Search tips
Search criteria 


Logo of jcmPermissionsJournals.ASM.orgJournalJCM ArticleJournal InfoAuthorsReviewers
J Clin Microbiol. 1993 October; 31(10): 2557–2564.
PMCID: PMC265936

Use of virologic assays for detection of human immunodeficiency virus in clinical trials: recommendations of the AIDS Clinical Trials Group Virology Committee.

Full text

Full text is available as a scanned copy of the original print version. Get a printable copy (PDF file) of the complete article (1.9M), or click on a page image below to browse page by page. Links to PubMed are also available for Selected References.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.
  • Aoki-Sei S, Yarchoan R, Kageyama S, Hoekzema DT, Pluda JM, Wyvill KM, Broder S, Mitsuya H. Plasma HIV-1 viremia in HIV-1 infected individuals assessed by polymerase chain reaction. AIDS Res Hum Retroviruses. 1992 Jul;8(7):1263–1270. [PubMed]
  • Bollinger RC, Jr, Kline RL, Francis HL, Moss MW, Bartlett JG, Quinn TC. Acid dissociation increases the sensitivity of p24 antigen detection for the evaluation of antiviral therapy and disease progression in asymptomatic human immunodeficiency virus-infected persons. J Infect Dis. 1992 May;165(5):913–916. [PubMed]
  • Borkowsky W, Krasinski K, Pollack H, Hoover W, Kaul A, Ilmet-Moore T. Early diagnosis of human immunodeficiency virus infection in children less than 6 months of age: comparison of polymerase chain reaction, culture, and plasma antigen capture techniques. J Infect Dis. 1992 Sep;166(3):616–619. [PubMed]
  • Bruisten SM, Koppelman MH, Dekker JT, Bakker M, de Goede RE, Roos MT, de Wolf F, Coutinho RA, Goudsmit J, Huisman HG. Concordance of human immunodeficiency virus detection by polymerase chain reaction and by serologic assays in a Dutch cohort of seronegative homosexual men. J Infect Dis. 1992 Sep;166(3):620–622. [PubMed]
  • Burke DS, Fowler AK, Redfield RR, Dilworth S, Oster CN. Isolation of HIV-1 from the blood of seropositive adults: patient stage of illness and sample inoculum size are major determinants of a positive culture. The Walter Reed Retroviral Research Group. J Acquir Immune Defic Syndr. 1990;3(12):1159–1167. [PubMed]
  • Chaisson RE, Leuther MD, Allain JP, Nusinoff-Lehrman S, Boone GS, Feigal D, Volberding P. Effect of zidovudine on serum human immunodeficiency virus core antigen levels. Results from a placebo-controlled trial. Arch Intern Med. 1988 Oct;148(10):2151–2153. [PubMed]
  • Coombs RW, Collier AC, Allain JP, Nikora B, Leuther M, Gjerset GF, Corey L. Plasma viremia in human immunodeficiency virus infection. N Engl J Med. 1989 Dec 14;321(24):1626–1631. [PubMed]
  • Coombs RW, Henrard DR, Mehaffey WF, Gibson J, Eggert E, Quinn TC, Phillips J. Cell-free plasma human immunodeficiency virus type 1 titer assessed by culture and immunocapture-reverse transcription-polymerase chain reaction. J Clin Microbiol. 1993 Aug;31(8):1980–1986. [PMC free article] [PubMed]
  • Defer C, Agut H, Garbarg-Chenon A, Moncany M, Morinet F, Vignon D, Mariotti M, Lefrère JJ. Multicentre quality control of polymerase chain reaction for detection of HIV DNA. AIDS. 1992 Jul;6(7):659–663. [PubMed]
  • Eron JJ, Gorczyca P, Kaplan JC, D'Aquila RT. Susceptibility testing by polymerase chain reaction DNA quantitation: a method to measure drug resistance of human immunodeficiency virus type 1 isolates. Proc Natl Acad Sci U S A. 1992 Apr 15;89(8):3241–3245. [PubMed]
  • Fischl MA, Richman DD, Hansen N, Collier AC, Carey JT, Para MF, Hardy WD, Dolin R, Powderly WG, Allan JD, et al. The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection. A double-blind, placebo-controlled trial. The AIDS Clinical Trials Group. Ann Intern Med. 1990 May 15;112(10):727–737. [PubMed]
  • Gupta P, Enrico A, Armstrong J, Doerr M, Ho M, Rinaldo C. A semiquantitative microassay for measurement of relative number of blood mononuclear cells infected with human immunodeficiency virus. AIDS Res Hum Retroviruses. 1990 Oct;6(10):1193–1196. [PubMed]
  • Ho DD, Moudgil T, Alam M. Quantitation of human immunodeficiency virus type 1 in the blood of infected persons. N Engl J Med. 1989 Dec 14;321(24):1621–1625. [PubMed]
  • Hollinger FB, Bremer JW, Myers LE, Gold JW, McQuay L. Standardization of sensitive human immunodeficiency virus coculture procedures and establishment of a multicenter quality assurance program for the AIDS Clinical Trials Group. The NIH/NIAID/DAIDS/ACTG Virology Laboratories. J Clin Microbiol. 1992 Jul;30(7):1787–1794. [PMC free article] [PubMed]
  • Holodniy M, Katzenstein DA, Israelski DM, Merigan TC. Reduction in plasma human immunodeficiency virus ribonucleic acid after dideoxynucleoside therapy as determined by the polymerase chain reaction. J Clin Invest. 1991 Nov;88(5):1755–1759. [PMC free article] [PubMed]
  • Jackson JB, Balfour HH., Jr Practical diagnostic testing for human immunodeficiency virus. Clin Microbiol Rev. 1988 Jan;1(1):124–138. [PMC free article] [PubMed]
  • Jackson JB, Coombs RW, Sannerud K, Rhame FS, Balfour HH., Jr Rapid and sensitive viral culture method for human immunodeficiency virus type 1. J Clin Microbiol. 1988 Jul;26(7):1416–1418. [PMC free article] [PubMed]
  • Jackson JB, Kwok SY, Sninsky JJ, Hopsicker JS, Sannerud KJ, Rhame FS, Henry K, Simpson M, Balfour HH., Jr Human immunodeficiency virus type 1 detected in all seropositive symptomatic and asymptomatic individuals. J Clin Microbiol. 1990 Jan;28(1):16–19. [PMC free article] [PubMed]
  • Jackson JB, Ndugwa C, Mmiro F, Kataaha P, Guay L, Dragon EA, Goldfarb J, Olness K. Non-isotopic polymerase chain reaction methods for the detection of HIV-1 in Ugandan mothers and infants. AIDS. 1991 Dec;5(12):1463–1467. [PubMed]
  • Japour AJ, Mayers DL, Johnson VA, Kuritzkes DR, Beckett LA, Arduino JM, Lane J, Black RJ, Reichelderfer PS, D'Aquila RT, et al. Standardized peripheral blood mononuclear cell culture assay for determination of drug susceptibilities of clinical human immunodeficiency virus type 1 isolates. The RV-43 Study Group, the AIDS Clinical Trials Group Virology Committee Resistance Working Group. Antimicrob Agents Chemother. 1993 May;37(5):1095–1101. [PMC free article] [PubMed]
  • Jurriaans S, Dekker JT, de Ronde A. HIV-1 viral DNA load in peripheral blood mononuclear cells from seroconverters and long-term infected individuals. AIDS. 1992 Jul;6(7):635–641. [PubMed]
  • Kageyama S, Yamada O, Mohammad SS, Hama S, Hattori N, Asanaka M, Nakayama E, Matsumoto T, Higuchi F, Kawatani T, et al. An improved method for the detection of HIV antigen in the blood of carriers. J Virol Methods. 1988 Dec;22(2-3):125–131. [PubMed]
  • Kahn JO, Lagakos SW, Richman DD, Cross A, Pettinelli C, Liou SH, Brown M, Volberding PA, Crumpacker CS, Beall G, et al. A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. The NIAID AIDS Clinical Trials Group. N Engl J Med. 1992 Aug 27;327(9):581–587. [PubMed]
  • Katzenstein DA, Holodniy M, Israelski DM, Sengupta S, Mole LA, Bubp JL, Merigan TC. Plasma viremia in human immunodeficiency virus infection: relationship to stage of disease and antiviral treatment. J Acquir Immune Defic Syndr. 1992;5(2):107–112. [PubMed]
  • Kestens L, Hoofd G, Gigase PL, Deleys R, van der Groen G. HIV antigen detection in circulating immune complexes. J Virol Methods. 1991 Jan;31(1):67–76. [PubMed]
  • Kozal MJ, Shafer RW, Winters MA, Katzenstein DA, Merigan TC. A mutation in human immunodeficiency virus reverse transcriptase and decline in CD4 lymphocyte numbers in long-term zidovudine recipients. J Infect Dis. 1993 Mar;167(3):526–532. [PubMed]
  • Kwok S, Higuchi R. Avoiding false positives with PCR. Nature. 1989 May 18;339(6221):237–238. [PubMed]
  • Kwok S, Mack DH, Mullis KB, Poiesz B, Ehrlich G, Blair D, Friedman-Kien A, Sninsky JJ. Identification of human immunodeficiency virus sequences by using in vitro enzymatic amplification and oligomer cleavage detection. J Virol. 1987 May;61(5):1690–1694. [PMC free article] [PubMed]
  • Larder BA, Darby G, Richman DD. HIV with reduced sensitivity to zidovudine (AZT) isolated during prolonged therapy. Science. 1989 Mar 31;243(4899):1731–1734. [PubMed]
  • McRae B, Lange JA, Ascher MS, de Wolf F, Sheppard HW, Goudsmit J, Allain JP. Immune response to HIV p24 core protein during the early phases of human immunodeficiency virus infection. AIDS Res Hum Retroviruses. 1991 Aug;7(8):637–643. [PubMed]
  • Miles SA, Balden E, Magpantay L, Wei L, Leiblein A, Hofheinz D, Toedter G, Stiehm ER, Bryson Y. Rapid serologic testing with immune-complex-dissociated HIV p24 antigen for early detection of HIV infection in neonates. Southern California Pediatric AIDS Consortium. N Engl J Med. 1993 Feb 4;328(5):297–302. [PubMed]
  • Mohri H, Singh MK, Ching WT, Ho DD. Quantitation of zidovudine-resistant human immunodeficiency virus type 1 in the blood of treated and untreated patients. Proc Natl Acad Sci U S A. 1993 Jan 1;90(1):25–29. [PubMed]
  • Nishanian P, Huskins KR, Stehn S, Detels R, Fahey JL. A simple method for improved assay demonstrates that HIV p24 antigen is present as immune complexes in most sera from HIV-infected individuals. J Infect Dis. 1990 Jul;162(1):21–28. [PubMed]
  • Ou CY, McDonough SH, Cabanas D, Ryder TB, Harper M, Moore J, Schochetman G. Rapid and quantitative detection of enzymatically amplified HIV-1 DNA using chemiluminescent oligonucleotide probes. AIDS Res Hum Retroviruses. 1990 Nov;6(11):1323–1329. [PubMed]
  • Palomba E, Gay V, de Martino M, Fundaró C, Perugini L, Tovo PA. Early diagnosis of human immunodeficiency virus infection in infants by detection of free and complexed p24 antigen. J Infect Dis. 1992 Feb;165(2):394–395. [PubMed]
  • Reddy MM, Winger EE, Hargrove D, McHugh T, McKinley GF, Grieco MH. An improved method for monitoring efficacy of anti-retroviral therapy in HIV-infected individuals: a highly sensitive HIV p24 antigen assay. J Clin Lab Anal. 1992;6(3):125–129. [PubMed]
  • Saag MS, Crain MJ, Decker WD, Campbell-Hill S, Robinson S, Brown WE, Leuther M, Whitley RJ, Hahn BH, Shaw GM. High-level viremia in adults and children infected with human immunodeficiency virus: relation to disease stage and CD4+ lymphocyte levels. J Infect Dis. 1991 Jul;164(1):72–80. [PubMed]
  • Schnittman SM, Psallidopoulos MC, Lane HC, Thompson L, Baseler M, Massari F, Fox CH, Salzman NP, Fauci AS. The reservoir for HIV-1 in human peripheral blood is a T cell that maintains expression of CD4. Science. 1989 Jul 21;245(4915):305–308. [PubMed]
  • Simmonds P, Balfe P, Peutherer JF, Ludlam CA, Bishop JO, Brown AJ. Human immunodeficiency virus-infected individuals contain provirus in small numbers of peripheral mononuclear cells and at low copy numbers. J Virol. 1990 Feb;64(2):864–872. [PMC free article] [PubMed]
  • Spector SA, Kennedy C, McCutchan JA, Bozzette SA, Straube RG, Connor JD, Richman DD. The antiviral effect of zidovudine and ribavirin in clinical trials and the use of p24 antigen levels as a virologic marker. J Infect Dis. 1989 May;159(5):822–828. [PubMed]
  • Tudor-Williams G, St Clair MH, McKinney RE, Maha M, Walter E, Santacroce S, Mintz M, O'Donnell K, Rudoll T, Vavro CL, et al. HIV-1 sensitivity to zidovudine and clinical outcome in children. Lancet. 1992 Jan 4;339(8784):15–19. [PubMed]
  • Venet A, Lu W, Beldjord K, Andrieu JM. Correlation between CD4 cell counts and cellular and plasma viral load in HIV-1-seropositive individuals. AIDS. 1991 Mar;5(3):283–288. [PubMed]
  • Volberding PA, Lagakos SW, Koch MA, Pettinelli C, Myers MW, Booth DK, Balfour HH, Jr, Reichman RC, Bartlett JA, Hirsch MS, et al. Zidovudine in asymptomatic human immunodeficiency virus infection. A controlled trial in persons with fewer than 500 CD4-positive cells per cubic millimeter. The AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases. N Engl J Med. 1990 Apr 5;322(14):941–949. [PubMed]
  • Whetsell AJ, Drew JB, Milman G, Hoff R, Dragon EA, Adler K, Hui J, Otto P, Gupta P, Farzadegan H, et al. Comparison of three nonradioisotopic polymerase chain reaction-based methods for detection of human immunodeficiency virus type 1. J Clin Microbiol. 1992 Apr;30(4):845–853. [PMC free article] [PubMed]
  • Wolinsky SM, Rinaldo CR, Kwok S, Sninsky JJ, Gupta P, Imagawa D, Farzadegan H, Jacobson LP, Grovit KS, Lee MH, et al. Human immunodeficiency virus type 1 (HIV-1) infection a median of 18 months before a diagnostic western blot. Evidence from a cohort of homosexual men. Ann Intern Med. 1989 Dec 15;111(12):961–972. [PubMed]
  • Yerly S, Chamot E, Hirschel B, Perrin LH. Quantitation of human immunodeficiency virus provirus and circulating virus: relationship with immunologic parameters. J Infect Dis. 1992 Aug;166(2):269–276. [PubMed]

Articles from Journal of Clinical Microbiology are provided here courtesy of American Society for Microbiology (ASM)