Browsing by Author "Ramjee, Gita."

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Bacterial vaginosis and the risk of trichomonas vaginalis acquisition among HIV-1 negative women.
(American Sexually Transmitted Diseases Association., 2014) Balkus, Jennifer E.; Richardson, Barbra Ann.; Rabe, Lorna K.; Taha, Taha E.; Mgodi, Nyaradzo.; Kasaro, Margaret Phiri.; Ramjee, Gita.; Hoffman, Irving F.; Abdool Karim, Salim Safurdeen.
Background: The vaginal microbiota may play a role in mediating susceptibility to sexually transmitted infections, including Trichomonas vaginalis (TV). Methods: Data were analyzed from HIV-1-seronegative women participating in HIV Prevention Trials Network Protocol 035. At quarterly visits for up to 30 months, participants completed structured interviews and specimens were collected for genital tract infection testing. T. vaginalis was detected by saline microscopy. Bacterial vaginosis (BV) was characterized by Gram stain using the Nugent score (BV = 7Y10; intermediate = 4Y6; normal = 0Y3 [reference group]). Cox proportional hazards models stratified by study site were used to assess the association between Nugent score category at the prior quarterly visit and TV acquisition. Results: In this secondary analysis, 2920 participants from Malawi, South Africa, United States, Zambia, and Zimbabwe contributed 16,259 follow-up visits. Bacterial vaginosis was detected at 5680 (35%) visits,and TV was detected at 400 (2.5%) visits. Adjusting for age, marital status, hormonal contraceptive use, unprotected sex in the last week and TV at baseline, intermediate Nugent score, and BVat the prior visit were associated with an increased risk of TV (intermediate score: adjusted hazard ratio [aHR], 1.73; 95% confidence interval [CI], 1.21Y2.19; BV: aHR, 2.40; 95% CI, 1.92Y3.00). Sensitivity analyses excluding 211 participants with TV at baseline were similar to those from the full study population (intermediate score: aHR, 1.54; 95% CI, 1.10Y2.14; BV: aHR, 2.23; 95% CI, 1.75Y2.84). Conclusions: Women with a Nugent score higher than 3 were at an increased risk for acquiring TV. If this relationship is causal, interventions that improve the vaginal microbiota could contribute to reductions in TV incidence.
HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial.
(Public Library of Science., 2017) Riddler, Sharon Anne.; Husnik, Marla.; Ramjee, Gita.; Premrajh, Anamika.; Tutshana, Bomkazi Onini.; Pather, Arendevi.; Siva, Samantha.; Jeenarain, Nitesha.; Nair, Gonasagrie.; Selepe, Pearl.; Kabwigu, Samuel.; Palanee-Phillips, Thesla.; Panchia, Ravindre.; Mhlanga, Felix.; Levy, Lisa.; Livant, Edward.; Patterson, Karen.; Elharrar, Vanessa.; Balkus, Jennifer E.
Abstract available in pdf.
HPTN 035 phase II/IIb randomised safety and effectiveness study of the vaginal microbicides BufferGel and 0.5% PRO 2000 for the prevention of sexually transmitted infections in women.
(BMJ., 2014) Guffey, M Bradford.; Richardson, Barbra Ann.; Husnik, Marla.; Makanani, Bonus.; Chilongozi, David.; Yu, Elmer.; Ramjee, Gita.; Mgodi, Nyaradzo.; Gomez, Kailazarid.; Hillier, Sharon Louise.; Abdool Karim, Salim Safurdeen.
Abstract available in pdf.
The impact of incident and prevalent herpes simplex virus-2 infection on the incidence of HIV-1 infection among commercial sex workers in South Africa.
(Lippincott Williams & Wilkins., 2004) Ramjee, Gita.; Williams, Brian G.; Gouws, Eleanor.; Van Dyck, Eddy.; De Deken, Benedicte.; Abdool Karim, Salim Safurdeen.
This study investigated the impact of prevalent and incident HSV-2 infection on the incidence of HIV-1 infection in a cohort of female commercial sex workers in KwaZulu-Natal, South Africa. Prior to a vaginal microbicide trial, 416 women were screened for antibodies to HIV-1 and herpes simplex virus-2 (HSV-2) infections and a questionnaire was used to establish behavioral, social, and demographic characteristics. A total of 187 HIV-1-seronegative women were followed up at monthly intervals when blood was drawn and used to detect HIV-1 and HSV-2 antibodies. The median duration of follow-up was 2.2 years. At screening 50% of the women were HIV-1 seropositive and 84% were HSV-2 seropositive. The hazards of HIV-1 among women who were HSV-2 seropositive or seronegative throughout, or among those who seroconverted during the study, were not significantly different. When HSV-2 seroconversion was analyzed as a time-dependent covariate, the hazard ratio for HIV-1 seroconversion was 6.0 (95% CI: 2.6–14.0) times greater among women with incident than among women with prevalent HSV-2 infections. Drawing on other recent studies these data suggest that incident HSV-2 infection increases the risk of HIV-1 infection; the effect wanes with time since infection; and the effect is significantly greater for men than it is for women.
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 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.
Studies on the mechanisms of proteinuria in kidney diseases of childhood.
(1994) Ramjee, Gita.; Adhikari, Miriam.; Coovadia, Hoosen Mahomed.
Abstract available in PDF.
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.