Results on HIV study expected next year

Barely a fortnight after the University of Zimbabwe-University of California San Francisco Collaborative Research Programme (UZ-UCSF), announced progress in its preparations to host the country’s first ever HIV vaccine clinical trial in Seke, the association has made another announcement that a related study has already been completed with results expected in December this year.

UZ-UCSF told The Sunday Mail Extra a couple of weeks ago that a HIV vaccine clinical trial is set to begin in the country in December under the code name HVTN 107.

In addition to that, the collaboration has made another announcement that it is expecting results of a related research called “A Study to Prevent Infection with a Ring for Extended Use (Aspire)” which has already been running since 2012.

While not a HIV vaccine clinical trial in the sense of HVTN 107, Aspire is a study that seeks to determine whether a woman’s use of a vaginal ring containing the anti-retroviral (ARV) drug (dapivirine) is a safe and effective method to prevent HIV infection.

According to UZ-UCSF the ring which is inserted into a woman’s vagina secretes anti-retroviral compounds which are believed to have the power to prevent HIV infection.

The study enrolled over 600 women in Seke South, Zengeza and Spilhaus, and has been touted as a success.

While the development is another positive step in the fight against HIV/Aids, UZ-UCSF researcher, Dr Nyaradzo Mugodi, said the results will not be conclusive as they are only a stage of drug formulation meaning the fruits, if there are any, will only be enjoyed much later.

Dr Mugodi said other studies of the same drug combination in the form of an injection and tablets are underway with results expected later in 2016.

“Let me take this opportunity to share with you the other study that we are conducting at Seke South, Zengeza and Spilhaus,” said Dr Mugodi at a HIV vaccine research dialogue in Harare last week.

“In this study we were looking at the possibility of preventing HIV infections with a ring known as the vaginal ring containing an anti-retroviral drug called dapivirine.

“Women came to the clinic every month and we gave them the dapivirine ring, they inserted it and now we have finished the study we started it in 2012.

“We are analysing the results and in December or early January we are going to have the results for you to see if it works to prevent HIV.”

Dr Mugodi said if Aspire is found to be working it will go to the final stage where its uptake will be evaluated.

“If it is found to be working we are not going to dish out the drug to women to protect themselves, we are still going on to proceed to what we call the open label phase to see if women are using it in their homes.

“In a nutshell our results are going to be available in December or January and we will be calling you to share the results with you.”

Dr Mugodi said most of the studies are targeting women at the moment as they are the most affected by HIV/Aids.

She went further to unpack vaccine research protocols dismissing claims that people are injected with the HIV virus during studies.

“Whenever we do research we are concerned about the wellbeing of people. So we don’t just start,” she said.

“We have got several phases of clinical trial. Whenever we have a potential candidate, whether as preventive or treatment, we start in the lab, to say if I use this compound on cells what is going to happen, we call that pre-clinical or laboratory trials.

“If on that potential candidate is working, we now move on to lab animals, for example the guinea pigs, rats, rabbits and other small mammals which we use in the lab. We then move on to other animals which resemble human beings, the chimpanzees, gorillas, baboons, monkeys and so forth.”

Dr Mugodi said once the vaccine compounds are deemed safe and effective in these animals they are tested on people, starting with small numbers to ensure public safety.

“We don’t just start by giving it to many people, we start with a small number of healthy people to see if it is safe.”

The health expert said should the vaccine pass all these phases it is presented to Government for approval before being given to the people.

Health and Childcare Minister, Dr David Parirenyatwa, hailed the studies saying any research aimed at eradicating HIV/Aids is welcome.

“Our position as a ministry is that any research which seeks to arrest the scourge of HIV/Aids is a welcome one,” he said.

“However, we obviously want due processes to be followed to ensure that public health is maintained. The regulatory boards are the ones responsible with ensuring that everything is done according to procedure.”

Nonetheless, going into the society to convince people to enroll in a voluntary clinical trial is not an easy task, particularly when dealing with HIV issues.

To make that work possible and easy, community engagement co-ordinator, Mr Charles Chasakara, said it is imperative to build a transparent relationship with communities.

“Researchers are there, interventions are there but without people, without communities you cannot do any research,” he said.

“So our job as community engagement staff is to prepare the community and to asses them, we want to prepare the community to accept research but most importantly we want them to understand and appreciate why we are conducting clinical trials.

“So what we do before we implement a clinical trial is that we go into the community to do some community mapping to identify communities’ stakeholders and identify the kind of people we are looking to work with.

“What has helped us greatly is that we work with community advisory boards, what the community advisory boards do is that they link us with the community, they link us with stakeholders in the community for us to do awareness campaigns, education sessions and sensitisation meetings.

“So when we identify a catchment area for our recruitment, we engage these guys in recruitment planning and education programmes and after we have done that we go into the communities to find volunteers.”

A community advisor, Mr Stanford Chimutimunzeve, said their work is to make sure that ethics are upheld during the research so that participants are not abused.

“As a community advisory board, we look to see if the investigators are following the code of ethics in clinical research so that participants don’t end up being abused.

“We also work closely with these guys to make sure that there are no myths and misconceptions in research, we mobilise the communities to make sure that they share the correct and accurate information about the research.”

Other countries in the West have already made strides in coming up with HIV prevention drugs.

A daily pill called Truvada is already widely used in the US after it was approved by the US Food and Drug Administration in 2012 as the first daily pill to help prevent HIV in some high-risk groups.

It is available through most private health insurance plans in the US and the state Medicaid system.

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