drugset / Trial / NCT00120770
Cellulose Sulfate (CS) Gel and HIV in Nigeria
Phase 3
Terminated
2160 enrolled
FHI 360
Lagos State University · collabUniversity of Port Harcourt Teaching Hospital · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.
Timeline
- Start
- 2004-11
- Primary completion
- —
- Completion
- 2007-03
Outcome
Missed primary endpoint
Stopped: “The study was halted in January 2007 due to safety concerns.”
paper a difference that was nonetheless not statistically significant (HR = 0.8, 95% CI 0.3-1.8; p = 0.56). PMID 19023429 ↗
paper we found insufficient evidence that it prevented male-to-female vaginal transmission of HIV, gonorrhea or chlamydial infection. PMID 19023429 ↗
Publications
- Halpern V, Obunge O, Ogunsola F, Otusanya S, Umo-Otong J, Wang CH, Mehta N. Interim data monitoring to enroll higher-risk participants in HIV prevention trials. BMC Med Res Methodol. 2009 Jun 23;9:44. doi: 10.1186/1471-2288-9-44.
- Halpern V, Ogunsola F, Obunge O, Wang CH, Onyejepu N, Oduyebo O, Taylor D, McNeil L, Mehta N, Umo-Otong J, Otusanya S, Crucitti T, Abdellati S. Effectiveness of cellulose sulfate vaginal gel for the prevention of HIV infection: results of a Phase III trial in Nigeria. PLoS One. 2008;3(11):e3784. doi: 10.1371/journal.pone.0003784. Epub 2008 Nov 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cellulose Sulfate | Unknown | 6 % | Other |