PRO-2000

Present inquisition was undertaken to evaluate the genotoxicity of naphthalene-2-sulfonate (2NS), a sulfonated aromatic compound and a momentous intermediate involved in the synthesis of dyes and surfactants, in fresh water fish, Channa punctatus. After LC₅₀ determination, two sublethal concentrations i.e. 2.38 g/15 g b.w. (1/4 of LC₅₀) and 4.77 g/15 g b.w. (1/2 of LC₅₀) were selected for studying acute exposure. For evaluating sub chronic exposure 1/10th (0.238 g/L) and 1/20th (0.119 g/L) of safe application rate (SAR) were reckoned. Blood samples were collected after 24, 48, 72, and 96 h exposure period to study acute effect, and after 30 and 60 days exposure period for sub-chronic effect. Symbolic elevation in time and dose dependent DNA damage was observed by comet assay as well as micronucleus test revealing maximum damage after 60 days of exposure. After cessation of exposure to 2NS, evident recovery was observed after 30 days. Along with comet assay and micronucleus test, spectroscopic evaluation of DNA damage was also noted using Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR). The biomolecular range (800 cm^-1 - 1800cm-¹) in lyophilized red blood cell's extracted from 60 days exposed as well as control group exhibit significant alterations in their nucleic acid indicated through multivariate analysis i.e. Principal Component Analysis (PCA). Further structural analysis of erythrocytes in maximally damaged group using Scanning Electron Microscopy was performed. Thus the study proposed the genotoxic impact of 2NS which is further supported by other toxicity markers like ATR-FTIR and Scanning Electron Microscopy.

To estimate the effectiveness of candidate microbicides BufferGel and 0.5% PRO 2000 Gel (P) (PRO 2000) for prevention of non-ulcerative sexually transmitted infections (STIs).

Between 2005 and 2007, 3099 women were enrolled in HIV Prevention Trials Network (HPTN) protocol 035, a phase II/IIb evaluation of the safety and effectiveness of BufferGel and PRO 2000 for prevention of STIs, including Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV). Incidences of STIs were determined by study arm, and HRs of BufferGel and PRO 2000 versus placebo gel or no gel control groups were computed using discrete time Andersen-Gill proportional hazards model.

The overall incidence rates were 1.6/100 person-years at risk (PYAR) for NG, 3.9/100 PYAR for CT and 15.3/100 PYAR for TV. For BufferGel versus placebo gel, HRs were 0.99 (95% CI 0.49 to 2.00), 1.00 (95% CI 0.64 to 1.57) and 0.95 (95% CI 0.71 to 1.25) for prevention of NG, CT and TV, respectively. For PRO 2000, HRs were 1.66 (95% CI 0.90 to 3.06), 1.16 (95% CI 0.76 to 1.79) and 1.18 (95% CI 0.90 to 1.53) for prevention of NG, CT and TV, respectively.

The incidence of STIs was high during HIV Prevention Trials Network 035 despite provision of free condoms and comprehensive risk-reduction counselling, highlighting the need for effective STI prevention programmes in this population. Unfortunately, candidate microbicides BufferGel and PRO2000 had no protective effect against gonorrhoea, chlamydia or trichomoniasis.

NCT00074425.