Phase I/II trial of the anti-HIV activity of mifepristone in HIV-infected subjects ACTG 5200

Journal of Acquired Immune Deficiency Syndromes

Volumn 53, Issue 4, 2010, Pages 491-495

  Para, Michael F ^a   Schouten, Jeff ^b   Rosenkranz, Susan L ^c   Yu, Song ^c   Weiner, David ^d   Tebas, Pablo ^d   White, C Jo ^e   Reeds, Dominic ^f   Lertora, Juan ^g   Patterson, Kristine B ^h   Daar, Eric S ⁱ   Cavert, Winston ^j   Brizz, Barbara ^k  

^a OHIO STATE UNIVERSITY   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d UNIVERSITY OF PENNSYLVANIA   (United States)

^e VGX Pharmaceuticals Inc   (United States)

^f WASHINGTON UNIVERSITY   (United States)

^g TULANE UNIVERSITY   (United States)

^h UNIVERSITY OF NORTH CAROLINA   (United States)

ⁱ HARBOR UCLA MEDICAL CENTER   (United States)

^j UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^k SOCIAL AND SCIENTIFIC SYSTEMS INC   (United States)

more..

Author keywords

Antiretroviral; Clinical trial; Mifepristone

Indexed keywords

GLUCOSE; HYDROCORTISONE; LIPID; MIFEPRISTONE; VIRUS RNA;

ADRENAL DISEASE; ADULT; ANTIVIRAL ACTIVITY; ANTIVIRAL THERAPY; ARTICLE; CD4 LYMPHOCYTE COUNT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GLUCOSE BLOOD LEVEL; HOMEOSTASIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; HYDROCORTISONE BLOOD LEVEL; LIPID BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH;

ADULT; ANTI-HIV AGENTS; CD4 LYMPHOCYTE COUNT; DOUBLE-BLIND METHOD; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; MIDDLE AGED; MIFEPRISTONE; PLACEBOS; RNA, VIRAL; TREATMENT OUTCOME; VIRAL LOAD; YOUNG ADULT;

EID: 77949398789     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/QAI.0b013e3181d142cb     Document Type: Article

References (17)

1. Levy J. Pathogenesis of human immunodeficiency virus infection. Microbial Rev. 1993;57:183-289.
2. Connor RI, Chen BK, Choe S, et al. Vpr is required for efficient replication of human immunodeficiency virus type-1 in mononuclear phagocytes. Virology. 1995;206:935.
3. Refaeli Y, Levy DN, Weiner DB. The glucocorticoid receptor type II complex is a target of the HIV-1 vpr gene product. Proc Natl Acad Sci USA. 1995;92:3621.
4. Ayyavoo V, Mahboubi A, Mahalingam S, et al. HIV-1 Vpr suppresses immune activation and apoptosis through regulation of nuclear factor kappa B. Nat Med. 1997;3:1117-1123.
5. Ramanathan MP, Curley E, Su M, et al. Carboxyl terminus of hVIP/ mov34 is critical for HIV-1-Vpr interaction and glucocorticoid-mediated signaling. J Biol Chem. 2002;277:47854-47860.
6. Kino T, Gragerov A, Kopp JB, et al. The HIV-1 virion-associated protein vpr is a coactivator of the human glucocorticoid receptor. J Exp Med. 1999;189:51-62.
7. Muthumari K, Boyer J, Choo A, et al. Therapeutic inhibition of SIV replication in macaques by GR blockade and implications for therapy of HIV-1. Presented at: 12th CROI; February 22-25, 2005; Boston, MA. Abstract 158.
8. Heikinheimo O, Kekkonen R. Dose response relationship of RU486. Ann Med. 1993;25:71-76.
9. Foldesi I, Falkay G, Kovacs L. Determination of RU486 (mifepristone) in blood by radioreceptor assay: a pharmacokinetic study. Contraception. 1996;54:27-32.
10. Kekkonen R, Heikinheimo O, Mandelin E, et al. Pharmacokinetics of mifepristone after low oral doses. Contraception. 1996;54: 229-234.
11. Sarkar N. Mifepristone: bioavailability, pharmacokinetics and use-effectiveness. Euro J Obst Gynecol Repro Bio. 2002;101:113-120.
12. Liu IH, Carzo VO, Ven SSC. Pharmacokinetics of antiprogesterone RU486 in women after oral administration. Fertil Steril. 1988;50:245-249.
13. Sartos O, Figg W. Mifepristone: antineoplastic studies. Clin Obstet Gynecol. 1996;39:498-505.
14. Heikinheimo O. Clinical pharmacokinetics of mifepristone. Clin Pharmacokinet. 1997;33:7-17.
15. Yong-en S, Zhi-hou Y, Chang-hai H. et al. Pharmacokinetic study of RU486 and its metabolites after oral administration of single doses to pregnant and non-pregnant women. Contraception. 1993;48:133-149.
16. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Developed by the Panel on Clinical Practices for Treatment of HIV Infection convened by the Department of Health and Human Services. March 23, 2004;1-97. Available at http:// www.aidsinfo.nih.gov/ContentFiles/ AdultandAdolescentGL.pdf. Accessed February 1, 2010.
17. Regulatory Compliance Center. Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences. Bethesda, MD: NAIDD; August 1992. Available at: http://rcc.tech-res.com/tox-tables.htm.