Assessing the safety and pharmacokinetics of the monoclonal antibodies, VRC07-523LS and PGT121 in HIV negative women in South Africa: study protocol for the CAPRISA 012A randomised controlled phase I trial by Nigel Garrett, Sharana Mahomed, Edmund Capparelli, Cheryl Baxter, Nonhlanhla Yende Zuma, Tanuja Gengiah, Derseree Archary, Penny Moore, Natasha Samsunder, Dan H Barouch, John Mascola, Julie Ledgerwood, Lynn Morris, Salim Abdool Karim

“…Going forward, the aim is to select the ideal dose and/or monoclonal antibody for co-formulation and testing with CAP256-VRC26.25LS, a potent monoclonal antibody against subtype C virus, in an efficacy trial.Methods and analysis CAPRISA 012A is a randomised, double blinded, placebo-controlled phase I trial to assess the safety and PK profile of two mAbs, VRC07-523LS and PGT121 administered SC to 35 young HIV negative women at low risk for HIV infection. …”
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Extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV-negative women: study protocol for the randomised, placebo-controlled double-blinded, phase 2 CAPRISA 012C trial by Nigel Garrett, Farzana Osman, Sharana Mahomed, Edmund Capparelli, Nonhlanhla Yende Zuma, Derseree Archary, Penny Moore, Natasha Samsunder, Lynn Morris, Salim Abdool Karim, Catherine Hankins, Carolyn Williamson, Bruno Pozzetto, Kevin Carlton, Richard A Koup, Quarraisha Abdool Karim, Leila Mansoor, Tanuja Narayansamy Gengiah, Ishana Harkoo, Precious Radebe, Izukanji T Sikazwe, Disebo Potloane, Nqobile Myeni, Lucio Gama, Sandeep Narpala, Leonid Serebryannyy, Nicole Doria-Rose

“…The completed CAPRISA 012A and 012B phase 1 trials provided critical data for the CAPRISA 012C trial, which is divided into parts A and B. …”
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Assessing the safety and pharmacokinetics of the anti-HIV monoclonal antibody CAP256V2LS alone and in combination with VRC07-523LS and PGT121 in South African women: study protocol for the first-in-human CAPRISA 012B phase I clinical trial by Nigel Garrett, Sharana Mahomed, Edmund Capparelli, Cheryl Baxter, Tanuja Gengiah, Derseree Archary, Penny Moore, Natasha Samsunder, Dan H Barouch, John Mascola, Julie Ledgerwood, Lynn Morris, Salim Abdool Karim, Catherine Hankins, Quarraisha A Karim, Nonhlanhla Y Zuma, Carolyn Williamson, Patricia E Fast, Bruno Pozzetto, Kevin Carlton, Nicole Doria-Rose

“…This bNAb was subsequently structurally engineered and the clinical variant is now referred to as CAP256V2LS.Methods and analysis CAPRISA 012B is the second of three trials in the CAPRISA 012 bNAb trial programme. …”
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Evaluation of Metronidazole Resistance of Vaginal Swab Isolates from South African Women Treated for Bacterial Vaginosis by Timo Schwebs, Ann-Katrin Kieninger, Lenka Podpera Tisakova, Vera Oberbauer, Rocío Berdaguer, Andile Mtshali, Gugulethu Mzobe, Anne Rompalo, Adrian Mindel, Marothi Letsoalo, Nigel Garrett, Sinaye Ngcapu, Lorenzo Corsini

“…<b>Background/Objectives</b>: The high recurrence rate of bacterial vaginosis (BV) after antibiotic treatment is at least partially attributed to resistant bacteria. The CAPRISA 083 (CAP083) study investigated the influence of metronidazole (MTZ) treatment on the vaginal microbiome in 56 South African women diagnosed with BV. …”
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In‐utero exposure to tenofovir‐containing pre‐exposure prophylaxis and bone mineral content in HIV‐unexposed infants in South Africa by Kerusha Reddy, Kimesh L. Naidoo, Carl Lombard, Zukiswa Godlwana, Alicia C. Desmond, Richard Clark, James F. Rooney, Glenda Gray, Dhayendre Moodley

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Protocol for a randomised feasibility study of Point-Of-care HIV viral load testing to Enhance Re-suppression in South Africa: the POwER study by Sarah Tonkin-Crine, Nigel Garrett, Jienchi Dorward, Hope Ngobese, Lara Lewis, Natasha Samsunder, Paul K Drain, Yukteshwar Sookrajh, Richard Lessells, Fathima Sayed, Elliot Bulo, P Moodley

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Ecology meets reproductive medicine in HIV prevention: the case for geography-informed approaches for bacterial vaginosis in Africa by Jo-Ann S. Passmore, Jo-Ann S. Passmore, Jo-Ann S. Passmore, Sinaye Ngcapu, Serah Gitome, Brian R. Kullin, Kirsten Welp, Darren P. Martin, Disebo Potloane, Monalisa T. Manhanzva, Moses M. Obimbo, Katherine Gill, Katherine Gill, Mellissa Le Fevre, Anna-Ursula Happel, Anna-Ursula Happel, Heather B. Jaspan, Heather B. Jaspan, Heather B. Jaspan, Margaret Kasaro, Margaret Kasaro, Margaret Kasaro, Elizabeth A. Bukusi, Elizabeth A. Bukusi

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Does voluntary medical male circumcision protect against sexually transmitted infections among men and women in real-world scale-up settings? Findings of a household survey in KwaZ... by Brendan Maughan-Brown, Stephanie Davis, Carlos Toledo, Lara Lewis, Kassahun Ayalew, Ayesha B M Kharsany

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Disclosure of oral pre-exposure prophylaxis use for HIV prevention among women enrolled in a contraceptive study: qualitative findings from Durban, South Africa by Ivana Beesham, Mags Beksinska, Cecilia Milford, Cecilia Milford, Leila E. Mansoor

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Factors associated with HIV in younger and older adult men in South Africa: findings from a cross-sectional survey by Frank Tanser, Gavin George, Cherie Cawood, David Khanyile, Kaymarlin Govender, Ayesha BM Kharsany, Lara Lewis, Sean Edward Beckett

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Understanding Methods for Estimating HIV-Associated Maternal Mortality by James E. Rosen, Isabelle de Zoysa, Karl Dehne, Viviana Mangiaterra, Quarraisha Abdool-Karim

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Tuberculosis: treatment failure, or failure to treat? Lessons from India and South Africa by Nesri Padayatchi, Amrita Daftary, Naressa Naidu, Madhukar Pai

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Navigating DR-TB Treatment care: a qualitative exploration of barriers and facilitators to retention in care among people with history of early disengagement from drug-resistant tu... by Ndiviwe Mphothulo, Sindisiwe Hlangu, Jennifer Furin, Mosa Moshabela, Marian Loveday

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Coronavirus Host Genomics Study: South Africa (COVIGen-SA) by Andrew K. May, Heather Seymour, Harriet Etheredge, Heather Maher, Marta C. Nunes, Shabir A. Madhi, Simiso M. Sokhela, W. D. Francois Venter, Neil Martinson, Firdaus Nabeemeeah, Cheryl Cohen, Jocelyn Moyes, Sibongile Walaza, Stefano Tempia, Jackie Kleynhans, Anne von Gottberg, Jeremy Nel, Halima Dawood, Ebrahim Variava, Stephen Tollman, Kathleen Kahn, Kobus Herbst, Emily B. Wong, Caroline T. Tiemessen, Alex van Blydenstein, Lyle Murray, Michelle Venter, June Fabian, Michéle Ramsay

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The feasibility, acceptability, appropriateness and impact of implementing person-centered communication for prevention of female genital mutilation in antenatal care settings in G... by Patrick Ndavi, Mamadou Dioulde Balde, Cecilia Milford, Vernon Mochache, Anne-Marie Soumah, Tammary Esho, Alpha Oumar Sall, Aissatou Diallo, Wisal Ahmed, Karin Stein, Jacqueline Chesang, Samuel Kimani, Joyce Jebet, Joyce Omwoha, James Munyao King’oo, Muna Abdi Ahmed, Ahmed Diriye, Christina Pallitto

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Impact of Motivational Enhanced Adherence Counseling and Point-of-Care Viral Load Monitoring on Viral Load Outcome in Women on Life-Long ART: A Randomized Pilot Study by Mercy T. Mutambanengwe-Jacob, Charles C. Maponga, K. Rivet Amico, Bernard Ngara, Nonhlanhla Yende-Zuma, Tariro D. Chawana, Teacler Nematadzira, Justice F. Gumbo, Tendayi Goverayi, Petronella Matibe, Bernadette V. Malunda, Jim Aizire, Taha E. Taha, Mary G. Fowler, Lynda Stranix-Chibanda

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Development of normal reference intervals for renal function in pregnancy: a secondary analysis of clinical trial data by Zandile Legoabe, Motshedisi Sebitloane, Carl Lombard, Megeshinee Naidoo, Glenda Gray, Dhayendre Moodley

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Triage test for all-oral drug-resistant tuberculosis (DR-TB) regimen: a phase IV study to assess effectiveness, feasibility, acceptability and cost-effectiveness of the Xpert MTB/X... by Kogieleum Naidoo, Derek J Sloan, Wilber Sabiiti, Bariki Mtafya, Stephen H Gillespie, Aderonke Agbaje, Nyanda Elias Ntinginya, Morten Ruhwald, Agnes Gebhard, Anushka Naidoo, Rubeshan Perumal, Getachew Tollera, Evaezi Okpokoro, Alash'le G Abimiku, Everdina W Tiemersma, Sabine M Hermans, Sophia B Georghiou, Kalkidan Yae, Shewki Moga, Hannelise Feyt, Takondwa Kachoka, Marothi P Letsoalo, Andrea M Cabibbe, Letitia Shunmugam, Daniela M Cirillo, Salah Foraida

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