Browsing by Author "Masse, Benoit."

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Challenges in HIV-prevention microbicide research.
(American Association for the Advancement of Science., 2008) Harrison, Polly.; Mellors, John W.; Richardson, Barbra Ann.; Masse, Benoit.; Abdool Karim, Quarraisha.; Abdool Karim, Salim Safurdeen.; Cates, Ward.; Coletti, Anne S.; Derbyshire, Janet.; Dorflinger, Laneta J.; Feldblum, Paul J.; Gabelnick, Henry.; Halpern, Vera Grigorieva.; Jespers, Vicky.; Kharsany, Ayesha Bibi Mahomed.; McCormack, Sheena.; Nunn, Andrew.; McGowan, Ian M.; Omar, Rabeea F.; Padian, Nancy S.; Pedneault, Louise.; Robbiani, Melissa Pope.; Sailer, James.; Taylor, Douglas.; Tolley, Elizabeth E.; Van Damme, Lut.; Vermund, Sten H.; van de Wijgert, Janneke.
No abstract available.
The future role of rectal and vaginal microbicides to prevent HIV infection in heterosexual populations: implications for product development and prevention.
(BMJ publishing group., 2011) Boily, Marie-Claude.; Dimitrov, Dobromir.; Abdool Karim, Salim Safurdeen.; Masse, Benoit.
Objectives. To compare the potential impact of rectal (RMB), vaginal (VMB) and bi-compartment (RVMB) (applied vaginally and protective during vaginal and anal intercourse) microbicides to prevent HIV in various heterosexual populations. To understand when a RMB is as useful than a VMB for women practicing anal intercourse (AI). Methods. Mathematical model was used to assess the population-level impact (cumulative fraction of new HIV infections prevented (CFP)) of the three different microbicides in various intervention scenarios and prevalence settings. We derived the break-even RMB efficacy required to reduce a female’s cumulative risk of HIV infection by the same amount than a VMB. Results. Under optimistic coverage (fast roll-out, 100% uptake), a 50% efficacious VMB used in 75% of sex acts in population without AI may prevent -33% (27, 42%) new total (men and women combined) HIV infections over 25 years. The 25-year CFP reduces to -25% (20, 32%) and 17% (13, 23%) if uptake decreases to 75% and 50%, respectively. Similar loss of impact (by 25% - 50%) is observed if the same VMB is introduced in populations with 5% - 10% AI and for RRRAI=4-20. A RMB is as useful as a VMB (ie, break-even) in populations with 5% AI if RRRAI=20 and in populations with 15% - 20% AI if RRRAI=4, independently of adherence as long as it is the same with both products. The 10-year CFP with a RVMB is twofold larger than for a VMB or RMB when AI=10% and RRRAI=10. Conclusions. Even low AI frequency can compromise the impact of VMB interventions. RMB and RVMB will be important prevention tools for heterosexual populations.
Safety and effectiveness of BufferGel and 0.5% PRO 2000 gel for the prevention of HIV infection in women.
(Lippincott Williams & Wilkins., 2010) 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.
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.
Utility of colposcopy in a phase 2 portion of a microbicide clinical trial of BufferGel and 0.5% PRO 2000 Gel.
(BioMed Central / International AIDS Society., 2012) Chirenje, Zvavahera Mike.; Masse, Benoit.; Maslankowski, Lisa.; Ramjee, Gita.; Coletti, Anne S.; Tembo, Tchangani.; Magure, Tsitsi M.; Soto-Torres, Lydia.; Kelly, Cliff.; Hillier, Sharon Louise.; Abdool Karim, Salim Safurdeen.
Background: The majority of new HIV infections are acquired through heterosexual transmission. There is urgent need for prevention methods to compliment behavior change and condom use. Topical microbicide represent a potential strategy for reduction of HIV transmission in women. Methods: Monthly Colposcopy evaluations were performed during pelvic examinations among 299 women enrolled in the Phase 2 portion of HPTN 035 study at four sites (1 in USA, 3 in Southern Africa). This was a phase 2/2b, multisite, randomized, and controlled clinical trial with four arms: BufferGel, 0.5% PRO2000 Gel, placebo gel and no gel. At two of the sites, pelvic examinations were conducted by the use of naked eye without colposcopy. Results: A colposcopy finding of any kind was detected in 48% of participants at baseline compared to 40% at 3 months (p=0.04). The lower rates were also observed in vaginal discharge (22% at baseline, 16% at 3 months, p=0.06), erythema (15% at baseline, 8% at 3 months, p=0.004). The trend towards significance at p=0.05 disappear when utilizing stringent statistical significance levels. A pelvic finding of any kind was detected in 71% of colposcopy participants compared to 41% of participants who had naked eye examination only conducted at two sites that performed both colposcopy and naked eye without colposcopy. Use of colposcopy yielded significantly higher rates of participants with deep epithelial disruption, erythema and ecchymosis.We observed no cases of incident Chlamydia, Gonorrhea, or Syphilis during the three month follow up. There were 2 cases of incident HIV during 3-month study period neither of which was associated with any abnormal colposcopy evaluation findings. Conclusion: No safety signals were observed in the 4 study arms, allowing seamless transition from phase 2 to 2b. Colposcopy utility in microbicide clinical trials has minimal value given high rates of background noise findings of no relevant clinical significance.