Blood and seminal plasma HIV-1 RNA levels among HIV-1-infected injecting drug users participating in the AIDSVAX B/E efficacy trial in bangkok, Thailand

Journal of Acquired Immune Deficiency Syndromes

Volumn 51, Issue 5, 2009, Pages 601-608

  Kittikraisak, Wanitchaya ^a,k   Van Griensven, Frits ^a,b   Martin, Michael ^a,b   McNicholl, Janet ^a,b   Gilbert, Peter B ^c   Chuachoowong, Rutt ^a,d   Vanichseni, Suphak ^e   Sutthent, Ruengpung ^d   Tappero, Jordan W ^b   Mastro, Timothy D ^b,j   Hu, Dale J ^b   Gurwith, Marc ^f   Kitayaporn, Dwip ^g,i   Sangkum, Udomsak ^h   Choopanya, Kachit ^e  

^a MINISTRY OF PUBLIC HEALTH   (Thailand)

^b CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

^d MAHIDOL UNIVERSITY   (Thailand)

^e Bangkok Vaccine Evaluation Group   (Thailand)

^f VaxGen Inc   (United States)

^g MAHIDOL UNIVERSITY   (Thailand)

^h Bangkok Metropolitan Administration   (Thailand)

ⁱ BUMRUNGRAD INTERNATIONAL HOSPITAL   (Thailand)

^j FAMILY HEALTH INTERNATIONAL   (United States)

^k NONE   (Thailand)

more..

Author keywords

HIV 1 RNA viral load; HIV 1 vaccine; Injecting drug users

Indexed keywords

AIDSVAX B/E; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; PLACEBO; UNCLASSIFIED DRUG; VIRUS RNA;

ADULT; ARTICLE; CD4 LYMPHOCYTE COUNT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; FOLLOW UP; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; INTRAVENOUS DRUG ABUSE; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEMINAL PLASMA; SEROCONVERSION; STATISTICAL ANALYSIS; THAILAND; VACCINATION; VIREMIA; VIRUS LOAD; VIRUS STRAIN;

ADULT; AIDS VACCINES; DOUBLE-BLIND METHOD; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; LINEAR MODELS; MALE; RNA, VIRAL; SEMEN; SUBSTANCE ABUSE, INTRAVENOUS; THAILAND;

EID: 68449096170     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/QAI.0b013e3181a44700     Document Type: Article

References (40)

1. The Bangkok Vaccine Evaluation Group. Randomized, placebo-controlled efficacy trial of a bivalent rgpl20 HIV-1 vaccine among injecting drug users in Bangkok, Thailand. J Infect Dis. 2006;194:1661-1671.
2. Flynn NM, Forthal DN, Harro CD, et al. Placebo-controlled phase 3 trial of recombinant glycoprotein 120 vaccine to prevent HIV-1 infection. J Infect Dis. 2005;191:654-665.
3. Barouch DH, Santra S, Schmitz JE, et al. Control of viremia and prevention of clinical AIDS in rhesus monkeys by cytokine-augmented DNA vaccination. Science. 2000;290:486-492.
4. Amara RR, Villinger F, Altman JD, et al. Control of a mucosal challenge and prevention of AIDS by a multiprotein DNA/MVA vaccine. Science. 2001;292:69-74.
5. Shiver JW, Fu TM, Chen L, et al. Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature. 2002;415:331-335.
6. Hu DJ, Vitek CR, Bartholow B, et al. Key issues for a potential human immunodeficiency virus vaccine. Clin Infect Dis. 2003;36:638-644.
7. Buchacz K, Hu DJ, Vanichseni S, et al. Early markers of HIV-1 disease progression in a prospective cohort of seroconverters in Bangkok, Thailand: implications for vaccine trials. J Acquir Immune Defic Syndr. 2004;36:853-860.
8. Hu DJ, Vanichseni S, Mastro TD, et al. Viral load differences in early infection with two HIV-1 subtypes. AIDS. 2001;15:683-691.
9. Vanichseni S, Tappero JW, Pitisuttithum P, et al. Recruitment, screening and characteristics of injection drug users participating in the AIDSVAX B/E HIV vaccine trial, Bangkok, Thailand. AIDS. 2004;18:311-316.
10. Ministry of Public Health. National Guidelines for the Clinical Management of HIV Infection in Children and Adults. 6th ed. Nonthaburi, Thailand: Division of AIDS, Department of Communicable Disease Control, Ministry of Public Health; 2000.
11. Ministry of Public Health. Guidelines for the Care and Treatment of HIV/AIDS in Children and Adults in Thailand. 7th ed. Nonthaburi, Thailand: Division of AIDS, Department of Communicable Disease Control, Ministry of Public Health; 2002.
12. Centers for Disease Control and Prevention. 1997 Revised guidelines for performing CD4+ T-cell determinations in persons infected with human immunodeficiency virus (HIV). MMWR Recomm Rep. 1997;46:(RR-2): 1-29.
13. Coombs RW, Speck CE, Hughes JP, et al. Association between culturable human immunodeficiency virus type 1 (HIV-1) in semen and HIV-1 RNA levels in semen and blood: evidence for compartmentalization of HIV-1 between semen and blood. J Infect Dis. 1998;177:320-330.
14. Boom R, Sol CJ, Salimans MM, et al. Rapid and simple method for purification of nucleic acids. J Clin Microbiol. 1990;28:495-503.
15. Lyles RH, Lyles CM, Taylor DJ. Random regression models for human immunodeficiency virus ribonucleic acid data subject to left censoring and informative drop-outs. Appl Stat. 2000;49:485-497.
16. Smith SM, Holland B, Russo C, et al. Retrospective analysis of viral load and SIV antibody responses in rhesus macaques infected with pathogenic SIV: predictive value for disease progression. AIDS Res Hum Retroviruses. 1999;15:1691-1701.
17. Hudgens MG, Hoering A, Self SG. On the analysis of viral load endpoints in HIV vaccine trials. Stat Med. 2003;22:2281-2298.
18. Pearson ES. The choice of statistical test illustrated on the interpretation of data classed in a 2 × 2 table. Biometrika. 1947;34:139-167.
19. Upton GJG. Fisher's exact test. J Roy Statist Soc A. 1992;155:395-402.
20. "Student" (GossetWS). The probable error of a mean. Biometrika. 1908;6:1-25.
21. Cleveland WS. Robust locally weighted regression and smoothing scatterplots. J Am Stat Assoc. 1979;74:829-836.
22. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982;38:963-974.
23. Liang KY, Zeger SL. Longitudinal data analysis using general linear models. Biometrika. 1986;73:13-22.
24. Wilcoxon F. Individual comparisons by ranking methods. Biometrics Bull. 1945;1:80-83.
25. Lunn M, McNeil D. Applying Cox regression to competing risks. Biometrics. 1995;51:524-532.
26. Subbarao S, Limpakarnjanarat K, Mastro TD, et al. HIV type 1 in Thailand, 1994-1995: persistence of two subtypes with low genetic diversity. AIDS Res Hum Retroviruses. 1998;14:319-327.
27. Subbarao S, Vanichseni S, Hu DJ, et al. Genetic characterization of incident HIV type 1 subtype E and B strains from a prospective cohort of injecting drug users in Bangkok, Thailand. AIDS Res Hum Retroviruses. 2000;16:699-707.
28. Kivela PS, Krol A, Salminen MO, et al. High plasma HIV load in the CRF01-AE outbreak among injecting drug users in Finland. Scand J Infect Dis. 2005;37:276-283.
29. Gilbert PB, Bosch RJ, Hudgens MG. Sensitivity analysis for the assessment of causal vaccine effects on viral load in HIV vaccine trials. Biometrics. 2003;59:531-541.
30. Modjarrad K, Chamot E, Vermund SH. Impact of small reductions in plasma HIV RNA levels on the risk of heterosexual transmission and disease progression. AIDS. 2008;22:2179-2185.
31. Chakraborty H, Sen PK, Helms RW, et al. Viral burden in genital secretions determines male-to-female sexual transmission of HIV-1: a probabilistic empiric model. AIDS. 2001;15:621-627.
32. Gupta SB, Jacobson LP, Margolick JB, et al. Estimating the benefit of an HIV-1 vaccine that reduces viral load set point. J Infect Dis. 2007;195:546-550.
33. Excler JL, Rida W, Priddy F, et al. A strategy for accelerating the development of preventive AIDS vaccines. AIDS. 2007;21:2259-2263.
34. Buge SL, Ma HL, Amara RR, et al. Gpl20-alum boosting of a Gag-Pol-Env DNA/MVA AIDS vaccine: poorer control of a pathogenic viral challenge. AIDS Res Hum Retroviruses. 2003;19:891-900.
35. Staprans SI, Barry AP, Silvestri G, et al. Enhanced SIV replication and accelerated progression to AIDS in macaques primed to mount a CD4 T cell response to the SIV envelope protein. Proc Natl Acad Sci USA. 2004;101:13026-13031.
36. Gilbert PB, Ackers ML, Berman PW, et al. HIV-1 virologic and immunologic progression and initiation of antiretroviral therapy among HIV-1 infected subjects in a trial of the efficacy of recombinant glycoprotein 120 vaccine. J Infect Dis. 2005;192:974-983.
37. Gilbert P, Self S, Rao M, et al. Sieve analysis: methods for assessing from vaccine trial data how vaccine efficacy varies with genotypic and phenotypic pathogen variation. J Clin Epidemiol. 2001;54:68-85.
38. Mani I, Gilbert P, Sankale JL, et al. Intrapatient diversity and its correlation with viral setpoint in human immunodeficiency virus type 1 CRF02-A/G-IbNG infection. J Virol. 2002;76:10745-10755.
39. Statement from the WHO-UNAIDS HIV vaccine advisory committee (VAC) on NIH/HVTN/MERCK release of new data from the analysis of STEP trial results. Available at: http://data.unaids.org/pub/PressStatement/2007/20071112-who- unaids-step-trial-en.pdf. Accessed December 07, 2007.
40. Buchbinder R, Osborne RH, Ebeling PR, et al. Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet. 2008;372:1881-1893.