Administration of 9-[2-(R)-(phosphonomethoxy)propyl]adenine (PMPA) to gravid and infant rhesus macaques (Macaca mulatta): Safety and efficacy studies

Journal of Acquired Immune Deficiency Syndromes and Human Retrovirology

Volumn 20, Issue 4, 1999, Pages 323-333

  Tarantal, Alice F ^a,b,d   Marthas, Marta L ^a   Shaw, Jing Ping ^c   Cundy, Ken ^c   Bischofberger, Norbert ^c  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c GILEAD SCIENCES   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Bone toxicity; Fetus; Monkey; Placental transport; PMPA; Pregnancy; SIV

Indexed keywords

TENOFOVIR;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CESAREAN SECTION; CLINICAL CHEMISTRY; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FETUS WEIGHT; IMMUNOPHENOTYPING; INTRAVENOUS DRUG ADMINISTRATION; MACACA; NEWBORN; NONHUMAN; ORAL DRUG ADMINISTRATION; PLACENTAL TRANSFER; PREGNANCY; PRIORITY JOURNAL; REVERSE TRANSCRIPTION; SIMIAN IMMUNODEFICIENCY VIRUS; SUBCUTANEOUS DRUG ADMINISTRATION; VIRUS LOAD;

EID: 0033040847     PISSN: 10779450     EISSN: None     Source Type: Journal    
DOI: 10.1097/00042560-199904010-00001     Document Type: Article

References (28)

1. Domachowske JB. Pediatric human immunodeficiency virus infection. Clin Microb Rev 1996;9:448-68.
2. Blanche S, Mayaux M-J, Rouzioux BA, et al. Relation of the course of HIV infection in children to the severity of the disease in their mothers at delivery. N Engl J Med 1994;30:308-12.
3. Wilfert CM, Wilson C, Luzuriaga K, Epstein L. Pathogenesis of pediatric human immunodeficiency virus type 1 infection. J Infect Dis 1994;170:286-92.
4. Dickover RE, Dillon M, Gillette SG et al. Rapid increases in load of human immunodeficiency virus correlate with early disease progression and loss of CD4 cells in vertically infected infants. J Infect Dis 1994;170:1279-84.
5. Lamers SL, Sleasman JW, She JX, et al. Persistence of multiple maternal genotypes of human immunodeficiency virus type 1 in infants infected by vertical transmission. J Clin Invest 1994;93: 380-90.
6. + T-cell repertoire that are not immediately restored by antiviral or immune-based therapies. Nat Med 1997;3:533-40.
7. Melvin AJ, Mohan KM, Manns Arcuino LA, Edelstein RE, Frenkel LM. Clinical, virologie and immunologic responses of children with advanced human immunodeficiency virus type 1 disease treated with protease inhibitors. Pediatr Infect Dis J 1997;16:968-74.
8. Rutstein RM, Feingold A, Meislich D, Word B, Rudy B. Protease inhibitor therapy in children with perinatally acquired HIV infection. AIDS 1997;11:F107-11.
9. Robbins BL, Fiedland A. Metabolism and therapeutic activity of acyclic adenine phosphonate analogues, Int Antiviral News 1996; 4:57-8.
10. Tsai C-C, Follis KE, Beck TW, et al. Prevention of simian immunodeficiency virus infection in macaques by 9-(2-phosphonylmethoxypropyl)adenine (PMPA). Science 1995;270:1197-9.
11. Van Rompay KKA, Cherrington JM, Marthas ML, et al. 9-(Phosphonomethoxy)propyl]adenine therapy of established simian immunodeficiency virus infection in infant rhesus macaques. Antimicrob Agents Chemother 1996;40:2586-91.
12. Decks SG, Barditch-Crovo P, Lietman PS, et al. Safety, pharmacokinetics, and antiretroviral activity of intravenous 9-[2-(R)-(Phosphonomethoxy)propyl]adenine, a novel anti-human immunodeficiency virus (HIV) therapy, in HIV-infected adults. Antimicrob Agents Chermother 1998;42:2380-4.
13. Tarantal AF, Hendrickx AG. Prenatal growth in the cynomolgus and rhesus macaque (Macaca fascicularis and Macaca mulatta): a comparison by ultrasonography. Am J Primatol 1988; 15:309-23.
14. Tarantal AF, Gargosky SE. Characterization of the insulin-like growth factor axis in the serum of maternal and fetal macaques (Macaca mulatta and Macaca fascicularis). Growth Regul 1995; 5:190-8.
15. Tarantal AF. Interventional ultrasound in pregnant macaques: embryonic/fetal applications. J Med Primatol 1990;19:47-58.
16. Tarantal AF, Marthas ML, McChesney MB, et al. Effects of SIV infection on fetal development and pregnancy outcome in the rhesus macaque (Macaca mulatta). Pediatr AIDS HIV Infect: Fetus Adolesc 1993;4:373-80.
17. Tarantal AF, Marthas ML, Gargosky SE, et al. Effects of viral virulence on intrauterine growth in SIV-infected fetal rhesus macaques. J Acquir Immune Defic Syndr Hum Retrovirol 1995;10: 129-38.
18. Cundy KC, Shaw J-P, Lee WA. Oral bioavailability of the anti-retroviral agent 9-(2-phosphonylmethoxyethyl)adenine (PMEA) from three formulations of the prodrug bis(pivaloyloxymethyl)-PMEA in fasted male cynomolgous monkeys. Pharmacol Res 1994;11:839-43.
19. Tarantal AF. Hematologic reference values for the fetal long-tailed macaque (Macaca fascicularis). Am J Primatol 1993;29:209-19.
20. Tarantal AF, Hendrickx AG. Evaluation of the bioeffects of prenatal ultrasound exposure in the cynomolgus macaque (Macaca fascicularis): I. neonatal/infant observations. Teratology 1989;39: 137-47.
21. Tsai C-C, Follis KE, Beck TW, Sabo A, Bischofberger N, Dailey PJ. Effects of (R)-9-(2-Phosphonylmethoxypropyl)adenine monotherapy on chronic SIV infection in macaques. AIDS Res Hum Retroviruses 1997;13:707-12.
22. Balzarini J, Aquaro S, Perno C-F, Witvrouw M, Holy A, De Clercq E. Activity of the (R)-Enantiomers of 9-(2-Phosphonylmethoxypropyl)-Adenine and 9-(2-Phosphonylmethoxypropyl)-2,6-diaminopurine against human immunodeficiency virus in different human cell systems. Biochem Biophys Res Commun 1996;219: 337-41.
23. Barditch-Crovo P, Toole J, Hendrix CW, et al. Anti-human immunodeficiency virus (HIV) activity, safety, and pharmacokinetics of adefovir dipivoxil (9-[2-(bis-pivaloyloxymethyl)-phosphonylmethoxyethyl]adenine) in HIV-infected patients. J Infect Dis 1997; 176:406-13.
24. Van Rompay KKA, Marthas ML, Lifson JD, et al. Administration of 9-[2-(Phosphonomethoxy)-propyl]adenine (PMPA) for prevention of perinatal simian immunodeficiency virus infection in rhesus macaques. AIDS Res Human Retroviruses 1998;14:761-73.
25. Van Rompay KKA, Berardi CJ, Aguirre NL, et al. Two doses of 9-[2-(Phosphonomethoxy)-propyl]adenine (PMPA) protect newborn macaques against oral simian immunodeficiency virus infection. AIDS 1998;12:F79-83.
26. Centers for Disease Control and Prevention. Recommendations of the U.S. Public Health Service Task Force on the use of zidovudine to reduce perinatal transmission of human immunodeficiency virus. MMWR Morb Mortal Wkly Rep 1994;(No. RR-11):43.
27. 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;22:1621-9.
28. Tarantal AF, Spanggord RJ, Hendrickx AG. Pre- and postnatal treatment of the rhesus macaque (Macaca mulatta) with azidothymidine (AZT). I. Fetal studies. Pediatr AIDS HIV Infect: Fetus Adolesc 1994;5:10-19.