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IHVN/IRCE, ISN Products Nigeria Ltd partner on Non-Communicable Diseases Research in PLHIV

 


The International Research Center of Excellence (IRCE) at the Institute of Human Virology Nigeria (IHVN) and ISN Products Nigeria Limited have begun a partnership to research into non-communicable diseases among People Living with HIV (PLHIV) in Nigeria.

The study is to take place at Kubwa General Hospital Abuja, University of Abuja Teaching Hospital, Nyanya General Hospital, Asokoro District Hospital and Police Hospital, Garki, Abuja. It seeks to estimate the burden and progression of non-communicable diseases including hypertension, diabetes, prostate and cervical cancer, and chronic obstructive pulmonary diseases among PLHIV over a period of two years.

According to IRCE Executive Director and Principal Investigator of the ISN-NCD study, Prof. Alash’le Abimiku, the study will clearly characterize risk factors that may trigger future development of Non-Communicable Diseases (NCDs) among PLHIVs.

“We aim to recruit and follow up 200 newly diagnosed HIV positive clients and 200 people who are HIV negative for a period of two years. This cohort of individuals may also be used to study diverse disease outcomes in the future,” Prof. Abimiku stated.

 “The study is also significant because it will characterize and explore clinical, behavioural and psychosocial risk factors of NCDs among the newly diagnosed HIV participants compared to those with negative results. All participants will be assessed for willingness to participate in future HIV vaccine and cure research with samples stored for future genetic research,” Dr. Patrick Dakum, the Chief Executive Officer of IHVN said.

Executive Director ISN Products Nigeria Ltd, Mr. Felix Ofungwu stated that the research aligns to their organization’s objective to contribute a significant portion of their yearly profit to research and development.

“We are excited about this sponsorship, primarily because the ISN-NCD study addresses two critical disease areas of HIV and Non-Communicable Diseases. ISN stands for quality and innovation in the medical diagnostics industry and we recognize that research provides the bedrock for innovative medical solutions,” he said.

ISN Products Nigeria Ltd. is funding the research to be implemented by IHVN/IRCE. The company, a leading indigenous medical diagnostic company, has also donated equipment and reagents to Kubwa General Hospital, which is the central laboratory location for the research were samples from all study sites will be analysed.

Equipment contributed are a Cobas C111 Chemistry Analyzer, an AVL Electrolyte Analyzer, a BC 5150 Haematology Analyzer and a Merck Lab Water Unit.

IRCE is a center of excellence established in 2016 by IHVN. The collaboration with ISN Products Nigeria Ltd is in line with the center’s mandate of promoting public/private partnership for quality health services, capacity building and research in West Africa.

For this ISN-NCD study, IRCE researchers, Drs. Elima Jedy-Agba, Evaezi Okpokoro and Gbenga Kayode will serve as co-investigators on the study and coordinate the site activities at the five participating hospitals.

 

Recently Funded Research Grants at IRCE:

THE COHIVE STUDY

 

Dr Eriobu C. Nnakelu is the Nigerian principal investigator for the Covid 19 Outcomes in HIV Evaluation in Resource Limited Settings (COHIVE) study. This study is a sub-study to the parent D2eft study, which is a multi-site, open label, randomized clinical trial. D2eft is evaluating the clinical, immunologic, virologic and quality of life measures of enrolled study participants randomized to  three different  combination regimens of 2nd line ART in adult HIV patients who have failed 1st line treatment. With the advent of the Covid-19 pandemic the COHIVE study was developed. It pools together the sample sizes of 5 parent protocols, namely D2eft, ADVANCE, DolPHIN2, NAMSAL and WRHI 052 to characterize the clinical features and course of symptomatic COVID-19 in people living with HIV (PLWH) described overall and by HIV and comorbid factors including pregnancy.

The Primary Goals of COHIVE include:

– To describe the incidence of symptomatic COVID-19 across these cohorts, by region and by ART.

– To characterize the clinical outcomes of symptomatic COVID-19 infection in PLWH.

– To evaluate clinical risk factors for hospitalization, severe illness (ICU admission or equivalent), or death (ordinal endpoint and death individually) in those with symptomatic COVID-19

– To evaluate duration of carriage and infectivity of SARS-CoV-2 in people with HIV with symptomatic COVID-19

– To explore in a preliminary manner the effect of pre-existing therapy with protease inhibitors darunavir/ritonavir or lopinavir/ritonavir on clinical outcomes of symptomatic COVID-19 infection, in comparison with those receiving other ART.

COHIVE will be implemented from 2020 to 2021 with funding support from UNITAID through the sponsor the Kirby Institute, University of New South Wales (UNSW).

 

The ITAC Study
 
 
Dr Eriobu Nnakelu is the Nigeria Principal investigator for the ITAC study. The ITAC (Inpatient Treatment with Anticoronavirus Immunoglobulin) study is an International multicenter, adaptive, randomized double-blind, placebo- controlled trial of the safety, tolerability and efficacy of anti-Coronavirus hyperimmune intravenous immunoglobulin for the treatment of adult hospitalized patients at onset of clinical progression of COVID-19. This trial will involve sites around the world strategically chosen to ensure rapid enrollment and will evaluate the use of hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to Remdesivir as the standard of care, for preventing further disease progression and mortality related to COVID-19.
 
The primary endpoint of this trial in hospitalized patients is an ordinal outcome based on the patient’s clinical status on Day 7, while the secondary endpoints include pulmonary only and thrombotic only components of the primary ordinal outcome among other assessments. Due to the impact of COVID 19, this study will last between 12 – 16 months and its potential impact may provide a pathway to a treatment option for a disease with narrow therapeutic alternatives for patients at risk of progressing in their clinical outcomes.
 
The ITAC study is funded by the US National Institute of health (NIH) and the US National Institute of Allergy and Infectious Diseases (NIAID) with the University of Minnesota (UoM) as the sponsor. It will be implemented in Nigeria by the clinical trial team of the International Research Center of Excellence (IRCE), in collaboration with the Nigeria Covid 19 Research Consortium (NCRC), National Hospital Abuja and the University of Abuja Teaching Hospital Gwagwalada.
 
 
 

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