drugset / Trial / NCT00442910
Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women
Phase 1
Completed
61 enrolled
Starpharma Pty Ltd
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabMicrobicide Trials Network · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
There is an urgent need for HIV prevention methods that women can initiate and control themselves. Topical microbicides, substances that kill microbes, represent one such method. The purpose of this study is to assess the safety and to evaluate the acceptability of 3% w/w SPL7013 gel, a topical microbicide, when administered intravaginally for 14 consecutive days in healthy, sexually active HIV uninfected women.
Timeline
- Start
- 2007-07
- Primary completion
- 2009-12
- Completion
- 2009-12
Publications
- Background Balzarini J, Van Damme L. Microbicide drug candidates to prevent HIV infection. Lancet. 2007 Mar 3;369(9563):787-797. doi: 10.1016/S0140-6736(07)60202-5.
- Background Rupp R, Rosenthal SL, Stanberry LR. VivaGel (SPL7013 Gel): a candidate dendrimer--microbicide for the prevention of HIV and HSV infection. Int J Nanomedicine. 2007;2(4):561-6.
- McGowan I, Gomez K, Bruder K, Febo I, Chen BA, Richardson BA, Husnik M, Livant E, Price C, Jacobson C; MTN-004 Protocol Team. Phase 1 randomized trial of the vaginal safety and acceptability of SPL7013 gel (VivaGel) in sexually active young women (MTN-004). AIDS. 2011 May 15;25(8):1057-64. doi: 10.1097/QAD.0b013e328346bd3e.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | SPL7013 | Other / unclassified | 3.5 g | Other |
Indications
No indication recorded.