Durable protection from vaginal simian-human immunodeficiency virus infection in macaques by tenofovir gel and its relationship to drug levels in tissue

Journal of Virology

Volumn 86, Issue 2, 2012, Pages 718-725

  Dobard, Charles ^a   Sharma, Sunita ^a   Martin, Amy ^a   Pau, Chou Pong ^a   Holder, Angela ^a   Kuklenyik, Zsuzsanna ^a   Lipscomb, Jonathan ^a   Hanson, Debra L ^a   Smith, James ^a   Novembre, Francis J ^b   García Lerma, J Gerardo ^a   Heneine, Walid ^a  

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

^b EMORY UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; PLACEBO; TENOFOVIR; TENOFOVIR DIHOSPHATE; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ANTIVIRAL ACTIVITY; ANTIVIRAL RESISTANCE; ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CONCENTRATION; DRUG EFFICACY; DRUG HALF LIFE; DRUG TISSUE LEVEL; FEMALE; IC 95; IN VITRO STUDY; LENTIVIRUS INFECTION; LYMPHOCYTE; MACACA; NONHUMAN; PERIPHERAL BLOOD MONONUCLEAR CELL; PRIORITY JOURNAL; SIMIAN HUMAN IMMUNODEFICIENCY VIRUS; SIMIAN HUMAN IMMUNODEFICIENCY VIRUS INFECTION; SIMIAN IMMUNODEFICIENCY VIRUS; SURVIVAL RATE; VAGINAL LAVAGE; VIREMIA;

ADENINE; ANIMALS; ANTI-HIV AGENTS; CELLS, CULTURED; DRUG STABILITY; FEMALE; HALF-LIFE; HIV INFECTIONS; HIV-1; HUMANS; LEUKOCYTES, MONONUCLEAR; LONGITUDINAL STUDIES; PHOSPHONIC ACIDS; SIMIAN ACQUIRED IMMUNODEFICIENCY SYNDROME; SIMIAN IMMUNODEFICIENCY VIRUS; VAGINA; VAGINAL CREAMS, FOAMS, AND JELLIES;

MACACA; SIMIAN-HUMAN IMMUNODEFICIENCY VIRUS;

EID: 84863115647     PISSN: 0022538X     EISSN: 10985514     Source Type: Journal    
DOI: 10.1128/JVI.05842-11     Document Type: Article

References (39)

1. Abdool Karim Q, et al. 2010. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 329:1168-1174.
2. Atashili J, Poole C, Ndumbe PM, Adimora AA, Smith JS. 2008. Bacterial vaginosis and HIV acquisition: a meta-analysis of published studies. AIDS 22:1493-1501.
3. Dumond JB, et al. 2007. Antiretroviral drug exposure in the female genital tract: implications for oral pre- and post-exposure prophylaxis. AIDS 21:1899-1907.
4. García-Lerma JG, et al. 2008. Prevention of rectal SHIV transmission in macaques by daily or intermittent prophylaxis with emtricitabine and tenofovir. PLoS Med. 5:e28.
5. Garcia-Lerma JG, et al. 2010. Intermittent prophylaxis with oral truvada protects macaques from rectal SHIV infection. Sci. Transl. Med. 2:14ra4.
6. Harouse JM, et al. 2001. Mucosal transmission and induction of simian AIDS by CCR5-specific simian/human immunodeficiency virus SHIV(SF162P3). J. Virol. 75:1990-1995.
7. Harouse JM, Gettie A, Tan RC, Blanchard J, Cheng-Mayer C. 1999. Distinct pathogenic sequela in rhesus macaques infected with CCR5 or CXCR4 utilizing SHIVs. Science 284:816-819.
8. Hawkins T, et al. 2005. Intracellular pharmacokinetics of tenofovir diphosphate, carbovir triphosphate, and lamivudine triphosphate in patients receiving triple-nucleoside regimens. J. Acquir. Immune Defic. Syndr. 39:406-411.
9. Johnson JA, Rompay KK, Delwart E, Heneine W. 2006. A rapid and sensitive real-time PCR assay for the K65R drug resistance mutation in SIV reverse transcriptase. AIDS Res. Hum. Retroviruses 22:912-916.
10. Klasse PJ, Shattock R, Moore JP. 2008. Antiretroviral drug-based microbicides to prevent HIV-1 sexual transmission. Annu. Rev. Med. 59: 455-471.
11. Kuklenyik Z, et al. 2009. Effect of mobile phase pH and organic content on liquid chromatography mass spectrometry analysis of nucleoside and nucleotide HIV reverse transcriptase inhibitors. J. Chromatogr. Sci. 47: 365-372.
12. Lichtenwalner AB, Patton DL, Klebanoff SJ, Headley CM, Hillier SL. 2000. Vaginal myeloperoxidase and flora in the pig-tailed macaque. J. Med. Primatol. 29:36-41.
13. Liu J, et al. 2010. Low-dose mucosal simian immunodeficiency virus infection restricts early replication kinetics and transmitted virus variants in rhesus monkeys. J. Virol. 84:10406-10412.
14. Livingston L, et al. 2011. Hormonal synchronization of the menstrual cycles of pigtail macaques to facilitate biomedical research including modeling HIV susceptibility. J. Med. Primatol. 40:164-170.
15. Longini IM, Jr, Datta S, Halloran ME. 1996. Measuring vaccine efficacy for both susceptibility to infection and reduction in infectiousness for prophylactic HIV-1 vaccines. J. Acquir. Immune Defic. Syndr. Hum. Retrovirol. 13:440-447.
16. Mayer KH, et al. 2006. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS 20:543-551.
17. Molenberghs G, Verbeke G. 1997. Linear mixed models for longitudinal data. Springer, Berlin, Germany.
18. Münch J, et al. 2007. Semen-derived amyloid fibrils drastically enhance HIV infection. Cell 131:1059-1071. 18a. National Research Council. 1996. Guide for the care and use of laboratory animals. National Academy Press, Washington, DC.
19. Oehlert GW. 1992. A note on the delta method. Am. Stat. 46:27-29.
20. Otten RA, et al. 2005. Multiple vaginal exposures to low doses of R5 simian-human immunodeficiency virus: strategy to study HIV preclinical interventions in nonhuman primates. J. Infect. Dis. 19:164-173.
21. Parikh UM, et al. 2009. Complete protection from repeated vaginal simian-human immunodeficiency virus exposures in macaques by a topical gel containing tenofovir alone or with emtricitabine. J. Virol. 83: 10358-10365.
22. Pilcher CD, et al. 2004. Brief but efficient: acute HIV infection and the sexual transmission of HIV. J. Infect. Dis. 189:1785-1792.
23. Platt EJ, Bilska M, Kozak SL, Kabat D, Montefiori DC. 2009. Evidence that ecotropic murine leukemia virus contamination in TZM-bl cells does not affect the outcome of neutralizing antibody assays with human immunodeficiency virus type 1. J. Virol. 83:8289-8292.
24. Potts M. 1994. The urgent need for a vaginal microbicide in the prevention of HIV transmission. Am. J. Public Health 84:890-891.
25. Saltzman W, Schultz-Darken NJ, Scheffler G, Wegner FH, Abbott DH. 1994. Social and reproductive influences on plasma cortisol in female marmoset monkeys. Physiol. Behav. 56:801-810.
26. Salvato MS, Rater M, Pauza CD. 1996. Tracking of dye-labeled lymphocytes in rhesus macaques. J. Med. Primatol. 25:112-121.
27. Schwartz JL, et al. 2011. A multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1% tenofovir gel. PLoS One 6:e25974.
28. Srinivas RV, Fridland A. 1998. Antiviral activities of 9-R-2-phosphonomethoxypropyl adenine (PMPA) and bis(isopropyloxymethylcarbonyl) PMPA against various drug-resistant human immunodeficiency virus strains. Antimicrob. Agents Chemother. 42:1484-1487.
29. Subbarao S, et al. 2006. Chemoprophylaxis with tenofovir disoproxil fumarate provided partial protection against infection with simian human immunodeficiency virus in macaques given multiple virus challenges. J. Infect. Dis. 194:904-911.
30. UNAIDS/WHO. 2008. Report on the global HIV/AIDS epidemic 2008. UNAIDS, Geneva, Switzerland.
31. van Rompay KK, et al. 1996. 9-[2-(Phosphonomethoxy)propyl]adenine therapy of established simian immunodeficiency virus infection in infant rhesus macaques. Antimicrob. Agents Chemother. 40: 2586-2591.
32. Veazey RS, et al. 2005. Protection of macaques from vaginal SHIV challenge by vaginally delivered inhibitors of virus-cell fusion. Nature 438: 99-102.
33. Veazey RS, et al. 2010. Protection of rhesus macaques from vaginal infection by vaginally delivered maraviroc, an inhibitor of HIV-1 entry via the CCR5 co-receptor. J. Infect. Dis. 202:739-744.
34. Vishwanathan SA, et al. 2011. High susceptibility to repeated, low-dose, vaginal SHIV exposure late in the luteal phase of the menstrual cycle of pigtail macaques. J. Acquir. Immune Defic. Syndr. 57:261-264.
35. Voelker R. 2005. Women shoulder growing HIV/AIDS burden. JAMA 293:281-282.
36. von Ehrenstein OS, et al. 2009. Polyfluoroalkyl chemicals in the serum and milk of breastfeeding women. Reprod. Toxicol. 27:239-245.
37. Weber J, Desai K, Darbyshire J. 2005. The development of vaginal microbicides for the prevention of HIV transmission. PLoS Med. 2:e142.
38. Weiler AM, et al. 2008. Genital ulcers facilitate rapid viral entry and dissemination following intravaginal inoculation with cell-associated simian immunodeficiency virus SIVmac239. J. Virol. 82:4154-4158.
39. Yeh RF, et al. 2009. Genital tract, cord blood, and amniotic fluid exposures of seven antiretroviral drugs during and after pregnancy in human immunodeficiency virus type 1-infected women. Antimicrob. Agents Chemother. 53:2367-2374.