Nigeria is close to becoming a trial site for new HIV drug study, as clinical trial experts from Merck Sharp and Dohme (MSD) would be in the country this week to ascertain the possibility.
The experts, led by Robert Burger will be visiting AIDS Prevention Initiative in Nigeria (APIN) Centre at Jos University Teaching Hospital (JUTH), where they are meeting members of the clinical trial team, led by the renown consultant physician, Professor John Idoko, of the University of Jos. They are expected to be in the country from August 25 to 27 prior to the commencement of the study at a later date.
MSD, had in a statement disclosed that its HIV drug, Isentress (raltegravir), was approved by US FDA in October 2007, and that the National Health Research and Ethics Committee (NHREC) and National Agency for Food and Drug Administration and Control (NAFDAC) have given their approval to the local study.
The study comes about two months after the Executive Director of Kampala, Uganda based Institute of Infectious Disease (IDI) told the public that most drug makers are not attracted to conducting trials in Nigeria because of infrastructural problems and the fact that HIV/AIDS is not as widespread in Nigeria as is the case with other countries where such studies are carried out.
According to him, the estimated three million people living with HIV in Nigeria would be diffused in the country’s huge population (140 million), unlike the situation in other countries in Africa where the population is far lower.
Earlier, director general of National Agency for the Control of AIDS in Nigeria (NACA), Professor Babatunde Osotimehin, had expressed his desires for Nigeria to be considered as trial sites for HIV medicines, including vaccine candidates.
Since the first reported case of HIV in 1986, the epidemic has continued to unleash a huge blow on the nation.
According to records, estimated 2.9 million Nigerians are currently infected with the virus. However, the introduction of Highly Active Antiretroviral Therapy (HAART), HIV/AIDS has become a manageable chronic disease and People Living With HIV/AIDS (PLWHA) can live normal and productive life.
Each antiretroviral drug has made its own important contribution to prolonging the life of patients infected with HIV.
However, no treatment approach is curative and all treatments eventually fail, either for reasons related to dose-limiting adverse events, non-compliance, the evolution of resistance or combination of all these.
The statement issued by MSD’s Nigerian representative, Mr. Bukola Johnson, stated that, "it is important to note that virtually in all fields of medicine where antimicrobials are used drug resistance is inevitable. The issue really is how soon and how widespread the resistance becomes and whether alternative therapy is available, and at what cost."
There is an acute medical need for novel and potent Anti Retroviral Therapy (ART), for ART experienced HIV-infected patients who are failing their current ART regimen and have limited or no therapeutic options, according to MSD.
Isentress
(raltegravir, formerly coded MK-0518) is an HIV integrase inhibitor, the first in its class, which is in phase III clinical development.
To date there are no approved drugs that target the integration stage of the HIV-1 lifecycle. Data from ongoing studies suggest that MK-0518 is generally safe and well tolerated and has the promise to be a clinically effective therapeutic option for chronic HIV infection in highly treatment experienced patients. Due to its novel mechanism of action, potent efficacy and tolerability, patients with advanced HIV and limited therapeutic options may benefit from early access to the drug.
However, it is important to carefully assess the risks versus potential benefits of using a drug before its safety profile has been completely characterised in clinical trials. It is in pursuant of these goals that MSD is sponsoring an expanded access, non-comparative, multi-centre, open-label, treatment use study titled "Early Access of MK-0518 in Combination With an Optimised Background Antiretroviral Therapy (OBT) in Highly Treatment Experienced HIV-1 Infected Patients With Limited to No Treatment Options."
In order to increase the likelihood that patients will respond to treatment, it is recommended that HIV infected patients failing their current regimen receive at least two new ARTs to which the patient’s virus is still sensitive. It recommended that this be based on genotypic/phenotypic resistance results and past treatment history if possible. The OBT in this study will consist of boosted Darunavir, an FDA approved and licensed ARV.
MSD has contracted Parexel International Coorporation, a company with decades of experience, deep expertise, and the global resources required to handle studies of any size, anywhere in the world to manage the multi-centre study in sub- Saharan Africa.