drugset / Trial / NCT01214759
Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)
Phase 4
Completed
103 enrolled
The University of Texas Health Science Center, Houston
Gilead Sciences · collabMerck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelPrevention
Summary
This study will evaluate the safety and tolerability of the combination of truvada and raltegravir given for 28 days for the prevention of HIV infection.
Timeline
- Start
- 2011-05
- Primary completion
- 2013-12
- Completion
- 2015-08
Publications
- Background Smith DK, Grohskopf LA, Black RJ, Auerbach JD, Veronese F, Struble KA, Cheever L, Johnson M, Paxton LA, Onorato IM, Greenberg AE; U.S. Department of Health and Human Services. Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services. MMWR Recomm Rep. 2005 Jan 21;54(RR-2):1-20.
- Background Pinkerton SD, Martin JN, Roland ME, Katz MH, Coates TJ, Kahn JO. Cost-effectiveness of HIV postexposure prophylaxis following sexual or injection drug exposure in 96 metropolitan areas in the United States. AIDS. 2004 Oct 21;18(15):2065-73. doi: 10.1097/00002030-200410210-00011.
- Background Kahn JO, Martin JN, Roland ME, Bamberger JD, Chesney M, Chambers D, Franses K, Coates TJ, Katz MH. Feasibility of postexposure prophylaxis (PEP) against human immunodeficiency virus infection after sexual or injection drug use exposure: the San Francisco PEP Study. J Infect Dis. 2001 Mar 1;183(5):707-14. doi: 10.1086/318829. Epub 2001 Feb 1.
- Background Tsai CC, Follis KE, Sabo A, Beck TW, Grant RF, Bischofberger N, Benveniste RE, Black R. Prevention of SIV infection in macaques by (R)-9-(2-phosphonylmethoxypropyl)adenine. Science. 1995 Nov 17;270(5239):1197-9. doi: 10.1126/science.270.5239.1197.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Raltegravir | Other / unclassified | 400 mg | — |
| Subject | Tenofovir | Small molecule | 200 mg | — |
| Subject | emtricitabine | Other / unclassified | 300 mg | — |