIDOVUDINE;

ADULT; ANTIVIRAL ACTIVITY; ARTICLE; ASTHENIA; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; DOSE RESPONSE; DRUG FORMULATION; DRUG POTENCY; DRUG SAFETY; FLATULENCE; FOLLOW UP; HEADACHE; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HUMAN TISSUE; MALE; NAUSEA; ORAL DRUG ADMINISTRATION; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; VERTIGO; VIRUS INHIBITION;

EID: 0031865714     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1552-4604.1998.tb04814.x     Document Type: Article

References (19)

1. Kitchen VS, Skinner C, Ariyoshi K, et al: Safety and activity of saquinavir in HIV infection. Lancet 1995;345:952-955.
2. Danner SA, Carr A, Leonard JM, et al: A short-term study of the safety, pharmacokinetics, and efficacy of ritonavir, an inhibitor of HlV-1 protease. New Engl J Med 1995;333:1528-1533.
3. Markowitz M, Saag M, Powderly WG, et al: A preliminary study of ritonavir, an inhibitor of HIV-1 protease, to treat HIV-1 infection. New Engl J Med 1995;333:1534-1539.
4. Kelleher AD, Carr A, Zaunders J, Cooper DA: Alterations in the immune response of human immunodeficiency virus (HIV)-infected subjects treated with an HIV-specific protease inhibitor, ritonavir. J Infect Dis 1996;173:321-329.
5. Emini EA, Condra JH, Schleif WA, et al: Maintenance of long-term virus suppression in patients treated with the HIV-1 protease inhibitor Crixivan (indinavir) (abstract). Presented at the International Conference on AIDS, July 7-12, 1996. 1996;11:18.
6. Steigbigel R, Berry P, Teppler H, et al: Extended follow-up of patients in a study of indinavir at 800 mg q8h (2.4 g/d), 1000 mg q8h (3.0 g/d), and 800 mg q6h (3.2 g/d) (abstract). Presented at the International Conference on AIDS, July 7-12, 1996. 1996;11:25.
7. Baruch A, Mastrodonato-Delora P, Schnipper E, Salgo M: Efficacy and safety of triple combination therapy with invirase (saquinavir/SQV/HIV protease inhibitor), Epivir (3TC/lamivudine) and retrovir (ZDV/zidovudine) in HIV-infected patients (abstract). Presented at the International Conference on AIDS, July 7-12, 1996. 1996;11:18.
8. Cameron DW, Heath-Chiozzi M, Kravcik S, et al: Prolongation of life and prevention of AIDS complications in advanced HIV immunodeficiency with ritonavir: update (abstract). Presented at the International Conference on AIDS, July 7-12, 1996. 1996;11: 24.
9. Lalezari J, Haubrich R, Burger HU, et al: Improved survival and decreased progression of HIV in patients treated with saquinavir plus zalcitibine (abstract). Presented at the International Conference on AIDS, July 7-12, 1996. 1996;11 (program suppl):29.
10. Carpenter CCJ, Fischl MA, Hammer SM, et al: Antiretroviral therapy in HIV infection in 1996: recommendations of an international panel. JAMA 1996;276:146-154.
11. Gazzard BG, Moyle GJ, Weber J, et al: British HIV Association guidelines of antiretroviral treatment of HIV seropositive individuals. Lancet 1997;349:1086-1092.
12. Gazzard BG, Moyle GJ: Anti-infectives: to sequence or not to sequence? Exp Opin Invest Drugs 1997;6:99-102.
13. Shetty BV, Kosa MB, Khalil DA, Webber S: Preclinical pharmacokinetics and distribution to tissue of AG1343, an inhibitor of human immunodeficiency virus type 1 protease. Antimicrob Agents Chemother 1996;40:110-114.
14. Patick AK, Mo H, Markowitz M, et al: Antiviral and resistance studies of AG1343, an orally bioavailable inhibitor of human immunodeficiency virus protease. Antimicrob Agents Chemother 1996;40;292-297.
15. Quart BD, Chapman SK, Peterkin J, et al: Phase I safety, tolerance, pharmacokinetics, and food effect studies of AG1343: a novel HIV protease inhibitor (abstract). Presented at the Second National Conference on Human Retroviruses, January 29-February 2, 1995.
16. Henry K, Lamarca A, Myers A, Chapman S: The safety of Viracept (nelfinavir mesylate, NFV) in pivotal phase II/III double-blind randomized controlled trials as monotherapy and in combination with either d4T or AZT/3TC (abstract). Presented at the Fourth Conference on Retroviruses and Opportunistic Infections, January 22-26, 1997.
17. Powderly W, Sension M, Conant M, et al: The efficacy of Viracept (nelfinavir mesylate, NFV) in pivotal phase II/III double-blind randomized controlled trials as monotherapy and in combination with d4T or AZT/3TC (abstract). Presented at the Fourth Conference on Retroviruses and Opportunistic Infections, January 22-26, 1997.
18. Johnson M, Petersen A, Winslade J, Clendennin N: Comparison of BID and TID dosing of VIRACEPT (Nelfinavir, NFV) in combination with stavudine (d4T) and lamivudine (3TC) (abstract). Presented at the Fifth Conference on Retroviruses and Opportunistic Infections, February 1-5, 1998, Chicago, IL.
19. Perry CM, Benfield P: Nelfinavir. Drugs 1997;54:81-87.