Azt clinical trials africa

Concurrent Medication: Excluded: Other anti-retroviral agents. Also patient must fall into one of the following categories: Have an HIV seronegative identical twin to serve as a bone marrow donor. Be a good risk candidate for bone marrow transplant. Contacts and Locations.

Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.

More Information. Layout table for additonal information ClinicalTrials. National Library of Medicine U. National Institutes of Health U. This information must also be disclosed to participants during the informed consent process.

It takes a holistic look into the ethical aspect of a clinical trial protocol while paying particular attention to the protection of the research participants.

All research involving human subjects including clinical trials must be approved by a HREC. In the Trovan study, it was established that the clinical trial protocol did not pass through ethical review process in Nigeria. It must be emphasised that clinical trial protocols must pass through ethical review and be approved in both the country of sponsorship and where the research would be conducted.

Ethical approval from the country of sponsorship does not substitute for ethical approval from the country where the research will be conducted. It is pertinent to acknowledge the efforts of the Nigerian government through the National Health Research Ethics Committee to promote ethical conduct of research in Nigeria.

In the same vein, it is important to appreciate the assistance of the Government of the United States of America through the Fogarty Center of the National Institute for Health that has provided grants for training in research ethics to Nigeria and many developing countries.

It is expected that HREC would review a clinical protocol using several benchmarks. Several documents have prescribed guidelines for ethical conduct of clinical trials and research in general.

These documents include. Nuffield Council on Bioethics. Most countries having adopted the ethical principles in these international documents have gone further to produce their own guidelines. What makes clinical research in developing countries ethical? The benchmarks of ethical research by Ezekiel Emanuel et al. The proposed clinical trial must have social or scientific value either to participants, the community or population they represent or the host country in order to justify the finite resources and risk exposure to some participants.

In international collaborative research, the research should be integrated with comprehensive capacity building, technology transfer and health-care delivery strategies that address significant local health problems and add value to local participation of research.

In a nut shell, the participants, researchers, host institution or even the country at large must have something to show for participating in the research. For example, a clinical trial that seeks to evaluate the efficacy of a test drug on a particular virus may require a PCR machine to assess viral load. If the host institution does not have a PCR machine, the proposed research should include acquisition of a PCR machine for the host institution in the research budget rather than collecting the samples to analyses abroad or elsewhere.

It is generally recognised that doing a study that lacks scientific validity is unethical. Therefore, for research to be ethical, it must have scientific validity. HREC should be competent to look into the scientific validity of a clinical trial protocol being reviewed. Flaws in scientific validity could include:. The ethical implication of doing a scientifically invalid research is that the time, resources, risk that patients underwent in the clinical trial will come to nothing since the results of the trial would be discredited based on lack of scientific validity.

This must be done based on the objectives of the clinical trials. The recruitment of vulnerable groups such as incarcerated persons, persons in low socio-economic class, pregnant women and children, must be justified based on the objectives of the study and the inherent benefits accruable to them. Conversely such vulnerable groups should not be denied participation in research if they would benefit from it. For example, use of non-invasive tests rather than an invasive test where both will give similar valid results.

There must be clear uncertainty of the efficacy of the test drug or the efficacy in a different population. It is unethical to continue to conduct clinical trials in a drug whose efficacy has been clearly established and there is no scientific reason to believe that available results cannot be generalised to other populations. All research involving human subjects must be reviewed by a competent ethics committee.

Following approval of the clinical trial, the HREC should also monitor the conduct of the trials through regular progress reports and site visits. Ethical review and oversight assures society that reasonable attempts have been made to minimise the potential impacts of these conflicting interests and ensure balanced judgments.

This is the cornerstone in the ethical conduct of research in general and clinical trials in particular. The informed consent document should contain the following aspects:. Procedure of the research, what shall be required of each participant and approximate total number of participants that would be involved in the research.

Consequences of participants' decision to withdraw from research and procedure for orderly termination of participation. Modality of providing treatments and action s to be taken in case of injury or adverse event s. Statement about sharing of benefits among researchers and whether this includes or exclude research participants. Detailed contact information including contact address, telephone, fax, e-mail and any other contact information of researcher s , institutional HREC and head of the institution.

It is important to emphasise that all consent process must be documented. In circumstances where participants are unable to provide signed consent, other alternatives such as thumb printing maybe done. Other alternative forms of documenting the informed consent process include witnessed audio recording. Research participants must be treated with respect at all times throughout the clinical trials. They must be reassured that their participation in the research although voluntary is highly valued and appreciated.

All of their concerns about their participation in the research must be attending to and as much as reasonably feasible addressed. Conduct of clinical trial is the keystone in the development of new therapies for diseases. It is also at the centre of a multi-billion dollar enterprise having pharmaceutical companies, International NGOs, clinical researchers and human research subjects as major stakeholders.

I am grateful to Professor John Ohaju-Obodo for his assistance in the conceptualisation of this manuscript. Source of Support: Nil. Conflict of Interest: None declared. National Center for Biotechnology Information , U. Journal List Niger Med J v. Niger Med J. Patrick I. While applauding the goal of the studies which, if successful, could potentially save the lives of millions of African newborns at risk of infection, the members of the group were troubled by the means to that end: placebo-controlled trials in which some mothers would be given no treatment at all.

Because studies in the US and elsewhere had already shown that a longer course of treatment with AZT was effective in cutting HIV transmission rates, they argued, it was unnecessary, and unethical, to have a control group that would go untreated.

The group had brought their concerns to the leadership of CDC; but while they had been granted a respectful hearing, they had not succeeded in altering the design of the clinical trials. Now, they faced the choice of making their objections public or acquiescing to the trials. Taking the latter course would, for them, raise the specter of complicity in the kind of research in which African Americans themselves had once been the victims, in a notorious study of syphilis.

But taking the former course would bring them into open conflict with two prominent and respected officials in CDC, themselves African American and one of them, David Satcher, head of the agency and a rising star in the Clinton administration. But the study remains controversial. For example, some patients received blood transfusions to help their immune systems; introducing new, healthy blood and immune cells could have helped these patients battle the virus better.

There were also stories of patients from the 12 centers where the study was conducted pooling their pills, to better the chances that they would get at least some of the drug rather than just placebos. And there were still plenty of questions left unanswered about the drug when it was approved. How long did the apparent benefits last? Did they benefit more than those further along in their disease? The people in the trial were already pressuring the company and the FDA to simply release the drug — if there were something that worked against HIV, they said, then it was not ethical to withhold it.

AIDS was an impending wave that was about to crash on the shores of an unsuspecting — and woefully unprepared — populace. Having at least one drug that worked, in however limited a way, was seen as progress.