Toxicity and drug exposure in a quadruple drug regimen in HIV-1 infected patients participating in the ADAM study

AIDS

Volumn 14, Issue 1, 2000, Pages 59-68

  Reijers, Monique H E ^a,b   Weigel, Hugo M ^b   Hart, Augustinus A M ^a   Ten Kate, Reinier W ^b   Mulder, Jan Willem ^c   Reiss, Peter ^a   Schuitemaker, Hanneke ^d   Hoetelmans, Richard M W ^c   Weverling, Gerrit Jan ^a   Lange, Joep M A ^a  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b Onze Lieve Vrouwe Gasthuis ^*  (Netherlands)

^c SLOTERVAART HOSPITAL   (Netherlands)

^d CENTRAL LABORATORY   (Netherlands)

Author keywords

Antiretroviral therapy; Drug exposure; Nelfinavir; Protease inhibitors; Saquinavir; Toxicity

Indexed keywords

ANTIDIARRHEAL AGENT; CHOLESTEROL; LAMIVUDINE; LIVER ENZYME; LOPERAMIDE; NELFINAVIR; PROTEINASE INHIBITOR; SAQUINAVIR; STAVUDINE; TRIACYLGLYCEROL;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; ARTICLE; CHOLESTEROL BLOOD LEVEL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG TOXICITY; FATIGUE; FEASIBILITY STUDY; FEMALE; GLUCOSURIA; HEADACHE; HUMAN; HUMAN CELL; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYPERGLYCEMIA; HYPERTRIGLYCERIDEMIA; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; NAUSEA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TRIACYLGLYCEROL BLOOD LEVEL;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ADULT; ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; DIARRHEA; DRUG THERAPY, COMBINATION; FEMALE; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; LAMIVUDINE; LIVER; MALE; MIDDLE AGED; NAUSEA; NELFINAVIR; REVERSE TRANSCRIPTASE INHIBITORS; SAQUINAVIR; STAVUDINE;

EID: 0033967796     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002030-200001070-00007     Document Type: Article

References (34)

1. 1. Gulick RM, Mellors JW, Havlir D, et al. Treatment with indinavir, zidovudine, and lamivudine in adults with human immunodeficiency virus infection and prior antiretroviral therapy. N Engl J Med 1997, 337:734-739.
2. 2. Hammer SM, Squires KE, Hughes MD, et al. A controlled trial of two 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, 337:724-733.
3. 3. Montaner JSC, Reiss P, Cooper D, et al. A randomized, double-blinded trial comparing combinations of nevirapine, didanosine and zidovudine for HIV infected patients - the INCAS trial. JAMA 1998, 279:930-937.
4. 4. Palella FJ, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 1998, 338:853-860.
5. 5. Mouton Y, Alfandari S, Valette M, et al. Impact of protease inhibitors on AIDS defining events and hospitalization in 10 French AIDS reference centres: Federation National des Centres de lutte contre le SIDA. AIDS 1997, 11:F101-F105.
6. 6. Kempf DJ, Rode RA, Xu Y, et al. The duration of viral suppression during protease inhibitor therapy for HIV-1 infection is predicted by plasma HIV-1 RNA at the nadir. AIDS 1998, 12:F9-F14.
7. 7. Raboud JM, Montaner JSC, Conway B, et al. Suppression of plasma viral load below 20 copies/ml is required to achieve a long-term response to therapy. AIDS 1998, 12:1619-1624.
8. 8. Weverling GJ, Lange JMA, Jurriaans S, et al. Alternative multidrug regimen provides improved suppression of HIV-1 replication over triple therapy. AIDS 1998, 12:F117-F122.
9. 9. Hoetelmans RMW, Reijers MHE, Weverling GJ, et al. The effect of plasma drug concentrations on HIV-1 clearance rate during quadruple drug therapy. AIDS 1998, 12.F111-F115.
10. 10. Lange JMA, Richman DD. The limitations of simplicity. Antiretroviral Ther 1998, 3:4-5.
11. 11. Montaner JSC, Hogg R, Raboud J, Harrigan R, O'Shaughnessy M. Antiretroviral treatment in 1998. Lancet 1998, 352:1919-1922.
12. 12. Merry C, Barry MG, Mulcahy F, et al. Saquinavir pharmacokinetics alone and in combination with ritonavir in HIV-infected patients. AIDS 1997, 11:F29-F33.
13. 13. Merry C, Barry MC, Mulcahy F, et al. Saquinavir pharmacokinetics alone and in combination with nelfinavir in HIV-1 infected patients. AIDS 1997, 11:F117-F120.
14. 14. Carr A, Samaras K, Burton S, Freund J, Chisholm DJ, Cooper DA. A syndrome of peripheral lipodystrophy, hyperlipidemia and insulin resistance in patients receiving HIV protease inhibitors. AIDS 1998; 12:F51-F58.
15. 15. Deeks SC, Smith M, Holodnly M, Kahn JC. HIV-1 Protease Inhibitors. A review for clinicians. JAMA 1997, 277:145-153.
16. 16. Flexner C. HIV-Protcase Inhibitors. N Engl J Med 1998, 338: 1281-1291.
17. 17. Kaufmann CR, Duncombe C, Cunningham P, et al. Treatment response and durability of a double protease inhibitor therapy with Saquinavir and ritonavir in an observational cohort of HIV-1 infected individuals. AIDS 1998, 12:1625-1630.
18. 18. Rhone SA, Hogg RS, Yip B, et al. The antiretroviral effect of ritonavir and Saquinavir in combination amongst HIV-infected adults: results from a community-based study. AIDS 1998, 12:619-624.
19. 19. Lorenzi P, Yerly S, Abderrakim K, et al. Toxicity, efficacy, plasma drug concentrations and protease mutations in patients with advanced HIV infection treated with ritonavir plus saquinavir. AIDS 1997, 11:F95-F99.
20. 20. Reijers MHE, Weverling GJ, Jurriaans S, et al. Maintenance therapy after quadruple induction therapy in HIV-1 infected individuals: Amsterdam Duration of Antiretroviral Medication (ADAM) study. Lancet 1998, 352:185-190.
21. 21. World Health Organisation. WHO handbook for reporting results of cancer treatment. Geneva: WHO, 1979.
22. 22. Guidelines for grading of toxicity of the ACTG. AIDS Clinical Trial Group, Rockville, Maryland, USA, 1997.
23. 23. Hoetelmans RMW, Van Essenberg M, Meenhorst PL, et al. Determination of saquinavir in human plasma, saliva, and cerebrospinal fluid by ion-pair high-performance liquid chromatography with ultraviolet detection. J Chrom B 1997, 698:235-241.
24. 24. Hoetelmans RMW, Reijers MHE, van Heeswijk RFG, et al. Saquinavir (SQV) pharmacokinetics in combination with nelfinavir (NFV) in the ADAM study. 6th European Conference on Clinical Aspects of HIV-infection. Hamburg, October 1997 [abstract 255].
25. 25. Zeger SL Liang KY. Longitudinal data analysis using generalized linear models. The analysis of discrete and continuous longitudinal data. Biometrics 1986, 42:121-130.
26. 26. Centers for Disease Control. 1993 Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR 1992, 41 (RR-17): 1-19.
27. 27. Slater I, Sension M, Feinberg J, Poblete R, Siemon P, Pilson R. Fortovase BID regimens in HIV-1 infected patients: combination with 2 nucleoside analogs or with nelfinavir plus 1 nucleoside analog. 6th Conference on Retroviruses and Opportunistic Infections. January 1999 [abstract 390].
28. 28. Movie G. Study of protease inhibitors combination in Europe (SPICE): Saquinavir Soft Gelatin Capsule (SQV-SGC, Fortovase TM and Nelfinavir (NFV) in HIV infected individuals. 12th World AIDS Conference., Geneva, June 1098 [abstract 12222].
29. 29. Khaliq Y, Gallicano K, Sahai J, et al. Effect of nelfinavir (NFV) on short and long term plasma exposure of saquinavir in hard gel capsule (SQV-HGC) during TID and BID dosing regimens. AIDS 1998, 12:[abstract S28].
30. 30. Mitsuyasu R, Skolnik P, Cohen S, et al. Activity of the soft gelatin formulation of saquinavir in combination therapy in antiretroviral-naïve patients. NV1S355 study Team. AIDS 1998, 12: F103-F109.
31. 31. Roche. Fortovase (saquinavir) soft gelatin capsules product monograph. Nutley, NJ: Roche Laboratories; 1997 (package insert).
32. 32. Moyle GL, Youle M, Higgs C, et al. Extended follow-up of the safety and activity of Agouron's HIV protease inhibitors AG1343 (Viracept) in virological responders form the UK phase I/II dose finding study. Volume 1 of Program and abstracts of the 11th International Conference on AIDS. Vancouver, July 1996 [abstract 25].
33. 33. Agouron Pharmaceutical. Viracept (nelfinavir mesylate) tablets and oral powder product monograph. La Jolla, CA: Agouron Pharmaceuticals; 1997 (package insert).
34. 34. Roche. Invirase (saquinavir mesylate) capsules product monograph. Nutley, NJ: Roche Laboratories; 1997 (package insert).