A randomized controlled trial of a protease inhibitor (saquinavir) in combination with zidovudine in previously untreated patients with advanced HIV infection

Antiviral Therapy

Volumn 1, Issue 3, 1996, Pages 129-140

  Vella, Stefano ^a   Lazzarin, Adriano ^b   Carosi, Giampiero ^c   Sinicco, Alessandro ^d   Armignacco, Orlando ^e   Angarano, Gioacchino ^f   Andreoni, Massimo ^g   Tambussi, Giuseppe ^b   Chiodera, Alessandro ^c   Floridia, Marco ^a   Scaccabarozzi, Sergio ^h   Facey, Karen ^i,k   Duncan, Ian ⁱ   Boudes, Pol ^j,l   Bragman, Keith ^j,m  

^a ISTITUTO SUPERIORE DI SANITÀ   (Italy)

^b SAN RAFFAELE HOSPITAL   (Italy)

^c UNIVERSITY OF BRESCIA   (Italy)

^d UNIVERSITY OF TURIN   (Italy)

^e NATIONAL INSTITUTE FOR INFECTIOUS DISEASES L SPALLANZANI   (Italy)

^f UNIVERSITY OF BARI   (Italy)

^g UNIVERSITY OF ROME TOR VERGATA   (Italy)

^h ROCHE MILANO RICERCHE   (Italy)

ⁱ ROCHE PRODUCTS LTD   (United Kingdom)

^j International Clinical Research Unit   (France)

^k MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

^l Wyeth Ayerst Research European CR and D Department   (France)

^m IQVIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; GAG PROTEIN; PROTEINASE INHIBITOR; SAQUINAVIR; VIRUS RNA; ZIDOVUDINE;

ADULT; ARTICLE; BLOOD; CD4 LYMPHOCYTE COUNT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG COMBINATION; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOLOGY; MALE; MIDDLE AGED; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; VIROLOGY;

ADULT; ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HIV CORE PROTEIN P24; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HUMANS; MALE; MIDDLE AGED; RNA, VIRAL; SAQUINAVIR; ZIDOVUDINE;

EID: 0030201562     PISSN: 13596535     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (23)

1. Ho DD, Neumann AU, Perelson AS, Chen W, Leonard JM & Markowitz M. Rapid turnover of plasma virions and CD4 lymphocytes in HIV-1 infection. Nature 1995; 373:123-126.
2. Fauci AS. Multifactorial nature of human immunodeficiency virus disease: implications for therapy. Science 1993; 262:1011-1018.
3. Richman DD, Grimes JM & Lagakos SW. Effect of stage of disease and drug dose on zidovudine susceptibilities of isolates of human immunodeficiency virus. Journal of Acquired Immune Deficiency Syndromes 1990; 3:743-746.
4. Richman DD. Resistance of clinical isolates of human immunodeficiency virus to antiretroviral agents. Antimicrobial Agents and Chemotherapy 1991; 37:1207-1213.
5. Meng T-C, Fischl MA, Boota AM, Spector SA, Bennett D, Bassiakos Y, Lai S, Wright B & Richman DD. Combination therapy with zidovudine and dideoxycytidine in patients with advanced human immunodeficiency virus infection. Annals of Internal Medicine 1992; 116:13-20.
6. Groopman JE. The challenge of combination antiviral therapy for AIDS. American Journal of Medicine 1991; 90:15.
7. Collier AC, Coombs RW, Fischl MA, Skolnik PR, Northfelt D, Boutin P, Hooper CJ, Kaplan LD, Volberding PA & Davis LG. Combination therapy with zidovudine and didanosine compared with zidovudine alone in HIV-1 infection. Annals of Internal Medicine 1993; 119:786-793.
8. Yarchoan R, Lietzau JA, Nguyen B-Y, Brawley OW, Pluda JM, Saville MW, Wyvill KM, Steinberg SM, Agbaria R & Mitsuya H. A randomised pilot study of alternating or simultaneous zidovudine and didanosine therapy in patients with symptomatic human immunodeficiency virus infection. Journal of Infectious Disease 1994; 169:9-17.
9. De Clercq E. Basic approaches to anti-retroviral treatment. Journal of Acquired Immune Deficiency Syndromes 1991; 4:207-218.
10. Kramer RA, Schaber MD, Skalka AM, Ganguly K, Wong-Staal F & Reddy EP. HTLV III gag protein is processed in yeast cells by the virus pol proteinase. Science 1986; 231:1580-1584.
11. Robins T & Plattner J. HIV proteinase inhibitors: their anti-HIV activity and potential role in treatment. Journal of Acquired Immune Deficiency Syndromes 1993; 6:162-170.
12. Roberts NA, Martin JA, Kinchington D, Broadhurst AV, Craig JC, Duncan IB, Galpin SA, Handa BK, Kay J, Krohn A, Lambert RW, Merrett JH, Mills JS, Parkes KEB, Redshaw S, Ritchie AJ, Taylor DL, Thomas GJ & Machin PJ. Rational design of peptide based HIV proteinase inhibitors. Science 1990; 248:358-361
13. Craig JC, Duncan IB, Hockley D, Grief C, Roberts NA & Mills JS. Antiviral properties of Ro-31-8959, an inhibitor of human immunodeficiency virus (HIV) proteinase. Antiviral Research 1991; 16:295-305.
14. Roberts NA & Redshaw S. Discovery and development of the HIV proteinase inhibitor Ro 31-8959. In The Search for Antiviral Drugs. Edited by J Adams & VJ Merluzzi 1993; pp 129-151. Boston: Birkhauser.
15. Johnson VA, Merrill P, Chou T-C & Hirsch MS. Human immunodeficiency virus type 1 (HIV-1) inhibitory interactions between proteinase inhibitor Ro 31-8959 and zidovudine, 2′,3′-dideoxycytidine, or recombinant interferon alfa against zidovudine-sensitive or resistant HIV-1 in vitro. Journal of Infectious Disease 1992; 166:1143-1146.
16. Craig JC, Duncan IB, Whittaker L & Roberts NA. Antiviral synergy between inhibitors of HIV proteinase and reverse transcriptase. Antiviral Chemistry & Chemotherapy 1990; 40:161-166.
17. 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. Journal of Clinical Microbiology 1994; 32:292-300.
18. Japour AJ, Mayers DL, Johnson VA, Kuritzkes DR, Beckett LA, Arduino JM, Lane J, Black RJ, Reichelderfer PS, D'Aquila RT, Crumpacker CS, The RV-43 Study Group & The AIDS Clinical Trials Group Virology Committee Resistance Working Group. Standardized peripheral blood mononuclear cell culture assay for determination of drug susceptibilities of clinical human immunodeficiency virus type 1 isolates. Antimicrobial Agents and Chemotherapy 1993; 37:1095-1101.
19. Muirhead GJ, Shaw T, Williams PEO, Madigan MJ, Mitchell AM & Houston AC. Pharmacokinetics of the HIV-proteinase inhibitor, Ro 31-8959, after single and multiple oral doses in healthy volunteers. British Journal of Clinical Pharmacology 1992; 34:170p.
20. Schapiro JM, Winters MA, Stewart F, Efron B, Norris J, Kozal MJ & Merigan TC. The effect of high-dose saquinavir on viral load and CD4+ T-cell counts in HIV-infected patients. Annals of Internal Medicine 1996; 124:1039-1050.
21. Kitchen VS, Skinner C, Ariyoshi K, Lane EA, Duncan IB, Burckhardt J, Burger HU, Bragman K, Pinching AJ & Weber JN. Safety and activity of saquinavir in HIV infection. Lancet 1995; 345:952-955
22. Salgo MP, Beattie D, Bragman K, Donatacci L, Jones M, Montgomery L & The NV 14256 Study Team. Saquinavir (Invirase, SQV) vs Hivid (zalcitabine, ddC) vs combination as treatment for advanced HIV infection in patients discontinuing/ unable to take Retrovir (zidovudine, ZDV). XIth International Conference on AIDS, Vancouver, Canada, 7-12 July 1996. Abstr. Mo.B.410.
23. Collier AC, Coombs RW, Schoenfeld DA, Bassett RL, Timpone J, Baruch A, Jones M, Facey K, Whitacre C, McAuliffe VJ, Friedman HM, Merigan TC, Reichman RC, Hooper C & Corey L for The AIDS Clinical Trials Group. Treatment of human immunodeficiency virus infection with saquinavir, zidovudine and zalcitabine. New England Journal of Medicine 1996; 334:1011-1017.