Relationships between exposure to saquinavir monotherapy and antiviral response in HIV-positive patients

Clinical Pharmacokinetics

Volumn 37, Issue 1, 1999, Pages 75-86

  Gieschke, Ronald ^a   Fotteler, Bärbel ^a   Buss, Neil ^a   Steimer, Jean Louis ^a  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

CD4 ANTIGEN; SAQUINAVIR; VIRUS RNA;

ABDOMINAL PAIN; ADULT; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG FORMULATION; DYSPEPSIA; FEMALE; HEADACHE; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LEUKOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MATHEMATICAL MODEL; MULTICENTER STUDY; NAUSEA; ORAL DRUG ADMINISTRATION; PHARMACODYNAMICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; VIRUS LOAD;

ADULT; AREA UNDER CURVE; CAPSULES; CD4 LYMPHOCYTE COUNT; DRUG ADMINISTRATION SCHEDULE; FEMALE; HIV; HIV PROTEASE INHIBITORS; HIV SEROPOSITIVITY; HUMANS; MALE; MODELS, THEORETICAL; RNA, VIRAL; SAQUINAVIR;

EID: 0032765435     PISSN: 03125963     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003088-199937010-00005     Document Type: Article

References (17)

1. 1. Collier AC, Coombs RW, Schoenfeld DA, et al. Treatment of human immunodeficiency virus infection with saquinavir, zidovudine and zalcitabine N Engl J Med 1996; 334: 1011-7
2. 2. Haubrich R, Burger HU, Beattic D, et al. Saquinavir + zalcitabine vs saquinavir or zalcitabine monotherapy in HIV-infected patients discontinuing as intolerant to zidovadine-results of a randomised, double blind trial. AIDS 1996; 10 Suppl. 2: OP4.2
3. 3. Stellbrink H-J, Invirasc International Phase III Trial (SV-14604) Group. Clinical and survival benefit of saquinavir (SQV) in combination with zalcitabine (ddC) and zidovudine (ZDV) in untreated/minimally treated HIV-infected patients [abstract 2121]. 6th European Conference on Clinical Aspects and Treatment of HIV-Infection; 1997 Oct 11 15; Hamburg
4. 4. Vella S, Lazzarin A, Carosi G, et al. A randomised controlled trial of a protease inhibitor (saquinavir) in combination with zidovudine in previously untreated patients with advanced HIV infection. Antiviral Ther 1996 Aug; 1: 129-40
5. 5. Muirhead GJ, Shaw T, Williams PEO, et al. Pharmacokinetics of the HIV-proteinase inhibitor, Ro 318959, after single and multiple oral doses in healthy volunteers [abstract]. Br J Clin Pharmacol 1992 Aug; 34: 170P-IP
6. 6. Noble S, Faulds D. Saquinavir: a review of its pharmacology and clinical potential in the management of HIV infection. Drugs 1996; 52: 93-112
7. 7. Schapiro JM, Winters MA, Stewart E, et al. The effect of highdose saquinavir on viral load and CD4 T-cell counts in HIV-infected patients. Ann Intern Med 1996; 124: 1039-50
8. 8. Mellors JW, Rinaldo Jr CR, Gupta P, et al. Prognosis in HIV-I infection predicted by the quantity of virus in plasma. Science 1996; 272: 1167-70
9. 9. de Wolf F, Spijkerman I, Schellekens PTh, et al. AIDS prognosis based on HIV-1 RNA, CD4+ T-cell count and function: markers with reciprocal predictive value over time after scroconversion. AIDS 1997; 11: 1799-806
10. 10. Schwarz G. Estimating the dimensions of a model. Ann Statistics 1978; 6: 461-4
11. 11. Akaike H. A new look at the statistical model identification. IEEE Trans Automatic Control 1974; 19: 716-23
12. 12. Lalezari J, NV 15107 Study Group. Selecting the optimum dose for a new soft gelatin capsule formulation of saquinavir. J AIDS Hum Retrovirol 1998; 19: 195-7
13. 13. Sale ME, Blaschke TF. Incorporating pharmacokinetic/pharmacodynamic modelling in drug development: are we ready? Drug Inf J 1992; 26: 119-24
14. 14. Sambol NC, Clementi WA, Sheiner LB. Population dose-response relationships determined from efficacy trials: the antihyperten sive effect of atenolol and betaxolol. J Pharmacokinet Biopharm 1991; 19 Suppl. 3: 79S-91S
15. 15 Mitsuyasu RT, Skolnik PR, Cohen SR, et al. Activity of the soll gelatin formulation of saquinavir in combination therapy in antiretroviral-naive patients. AIDS 1998; 12: F103-9
16. 16. Vanhove GF, Grits, J-M, Verotta D, et al. Exposure-response relationships for saquinavir, zidovudine and zaltitahine in combination therapy. Antimicrobial Agents Chemother 1997; 41: 2433-8
17. 17. Kline MW, Fletcher CV, Brundage RC, et al. Combination therapy with saquinavir soft gelatin capsules plus nucleoside antiretroviral agents in HIV-infected children. 12th World AIDS Conference; 1998 Jun 28-Jul 3; Geneva