Pharmacokinetics and placental transfer of single-dose tenofovir 1% vaginal gel in term pregnancy

Journal of Infectious Diseases

Volumn 204, Issue 10, 2011, Pages 1527-1531

  Beigi, Richard ^a,b   Noguchi, Lisa ^b,d   Parsons, Teresa ^c   Macio, Ingrid ^a   Kunjara Na Ayudhya, Ratiya P ^b   Chen, Jianmeng ^c   Hendrix, Craig W ^c   Mâsse, Benoît ^g,i   Valentine, Megan ^h   Piper, Jeanna ^e   Watts, D Heather ^f  

^a UNIVERSITY OF PITTSBURGH   (United States)

^b UNIVERSITY OF PITTSBURGH   (United States)

^c JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d JOHNS HOPKINS UNIVERSITY   (United States)

^e NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^f EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^g Fred Hutchinson Cancer Research Center   (United States)

^h FAMILY HEALTH INTERNATIONAL   (United States)

ⁱ UNIVERSITÉ DE MONTRÉAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

TENOFOVIR;

ABSENCE OF SIDE EFFECTS; ADULT; AMNION FLUID; CESAREAN SECTION; CONFERENCE PAPER; CONTROLLED STUDY; DISEASE TRANSMISSION; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG FORMULATION; DRUG SAFETY; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MATERNAL BLOOD; MAXIMUM PLASMA CONCENTRATION; PHASE 1 CLINICAL TRIAL; PLACENTAL TRANSFER; PREGNANCY; PREOPERATIVE CARE; PRIORITY JOURNAL; SEXUAL TRANSMISSION; SINGLE DRUG DOSE; TANDEM MASS SPECTROMETRY; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY; UMBILICAL CORD BLOOD;

ADENINE; ADULT; AMNIOTIC FLUID; ANTI-HIV AGENTS; CESAREAN SECTION; ENDOMETRIUM; FEMALE; FETAL BLOOD; HUMANS; MATERNAL-FETAL EXCHANGE; PHOSPHONIC ACIDS; PLACENTA; PREGNANCY; VAGINAL CREAMS, FOAMS, AND JELLIES;

EID: 80054773666     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jir562     Document Type: Conference Paper

References (15)

1. World Health Organization. 2009 AIDS epidemic update. http:// data.unaids.org/pub/Report/2009/JC1700-Epi-Update-2009-en.pdf. Accessed 1 November 2010.
2. Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science 2010; 5996:1168-74.
3. Raymond EG, Taylor D, Cates W Jr, et al. Pregnancy in effectiveness trials of HIV prevention agents. Sex Transms Dis 2007; 34:1035-9. (Pubitemid 350158859)
4. Lagakos S, Gabel A. Methodological challenges in biomedical HIV prevention trials. Washington, DC: The National Academies Press, 2008.
5. Gray RH, Li X, Kigozi G, et al. Increased risk of incident HIV during pregnancy in Rakai, Uganda: A prospective study. Lancet 2005; 366: 1182-8. (Pubitemid 41393596)
6. Birkhead GS, Pulver WP, Warren BL, et al. Acquiring human immunodeficiency virus during pregnancy and mother-to-child transmission in New York. Obstet Gynecol 2010; 115:1247-55.
7. Solberg DA, Butler J, Wagner NN. Sexual behavior in pregnancy. N Engl J Med 1973; 288:1098-103.
8. King T, Bushman L, Anderson PL, Delahunty T, Ray M, Fletcher CV. Quantitation of zidovudine triphosphate concentrations from human peripheral blood mononuclear cells by anion exchange solid phase extraction and liquid chromatography-tandem mass spectroscopy; an indirect quantitation methodology. J Chromatogr B Analyt Technol Biomed Life Sci 2006; 831:248-57. (Pubitemid 43155802)
9. Keller MJ, Madan RP, Torres NM, et al. Development of biomarkers of microbicide efficacy and safety in a phase I study of tenofovir vaginal gel. Plos One. In press.
10. Mirochnick M, Kafulafula G, Kreitchmann R, et al. Pharmacokinetics (PK) of tenofovir disoproxil fumarate (TDF) after administration to HIV-1 infected pregnant women and their newborns [abstract #T-137]. In: Program and abstracts from the 16th Conference on Retroviruses and Opportunistic Infections (Montreal, Canada) Alexandria, VA: CROI 2009.
11. Barditch-Crovo P, Deeks SG, Collier A, et al. Phase I/II trial of the pharmacokinetics, safety, and antiretroviral activity of tenofovir disoproxil fumarate in human immunodeficiency virus-infected adults. Antimicrob Agents Chemother 2001; 45:2733-9. (Pubitemid 32906664)
12. Tarantal AF, Marthas ML, Shaw JP, et al. Administration of 9-[2-(R)-(phophonomethoxy)propyl]adenine (PMPA) to gravid and infant rhesus macaques (Macacca mulatta): safety and efficacy studies. J Acquir Immune Defic Syndr Hum Retrovirol 1999; 20:323-33. (Pubitemid 29143025)
13. Mayer KH, Maslankowski LA, Gai F, et al. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS 2006; 20:543-51. (Pubitemid 43731598)
14. United States Food and Drug Administration. FDA pregnancy categories. http://depts.washington.edu/druginfo/Formulary/Pregnancy.pdf. Accessed 15 October 2010.
15. The Antiretroviral Pregnancy Registry. Semiannual report through 7-31-2010. http://www.apregistry.com/index.htm. Accessed 1 April 2011.