NCT00270257 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Aceijas C, Stimson GV, Hickman M, Rhodes T; United Nations Reference Group on HIV/AIDS Prevention and Care among IDU in Developing and Transitional Countries
Global overview of injecting drug use and HIV infection among injecting drug users. AIDS. 2004 Nov 19;18(17):2295-303.
Gowing L, Farrell M, Bornemann R, Ali R
Substitution treatment of injecting opioid users for prevention of HIV infection. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD004145. Review. Update in: Cochrane Database Syst Rev. 2008;(2):CD004145.
Koester S, Glanz J, Barón A
Drug sharing among heroin networks: implications for HIV and hepatitis B and C prevention. AIDS Behav. 2005 Mar;9(1):27-39.
Raisch DW, Fye CL, Boardman KD, Sather MR
Opioid dependence treatment, including buprenorphine/naloxone. Ann Pharmacother. 2002 Feb;36(2):312-21. Review.
Ruan Y, Qin G, Liu S, Qian H, Zhang L, Zhou F, He Y, Chen K, Yin L, Chen X, Hao Q, Xing H, Song Y, Wang Y, Hong K, Chen J, Shao Y
HIV incidence and factors contributed to retention in a 12-month follow-up study of injection drug users in Sichuan Province, China. J Acquir Immune Defic Syndr. 2005 Aug 1;39(4):459-63.

A Phase III Randomized Controlled Trial to Evaluate the Efficacy of Drug Treatment in Prevention of HIV Infection and Death Among Opiate Dependent Injectors

Details for clinical trial NCT00270257

Clinical trial NCT00270257 - References