Browsing by Author "Chirenje ZM"

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Corrigendum to "oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial" [Contraception 2016; 93 (1): 25-31].
(2016-Jul) Balkus JE; Brown ER; Hillier SL; Coletti A; Ramjee G; Mgodi N; Makanani B; Reid C; Martinson F; Soto-Torres L; Abdool Karim SS; Chirenje ZM; College of Medicine, University of Malawi, Blantyre, Malawi.; National Institutes of Health, Bethesda, MD, USA.; FHI360, Durham, NC, USA.; Department of Obstetrics, Gynecology and Reproductive Sciences and the Magee-Women's Research Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.; University of North Carolina Project, Kamuzu Central Hospital, Lilongwe, Malawi.; Centre for the AIDS Program of Research in South Africa, Doris Duke Medical Research Institute, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Congella, South Africa; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.; University of Zimbabwe - University of California San Francisco Research Program, Harare, Zimbabwe.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; HIV Prevention Research Unit, South Africa Medical Research Council, Durban, South Africa.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: jbalkus@fhcrc.org.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
Oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial.
(2016-Jan) Balkus JE; Brown ER; Hillier SL; Coletti A; Ramjee G; Mgodi N; Makanani B; Reid C; Martinson F; Soto-Torres L; Abdool Karim SS; Chirenje ZM; College of Medicine, University of Malawi, Blantyre, Malawi.; National Institutes of Health, Bethesda, MD, USA.; FHI360, Durham, NC, USA.; Department of Obstetrics, Gynecology and Reproductive Sciences and the Magee-Women's Research Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.; University of North Carolina Project, Kamuzu Central Hospital, Lilongwe, Malawi.; Centre for the AIDS Program of Research in South Africa, Doris Duke Medical Research Institute, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Congella, South Africa; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.; University of Zimbabwe - University of California San Francisco Research Program, Harare, Zimbabwe.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; HIV Prevention Research Unit, South Africa Medical Research Council, Durban, South Africa.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: jbalkus@fhcrc.org.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
OBJECTIVE: To assess the effect of oral and injectable contraceptive use compared to nonhormonal contraceptive use on HIV acquisition among Southern African women enrolled in a microbicide trial. STUDY DESIGN: This is a prospective cohort study using data from women enrolled in HIV Prevention Trials Network protocol 035. At each quarterly visit, participants were interviewed about self-reported contraceptive use and sexual behaviors and underwent HIV testing. Cox proportional hazards regression was used to assess the effect of injectable and oral hormonal contraceptive use on HIV acquisition. RESULTS: The analysis included 2830 participants, of whom 106 became HIV infected (4.07 per 100 person-years). At baseline, 1546 (51%) participants reported using injectable contraceptives and 595 (21%) reported using oral contraceptives. HIV incidence among injectable, oral and nonhormonal contraceptive method users was 4.72, 2.68 and 3.83 per 100 person-years, respectively. Injectable contraceptive use was associated with a nonstatistically significant increased risk of HIV acquisition [adjusted hazard ratio (aHR)=1.17; 95% confidence interval (CI) 0.70, 1.96], while oral contraceptive use was associated with a nonstatistically significant decreased risk of HIV acquisition (aHR=0.76; 95% CI 0.37,1.55). CONCLUSION: In this secondary analysis of randomized trial data, a marginal, but nonstatistically significant, increase in HIV risk among women using injectable hormonal contraceptives was observed. No increased HIV risk was observed among women using oral contraceptives. Our findings support the World Health Organization's recommendation that women at high risk for acquiring HIV, including those using progestogen-only injectable contraception, should be strongly advised to always use condoms and other HIV prevention measures. IMPLICATIONS: Among Southern African women participating in an HIV prevention trial, women using injectable hormonal contraceptives had a modest increased risk of HIV acquisition; however, this association was not statistically significant. Continued research on the relationship between widely used hormonal contraceptive methods and HIV acquisition is essential.
Protein Dose-Sparing Effect of AS01B Adjuvant in a Randomized Preventive HIV Vaccine Trial of ALVAC-HIV (vCP2438) and Adjuvanted Bivalent Subtype C gp120.
(2024-Aug-16) Chirenje ZM; Laher F; Dintwe O; Muyoyeta M; deCamp AC; He Z; Grunenberg N; Laher Omar F; Seaton KE; Polakowski L; Woodward Davis AS; Maganga L; Baden LR; Mayer K; Kalams S; Keefer M; Edupuganti S; Rodriguez B; Frank I; Scott H; Stranix-Chibanda L; Gurunathan S; Koutsoukos M; Van Der Meeren O; DiazGranados CA; Paez C; Andersen-Nissen E; Kublin J; Corey L; Ferrari G; Tomaras G; McElrath MJ; Department of Medicine, University of Rochester, Rochester, NewYork, USA.; SanFrancisco Department of Public Health, San Francisco, California, USA.; Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.; Faculty of Medicine and Health Science, University of Zimbabwe Clinical Trials Research Centre, University of Zimbabwe, Harare, Zimbabwe.; National Institute for Medical Research-Mbeya Medical Research Centre, Mbeya, Tanzania.; Division of Infectious Diseases, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Beth Israel Deaconess Medical Center, Harvard University, Boston, Massachusetts, USA.; Cape Town HIV Vaccine Trials Network Immunology Laboratory, Cape Town, South Africa.; Department of Obstetrics and Gynecology, University of California San Francisco, San Francisco, California, USA.; Department of Medicine, Emory University, Atlanta, Georgia, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.; Vaccine Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.; School of Medicine, University of Pennsylvania, Philadelphia, USA.; GSK, Wavre, Belgium.; GSK, Rixensart, Belgium.; Center for Human Systems Immunology, Duke University School of Medicine, Durham, North Carolina, USA.; Division of Infectious Diseases and HIV Medicine, Department of Medicine, Case Western Reserve University/University Hospitals, Cleveland Medical Center, Cleveland, Ohio, USA.; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.; Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.; Department of Surgery, Duke University Medical Center, Durham, North Carolina, USA.; The Fenway Institute, Fenway Health, Boston, Massachusetts, USA.; Centre for Infectious Diseases Research in Zambia, Livingstone, Zambia.; Sanofi Pasteur, Swiftwater, Pennsylvania, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: HVTN 120 is a phase 1/2a randomized double-blind placebo-controlled human immunodeficiency virus (HIV) vaccine trial that evaluated the safety and immunogenicity of ALVAC-HIV (vCP2438) and MF59- or AS01B-adjuvanted bivalent subtype C gp120 Env protein at 2 dose levels in healthy HIV-uninfected adults. METHODS: Participants received ALVAC-HIV (vCP2438) alone or placebo at months 0 and 1. At months 3 and 6, participants received either placebo, ALVAC-HIV (vCP2438) with 200 μg of bivalent subtype C gp120 adjuvanted with MF59 or AS01B, or ALVAC-HIV (vCP2438) with 40 μg of bivalent subtype C gp120 adjuvanted with AS01B. Primary outcomes were safety and immune responses. RESULTS: We enrolled 160 participants, 55% women, 18-40 years old (median age 24 years) of whom 150 received vaccine and 10 placebo. Vaccines were generally safe and well tolerated. At months 6.5 and 12, CD4+ T-cell response rates and magnitudes were higher in the AS01B-adjuvanted groups than in the MF59-adjuvanted group. At month 12, HIV-specific Env-gp120 binding antibody response magnitudes in the 40 μg gp120/AS01B group were higher than in either of the 200 μg gp120 groups. CONCLUSIONS: The 40 μg dose gp120/AS01B regimen elicited the highest CD4+ T-cell and binding antibody responses. Clinical Trials Registration . NCT03122223.