Abdool Karim, Salim Safurdeen.Richardson, Barbra Ann.Ramjee, Gita.Hoffman, Irving F.Chirenje, Zvavahera Mike.Taha, Taha E.Kapina, Muzala.Maslankowski, Lisa.Coletti, Anne S.Profy, Albert.Moench, Thomas R.Piwowar-Manning, Estelle.Masse, Benoit.Hillier, Sharon Louise.Soto-Torres, Lydia.2012-11-152012-11-1520102010Abdool Karim, S.S. et al. 2011. Safety and effectiveness of vaginal microbicides BufferGel and 0.5% PRO 2000/5 gel for the prevention of HIV infection in women. Aids 25(7), pp. 957-966.0269-9370http://dx.doi.org/10.1097/QAD.0b013e32834541d9http://hdl.handle.net/10413/7854Results of the HPTN 035 trial. Abstract 48LB (16th Conference on Retroviruses and Opportunistic Infections, 2009).Objective: To determine the safety and effectiveness of BufferGel and 0.5% PRO2000 microbicide gels for the prevention of male-to-female HIV transmission. Design: Phase II/IIb, randomized, placebo-controlled trial with three double-blinded gel arms and an open-label no gel arm. Methods: Study participants from Malawi, South Africa, Zambia, Zimbabwe, and the USA were instructed to apply study gel up to 1 h before each sex act and safety, sexual behavior, pregnancy, gel adherence, acceptability, and HIV serostatus were assessed during follow-up. Results: The 3101 enrolled women were followed for an average of 20.4 months with 93.6% retention and 81.1% self-reported gel adherence. Adverse event rates were similar in all study arms. HIV incidence rates in the 0.5% PRO2000 gel, BufferGel, placebo gel, and no gel arms were 2.70, 4.14, 3.91, and 4.02 per 100 women-years, respectively. HIV incidence in the 0.5% PRO2000 gel arm was lower than the placebo gel arm (hazard ratio = 0.7, P=0.10) and the no gel arm (hazard ratio = 0.67, P=0.06). HIV incidence rates were similar in the BufferGel and both placebo gel (hazard ratio =1.10, P=0.63) and no gel control arms (hazard ratio =1.05, P=0.78). HIV incidence was similar in the placebo gel and no gel arms (hazard ratio =0.97, P=0.89). Conclusion: The 0.5% PRO2000 gel demonstrated a modest 30% reduction in HIV acquisition in women. However, these results were not statistically significant and subsequent findings from the Microbicide Development Programme (MDP) 301 trial have confirmed that 0.5% PRO2000 gel has little or no protective effect. BufferGel did not alter the risk of HIV infection. Both products were well tolerated.Clinical trials.HIV infections--Prevention.HIV infections--Transmission.BufferGel.Microbicide.PRO 2000 gel.Peer reviewed journal article