It has been a major accomplishment for our Clinical Trials Unit (CTU) at Instituto de Pesquisa Clinica Evandro Chagas (IPEC) – FIOCRUZ – to become affiliated with the AIDS Clinical Trials Group (ACTG). We joined the network in 2002, when the first international ACTG study – A5175 – started to be developed. Along these years, we have been successful in building a well-trained and dedicated multidisciplinary team that is able to meet the high-performance standards required by ACTG. Besides the highly experienced study coordinators, clinicians, pharmacists, nurses, and laboratory technologists and community educators, our CTU receives the support of a community advisory board that represents our diverse community.
Our CTU is based at IPEC, a 90 year old institution fully dedicated to clinical research in infectious diseases. IPEC is one of the 17 research institutes that integrate the Oswaldo Cruz Foundation (FIOCRUZ). FIOCRUZ is a public health institution for research and development in biomedical sciences. It is part of the Brazilian Ministry of Health, being the largest public health institution in Latin America.
The IPEC site is one of the leading international sites in the ACTG network. Since we joined the network, we have participated in several studies, having started with A5175 and its associated studies the A5185, A5190, and A5199. Thereafter, the team has also participated in other ACTG studies including A5221, 5227, A5240, A5234, A5243, A5253, 5255, and A5259. Notably, our site was one of the highest accruing sites for A5275, A5227, and A5240. In the coming year, we hope to participate in A5271, A5274, A5263, A5264, A5273, A5288 (our own site PI, Dr. Beatriz Grinsztejn is the co-chair of the protocol), A5295, and A5298.
The site’s choice of protocols closely mirrors the greatest research needs of Brazil, and we prioritize antiretroviral therapy strategy studies, tuberculosis, and HPV studies.
Tuberculosis still stands as a disconcerting serious public health problem, as this disease is still far from being controlled. Brazil ranks 16 out of the 22 countries that present 80% of the world’s TB cases. Among the AIDS cases reported to the Ministry of Health, tuberculosis represents the most important AIDS-associated disease and the main cause of death among AIDS patients. A strong and longstanding collaboration exists between IPEC/FIOCRUZ and several TB Control Programs in Rio de Janeiro State. Our site is a referral center for HIV/TB adult coinfected patients in Rio de Janeiro State. Therefore, studies related to TB diagnostics, prevention, and treatment are among those with the highest priority.
At IPEC we have available inpatient and outpatient facilities, a day hospital, a well-established diagnostic center, a data management unit, a dedicated clinical trials pharmacy, a specimen processing laboratory, and a biological specimen repository. This high-level research infrastructure contributes to a high recruitment and a very low rate of lost to follow up of study patients. We are truly proud to be part of the network.