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Phase III trial of 6% cellulose sulfate (CS) gel for the prevention of HIV transmission
Presented by Lut Van Damme, United States.
Van Damme L.1, Govinden R.2, Mirembe F.3, Guedou F.4, Solomon S.5, Becker M.L.6, Pradeep B.7, Alary M.4, Nakabiito C.8, Ramjee G.2, Murphy S.1, Deese J.9, Crucitti T.10, Taylor D.9
1CONRAD, Arlington, VA, United States, 2Medical Research Council, HIV Prevention Research Unit, Durban, South Africa, 3Makarere University, Kampala, Uganda, 4Centre hospitalier affilie universitaire de Quebec, Quebec, Canada, 5YRG Care, Chennai, India, 6University of Manitoba, Department of Medical Microbiology, Winnipeg, Canada, 7St John's Medical College, Institute of Population Health and Clinical Research, Bangalore, India, 8Mulago Hospital, Kampala, Uganda, 9Family Health International, Research Triangle Park, NC, United States, 10Institute of Tropical Medicine, Microbiology, Antwerp, Belgium
Objectives: Assess the effectiveness of 6% CS gel in preventing the male-to-female vaginal transmission of HIV and gonococcal and chlamydial infection
Methods:
- Randomized, blinded, placebo-controlled two-arms
- Multi-partner women at high risk of HIV infection in three African and two Indian sites
- Planned sample size: 2574 HIV negative women
- Each participant was asked to apply her assigned gel in her vagina within one hour before each intercourse for 12 months
- The main analysis was done under the intent-to-treat principle
- An interim analysis was presented to the study’s Independent Data Monitoring Committee (IDMC) on 26 January 2007 (as per protocol)
Results: Enrollment started on 20 July 2005. The study was prematurely stopped on 29 January 2007, based on the IDMC’s recommendation. The last participant study visit was 31 March 2007.
A total of 2963 women have been screened of whom 1429 were enrolled; 88% completed the study, 2% were discontinued early , and 10% were lost-to-follow-up; 1396 were included in the primary analysis for HIV. The full analysis is ongoing; final results (table below) will be presented at the conference.
| Endpoints | Treatment group | RR (95%CI) | p-value | | HIV | CS | Placebo | | | | At interim analysis | | | | | | Final result | | | | | | N. gonorrhoeae | | | | | | C. trachomatis | | | | |
Conclusions: CS shows no potential to prevent HIV transmission. CONRAD will conduct further pre-clinical and clinical research to try to identify causal factors for the unexpected negative effect on HIV observed in the interim analysis. The identification of biological markers for safety/efficacy are urgently needed to help determine the suitability of products to move further in advanced clinical testing.
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