The effects of protease inhibitor therapy on human immunodeficiency virus type 1 levels in semen (AIDS Clinical Trials Group Protocol 850)

Journal of Infectious Diseases

Volumn 181, Issue 5, 2000, Pages 1622-1628

  Eron Jr , Joseph J ^a   Smeaton, Laura M ^c   Fiscus, Susan A ^a   Gulick, Roy M ^f   Currier, Judith S ⁱ   Lennox, Jeffrey L ^g   D'Aquila, Richard T ^d   Rogers, Michael D ^b   Tung, Roger ^e   Murphy, Robert L ^h  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^b GLAXOSMITHKLINE   (United States)

^c HARVARD UNIVERSITY   (United States)

^d MASSACHUSETTS GENERAL HOSPITAL   (United States)

^e VERTEX PHARMACEUTICALS   (United States)

^f NEW YORK UNIVERSITY   (United States)

^g EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^h NORTHWESTERN UNIVERSITY   (United States)

ⁱ UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMPRENAVIR; ANTIRETROVIRUS AGENT; LAMIVUDINE; PROTEINASE INHIBITOR; VIRUS RNA; ZIDOVUDINE;

ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEMEN ANALYSIS; SEMINAL PLASMA; SEXUALLY TRANSMITTED DISEASE; VIRUS REPLICATION; VIRUS RESISTANCE; VIRUS SHEDDING; VIRUS TRANSMISSION;

ADULT; CARBAMATES; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; LAMIVUDINE; MALE; MIDDLE AGED; REGRESSION ANALYSIS; RNA, VIRAL; SEMEN; SULFONAMIDES; VIRUS SHEDDING; ZIDOVUDINE;

EID: 0034129970     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1086/315447     Document Type: Article

References (35)

1. 1. Gulick R, Mellors J, Havlir D, et al. Simultaneous vs. sequential initiation of therapy with indinavir, zidovudine, and lamivudine for HIV-1 infection: 100 week follow-up. JAMA 1998;280:35-41.
2. 2. Palella FJ Jr, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. N Engl J Med 1998;338:853-60.
3. 3. Royce R, Sena A, Cates W Jr, Cohen M. Current concepts: sexual transmission of HIV. N Engl J Med 1997;336:1072-9.
4. 4. Gupta P, Mellors J, Kingsley L, et al. High viral load in semen of human immunodeficiency virus type I-infected men at all stages of disease and its reduction by therapy with protease and nonnucleoside reverse transcriptase inhibitors. J Virol 1997;71:6271-5.
5. 5. Gilliam BL, Dyer JR, Fiscus SA, et al. Effects of reverse transcriptase inhibitor therapy on the HIV-1 viral burden in semen. J Acquir Immune Defic Syndr Hum Retrovirul 1997;15:54-60.
6. 6. Vernazza PL, Gilliam BL, Flepp M, et al. Effect of antiviral treatment on the shedding of HIV-1 in semen. AIDS 1997;11:1249-54.
7. 7. Eron J, Vernazza P, Johnston D, et al. Resistance of HIV-1 to antiretroviral agents in blood and seminal plasma: implications for transmission. AIDS 1998;12:F181-9.
8. 8. Delwart EL, Mullins JI, Gupta P, et al. Human immunodeficiency virus type I populations in blood and semen. J Virol 1998;72:617-23.
9. 9. Byrn RA, Zhang D, Eyre R, McGowan K, Kiessling, AA. HIV-1 in semen: an isolated virus reservoir. Lancet 1997;350:1141.
10. 10. Vernazza PL, Eron JJ, Cohen MS, van der Horst CM, Troiani L, Fiscus SA. Detection and biologic characterization of infectious HIV-1 in semen of seropositive men. AIDS 1994;8:1325-9.
11. 11. Pereira A, Kashuba A, Fiscus S, et al. Nucleoside analogues achieve high concentrations in seminal plasma: relationship between drug concentrations and viral burden. J Infect Dis 1999;180:2039-43.
12. 12. Taylor S, Back D, Workman J, et al. Poor penetration of the male genital tract by HIV-1 protease inhibitors. AIDS 1999;13:859-60.
13. 13. Kashuba A, Dyer J, Kramer L, Raasch R, Eron J, Cohen M. Antiretroviral drug concentrations in semen: implications for sexual transmission of human immunodeficiency virus type 1. Antimicrob Agents Chemother 1999; 43:1817-26.
14. 14. Kim EE, Baker CT, Dwyer MD, et al. Crystal structure of HIV-1 protease in complex with VX-478, a potent and orally bioavailable inhibitor of the enzyme. J Am Chem Soc 1995;117:1181-2.
15. 15. St Clair M, Millard J, Rooney J, et al. In vitro antiviral activity of 141W94 (VX-478) in combination with other antiretroviral agents. Antiviral Res 1996;29:53-6.
16. 16. Livington DJ, Pazhanisamy S, Porter DJ, Partaledis JA, Tung RD, Painter GR. Weak binding of VX-478 to human plasma proteins and implications for anti-human immunodeficiency virus therapy. J Infect Dis 1995;172: 1238-45.
17. 1-acid glycoprotein on the anti-human immunodeficiency virus (HIV) activity of the protease inhibitor CGP 61755: a comparative study with other relevant HIV protease inhibitors. J Infect Dis 1997;175:1063-70.
18. 18. Tisdale M, Myers RE, Maschera B, Parry NR, Oliver NM, Blair ED. Cross-resistance analysis of human immunodeficiency virus type 1 variants individually selected for resistance to five different protease inhibitors. Antimicrob Agents Chemother 1995;39:1704-10.
19. 19. Partaledis JA, Yamaguchi K, Tisdale M, et al. In vitro selection and characterization of human immunodeficiency virus type 1 (HIV-1) isolates with reduced sensitivity to hydroxyethylamino sulfonamide inhibitors of HIV-1 aspartyl protease. J Virol 1995;69:5228-35.
20. 1 [abstract late breaker 7A]. In: Programs and abstracts of the 36th Interscience Conference on Antimicrobial Agents and Chemotherapy (New Orleans). Washington, DC: American Society for Microbiology, 1996.
21. 21. Murphy RL, Gulick RM, DeGruttola V, et al. Treatment with amprenavir alone or amprenavir with zidovudine and lamivudine in adults with human immunodeficiency virus infection. J Infect Dis 1999;179:808-16.
22. 22. Dyer J, Gilliam B, Eron J, Grosso L, Cohen M, Fiscus S. Quantitation of HIV-1 RNA in cell-free seminal plasma by NASBA amplification and amplicor reverse transcription PCR: a comparative study. J Virol Methods 1996;60:161-70.
23. 23. van Gemen B, van BR, Nabbe A, et al. A one-tube quantitative HIV-1 RNA NASBA nucleic acid amplification assay using electrochemiluminescent (ECL) labeled probes. J Virol Methods 1994;49:157-67.
24. 24. Yen-Lieberman B, Brambilla D, Jackson B, et al. Evaluation of a quality assurance program for quantitation of human immunodeficiency virus type 1 RNA in plasma by the AIDS Clinical Trials Group virology laboratories. J Clin Microbiol 1996;34:2695-701.
25. 25. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307-10.
26. 26. Marschner IC, Betensky RA, DeGruttola V, Hammer SM, Kuritzkes DR. Clinical trials using HIV-1 RNA-based primary endpoints: statisticalanalysis and potential biases. J Acquir Immune Defic Syndr Hum Retrovirol 1999;20:220-7.
27. 27. Dyer JR, Pilcher CD, Shepard R, Schock J, Eron JJ, Fiscus SA. Comparison of NucliSens and Roche Monitor assays for quantitation of levels of human immunodeficiency virus type 1 RNA in plasma. J Clin Microbiol 1999;37:447-9.
28. 28. Vernazza PL, Gilliam BL, Dyer J, et al. Quantification of HIV in semen: correlation with antiviral treatment and immune status. AIDS 1997;11: 987-93.
29. 29. Cohen MS, Hoffman IF, Royce RA, et al. Reduction of concentration of HIV-1 in semen after treatment of urethritis: implications for prevention of sexual transmission of HIV-1. AIDSCAP Malawi Research Group. Lancet 1997;349:1868-73.
30. 30. Garcia P, Kalish L, Pitt J, et al. Maternal levels of plasma human immunodeficiency virus type 1 RNA and the risk of perinatal transmission. N Engl J Med 1999;341:394-8.
31. 31. Mofenson L, Lambert J, Stiehm E, et al. Risk factors for perinatal transmission of human immunodeficiency virus type 1 in women treated with zidovudine. N Engl J Med 1999;341:385-93.
32. 32. Sperling RS, Shapiro DE, Coombs RW, et al. Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. N Engl J Med 1996;335:1621-9.
33. 33. Lee TH, Sakahara N, Fiebig E, Busch MP, O'Brien TR, Herman SA. Correlation of HIV-1 RNA levels in plasma and heterosexual transmission of HIV-1 from infected transfusion recipients. J Acquir Immune Defic Syndr Hum Retrovirol 1996;12:427-8.
34. 34. Busch M, Operskalski E, Mosley J, et al. Factors influencing human immunodeficiency virus type 1 transmission by blood transfusion. J Infect Dis 1996;174:26-33.
35. 35. Hecht FM, Grant RM, Petropoulos CJ, et al. Sexual transmission of an HIV-1 variant resistant to multiple reverse-transcriptase and protease inhibitors. N Engl J Med 1998;339:307-11.