Browsing by Author "Chirenje, Zvavahera Mike."

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The fourth generation AlereTM HIV Combo rapid test improves detection of acute infection in MTN-003 (VOICE) samples.
(Journal of Clinical Virology, 2017-09) Livant, Edward.; Heaps, Amy.; Kelly, Cliff.; Maharaj, Rashika.; Samsunder, Natasha.; Nhlangulela, Lindiwe.; Karugaba, Patrick.; Panchia, Ravindre.; Marrazzo, Jeanne M.; Chirenje, Zvavahera Mike.; Parikh, Urvi M.
Abstract available in pdf.
Mucosal escherichia coli bactericidal activity and immune mediators are associated with HIV-1 seroconversion in women participating in the HPTN 035 trial.
(Oxford University Press on behalf of the Infectious Diseases Society of America., 2012) Dezzutti, Charlene S.; Richardson, Barbra Ann.; Marrazzo, Jeanne M.; Tugetman, Jessica.; Ramjee, Gita.; Taha, Taha E.; Chirenje, Zvavahera Mike.; Abdool Karim, Salim Safurdeen.; Hillier, Sharon Louise.; Herold, Betsy C.
The mucosal environment may impact the risk for human immunodeficiency virus type 1 (HIV-1) acquisition. Immune mediators were measured in vaginal fluid collected from HPTN 035 participants who acquired HIV-1 and from those who remained HIV-1 negative (controls). Mediator concentrations were similar in samples obtained before as compared to after HIV-1 acquisition in the 8 seroconverters. Compared with controls, seroconverters were more likely to have detectable levels of HβD-2 (odds ratio [OR], 2.39; P = .005) and greater Escherichia coli bactericidal activity (OR, 1.22; P = .01) prior to seroconversion. E. coli bactericidal activity remained significant in a multivariable analysis (P = .02) and may be a biomarker for HIV-1 acquisition.
Oral and injectable contraceptive use and HIV acquisition risk among women in four African countries : a secondary analysis of data from a microbicide trial.
(Elsevier., 2016) Balkus, Jennifer E.; Brown, Elizabeth R.; Hillier, Sharon Louise.; Coletti, Anne S.; Ramjee, Gita.; Mgodi, Nyaradzo.; Makanani, Bonus.; Reid, Cheri.; Martinson, Francis E.; Soto-Torres, Lydia.; Abdool Karim, Salim Safurdeen.; Chirenje, Zvavahera Mike.
Abstract available in pdf.
Risk factors for incidence of sexually transmitted infections among women in a human immunodeficiency virus chemoprevention trial : VOICE (MTN-003).
(American Sexually Transmitted Diseases Association., 2017) Chirenje, Zvavahera Mike.; Gundacker, Holly M.; Richardson, Barbra Ann.; Rabe, Lorna K.; Gaffoor, Zakir.; Nair, Gonasagrie.; Mirembe, Brenda Gati.; Piper, Jeanna M.; Hillier, Sharon Louise.; Marrazzo, Jeanne M.
Abstract available in pdf.
Risk of HIV-1 acquisition among women who use different types of injectable progestin contraception in South Africa: a prospective cohort study.
(Elsevier., 2015) Noguchi, Lisa M.; Richardson, Barbra Ann.; Baeten, Jared M.; Hillier, Sharon Louise.; Balkus, Jennifer E.; Chirenje, Zvavahera Mike.; Bunge, Katherine.; Ramjee, Gita.; Nair, Gonasagrie.; Palanee-Phillips, Thesla.; Selepe, Pearl.; van der Straten, Ariane.; Parikh, Urvi M.; Gomez, Kailazarid.; Piper, Jeanna M.; Watts, Heather D.; Marrazzo, Jeanne M.
Abstract available
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.
Tenofovir-based preexposure prophylaxis for HIV infection among African women.
(Massachusetts Medical Society., 2015) Marrazzo, Jeanne M.; Ramjee, Gita.; Richardson, Barbra Ann.; Gomez, Kailazarid.; Mgodi, Nyaradzo.; Nair, Gonasagrie.; Palanee, Thesla.; Nakabiito, Clemensia.; van der Straten, Ariane.; Noguchi, Lisa M.; Hendrix, Craig W.; Dai, James Y.; Ganesh, Shayhana.; Mkhize, Baningi.; Taljaard, Marthinette.; Parikh, Urvi M.; Piper, Jeanna M.; Mâsse, Benoît.; Grossman, Cynthia.; Rooney, James.; Schwartz, Jill L.; Watts, Heather D.; Marzinke, Mark Albert.; Hillier, Sharon Louise.; McGowan, Ian M.; Chirenje, Zvavahera Mike.
Abstract available in pdf.
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.