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The European & Developing Countries Clinical Trials Partnership (EDCTP) http://www.edctp.org/ funds clinical research to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials. The EDCTP is funding two major CAPRISA studies: CAPRISA 012 and CAPRISA 018 studies. These projects are part of the EDCTP2 programme supported by the European Union.
CAPRISA 012 trial https://www.caprisa.org/Pages/CAPRISAStudies
is a phase I/II trial conducted in three parts. The first part of the study, CAPRISA 012A, is a double blinded, randomized, placebo- controlled phase I trial assessing the safety and pharmacokinetic profile of the monoclonal antibodies, PGT121 and VRC07-523.LS administered subcutaneously in HIV negative women and is currently underway. All 45 participants have now been enrolled into the study, with 100% retention to date. Part B is a phase I study that will assess the safety, pharmacokinetics and acceptability of CAP256V2LS as well as the combination of the two bNAbs (CAP256V2LS + VRC07-523LS and CAP256V2LS + PGT121). Based on the phase I data from both CAPRISA 012A and CAPRISA 012B, one or both bNAb combinations will then be selected, based on matched pharmacokinetics, to proceed to the phase II trial, CAPRISA 012C, which will assess extended safety and obtain an estimate of efficacy in preventing HIV infection, in 606 (909 if both combinations go forward) young South African and Zambian women. The overall goal of the CAPRISA 012 trial is to develop a combination of two anti-HIV monoclonal antibodies as a new, safe and effective long-acting HIV prevention technology, principally for women, in order to alter the course of the HIV epidemic in Africa. This trial is co-funded by the South African Medical Research Council, the South African Department of Health, the Department of Science and Innovation and the National Research Foundation.
CAPRISA 018 study https://www.caprisa.org/Pages/CAPRISAStudies
is a phase I/II trial to assess the safety, acceptability, tolerability and pharmacokinetics of a sustained-release tenofovir alafenamide (TAF) sub-dermal implant for HIV prevention in women. This implant combines two well-established elements; a) TAF, which is a licenced antiretroviral drug widely used in HIV treatment, and b) a sub-dermal implant, which is widely used as a route of administration for contraception. This trial is co-funded by the South African Medical Research Council, the South African Department of Health, and the Department of Science and Innovation. Cipla Ltd provide an in-kind contribution through the donation of study drug.
1. Amsterdam Institute for Global Health and Development (AIGHD), Netherlands
2. Medical Department, Division of Infectious Diseases and Pneumology - Charité- Universitätsmedizin, Germany
3. Statens Serum Institut (SSI), Denmark
Study duration : 24 months
For any study related questions or data access please contact Prof Ayesha Kharsany (email: firstname.lastname@example.org)
This study will build on existing global research but fill an important gap in characterizing COVID-19 disease in the sub-Saharan African region. The research will enhance and refine our understanding of SARS-CoV-2 transmission dynamics, natural history and disease progression in a setting that has a high burden of HIV and TB. In addition, the comprehensive laboratory validation testing studies will supplement the gold standard RTPCR testing and provide options for rapid diagnosis COVID-19. Combined, this study will help guide the South African response to the COVID-19 outbreak.
Prof Ayesha Kharsany (PI)
Dr Aida Sivro (co-PI)
Ms Natasha Samsunder (Director, Laboratories)
2. Study: PrEP- Underlying Mucosal Immunity Before and After (PUMBA) PUMBA focuses on unravelling the immune correlates of risk or protection for HIV acquisition in the genital tracts and systemically in young African women who used antivirals as pre-exposure prophylaxis (PrEP) to prevent HIV. With the likely advent of combination HIV prevention strategies that include both vaccines and PrEP, understanding the effect that PrEP may have on the humoral immunity, inflammatory profiles and the microbiome in the genital tract and systemically may have important implications for efficacy of candidate HIV vaccines (Dr Desh Archary, Senior Fellowship)
3. CAPRISA 094 TRIAD Study, is a phase IV multi-centre, multi-country operational study to assess the effectiveness, feasibility, acceptability, and cost effectiveness of the GeneXpert MTB/XDR (Xpert MTB/XDR; Cepheid) assay for rapid triage-and-treatment with short, all- oral drug-resistant TB (DR-TB) treatment. The study will enrol 1280 participants across 9 clinical research study sites in South Africa, Nigeria and Ethiopia. The Xpert XDR assay is a rapid genotypic test which will be implemented as a reflex test to detect resistance to isoniazid, fluoroquinolones and second-line injectable agents to provide rapid genotypic susceptibility testing for DR-TB. The Xpert XDR assay will guide the selection of appropriate, all-oral DR-TB treatment regimens of the shortest possible duration. The tuberculosis molecular bacterial load assay (TB-MBLA) will be used as an adjunct to provide bacillary load monitoring over the course of treatment and assess real-time treatment response. Operational research will provide information about the feasibility, acceptability and cost-effectiveness to inform policies and guidelines for programmatic implementation of the triage-and-treat model. Collectively, the study will leverage on recent novel developments in the DR-TB diagnostic and treatment arena ensuring rapid delivery and uptake of these innovations into clinical practice in settings most afflicted by the disease.
Two CAPRISA scientists have been awarded EDCTP Senior Grant Fellowships and four Career Development Fellowships http://www.edctp.org/call/senior-fellowships-4/
Dr Benjamin Chimukangara (PhD) - Career Development Fellow. Study: Monitoring of HIV drug resistance in South Africa and innovative approaches to HIV drug resistance testing (HIVDR-MIT).
Co-funders of the CAPRISA 012 and CAPRISA 018 Trials