drugset / Trial / NCT01340950
Clinical Trial of Brain-Penetrating HIV Drugs to Prevent Cognitive Impairment in China
Phase 4
Completed
250 enrolled
University of California, San Diego
Beijing Ditan Hospital · collabBeijing YouAn Hospital · collabNational Center for AIDS/STD Control and Prevention, China CDC · collabNational Institute of Mental Health (NIMH) · collabPeking University · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This primary aim of the project is to determine the association between antiretroviral therapy that better distributes into the central nervous system and prevention of HIV-associated neurocognitive impairment.
Timeline
- Start
- 2010-07
- Primary completion
- 2014-07
- Completion
- 2015-07
Publications
- Background Heaton RK, Cysique LA, Jin H, Shi C, Yu X, Letendre S, Franklin DR, Ake C, Vigil O, Atkinson JH, Marcotte TD, Grant I, Wu Z; San Diego HIV Neurobehavioral Research Center Group. Neurobehavioral effects of human immunodeficiency virus infection among former plasma donors in rural China. J Neurovirol. 2008 Nov;14(6):536-49. doi: 10.1080/13550280802378880.
- Background Cysique LA, Letendre SL, Ake C, Jin H, Franklin DR, Gupta S, Shi C, Yu X, Wu Z, Abramson IS, Grant I, Heaton RK; HIV Neurobehavioral Research Center group. Incidence and nature of cognitive decline over 1 year among HIV-infected former plasma donors in China. AIDS. 2010 Apr 24;24(7):983-90. doi: 10.1097/QAD.0b013e32833336c8.
- Background Spector SA, Singh KK, Gupta S, Cystique LA, Jin H, Letendre S, Schrier R, Wu Z, Hong KX, Yu X, Shi C, Heaton RK; HNRC Group. APOE epsilon4 and MBL-2 O/O genotypes are associated with neurocognitive impairment in HIV-infected plasma donors. AIDS. 2010 Jun 19;24(10):1471-9. doi: 10.1097/QAD.0b013e328339e25c.
- Background Letendre S, Marquie-Beck J, Capparelli E, Best B, Clifford D, Collier AC, Gelman BB, McArthur JC, McCutchan JA, Morgello S, Simpson D, Grant I, Ellis RJ; CHARTER Group. Validation of the CNS Penetration-Effectiveness rank for quantifying antiretroviral penetration into the central nervous system. Arch Neurol. 2008 Jan;65(1):65-70. doi: 10.1001/archneurol.2007.31.
- Background Letendre SL, McCutchan JA, Childers ME, Woods SP, Lazzaretto D, Heaton RK, Grant I, Ellis RJ; HNRC Group. Enhancing antiretroviral therapy for human immunodeficiency virus cognitive disorders. Ann Neurol. 2004 Sep;56(3):416-23. doi: 10.1002/ana.20198.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Efavirenz | Other / unclassified | 600 mg | Oral |
| Comparator | Nevirapine | Small molecule | 200 mg | Oral |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Comparator | Zidovudine | Small molecule | 300 mg | Oral |
| Comparator | Lamivudine | Other / unclassified | 300 mg | Oral |