New vaginal microbicide trial in the pipeline
MAKERERE University-John Hopkins University research Collaboration (MU-JHU) is preparing a vaginal microbicide trial to roll off around April. <br>A microbicide is any agent or substance which destroys a microbe (bacteria, fungi and virus). It is expected to kill HIV, stop it from entering the bloo
By Hilary Bainemigisha
MAKERERE University-John Hopkins University research Collaboration (MU-JHU) is preparing a vaginal microbicide trial to roll off around April.
A microbicide is any agent or substance which destroys a microbe (bacteria, fungi and virus). It is expected to kill HIV, stop it from entering the bloodstream or prevent it from multiplying once it enters the cell.
Vaginal microbicides are being tried to find out if they can work when applied in the vagina before sexual intercourse. These can be gels, creams, diaphragms or vaginal rings or caps, sponges, tablets and pills.
According to Dr Clemensia Nakabiito, the principal investigator, there are no effective vaginal microbicides. “There are many on trial. Some have been successful in animals and are now being tried in humans at different phases in different parts of the world.
“This trial has passed the laboratory and animal stage and has even been tried on humans in the first phase. This is phase II where we are looking at how safe it is in the human body, how easy and soon can it be processed and removed. If it passed this stage successfully, we shall take it to phase III where it will be tested on more people to see if it works,†she says.
Dr Betty Kamira, also on the same team, says the drug in the vaginal microbicide to be tested is Tenofovir, which has been successful as an ARV. This time, it will be used as a gel in the vagina to see if it can prevent HIV infection.
“An ideal vaginal microbicide has to be effective, safe, affordable, long acting, stable, accessible, acceptable by women and men and active against a wide range of microbes,†Nakabiito said. “It should also be able to maintain a normal vaginal environment and not affect pregnancy or conception.â€
This trial comes at the heels of the previous vaginal microbicide, which was stopped because the infection rate during the trial did not reduce. According to the World Health Organisation website, the trial, conducted in Uganda, Benin, Burkina Faso, India and South Africa, was trying a cellulose sulphate microbicide in the phase III study to see whether it could prevent HIV transmission in women.
Prof. Florence Mirembe, a lead investigator at the Mulago-based Microbicides Centre, says 1,333 women participated in that failed trial, but declined to reveal how many of those were Ugandans.
Currently, there are many vaginal microbicides on trial under review in more than 20 countries. These include the Carraguard study of South Africa, whose results are expected soon, PRO 2000 in Uganda, South Africa, and Tanzania which is going on until 2009.
Some trials using the BufferGel — a vaginal defence enhancer in Malawi, South Africa, Zambia and Zimbabwe will end soon this year.
Nakabiito said success in a vaginal gel will be important for women because they are more vulnerable to HIV. In Uganda six women are infected for every five men.â€
Apart from the physiological factors like the large surface area of the vagina, the prolonged contact with sexual fluids and the fact that sexually transmitted infections do not easily show,
Nakabiito said there are social factors like the inability to negotiate for safe sex, poverty and subordination, compulsory marriages, rape and defilement, dry or forced sex and genital mutilation which expose women to infection.
MU-JHU will recruit sexually active women who are HIV-negative and aged between 18-45. They must first agree with their male partners.
MAKERERE University-John Hopkins University research Collaboration (MU-JHU) is preparing a vaginal microbicide trial to roll off around April.
A microbicide is any agent or substance which destroys a microbe (bacteria, fungi and virus). It is expected to kill HIV, stop it from entering the bloodstream or prevent it from multiplying once it enters the cell.
Vaginal microbicides are being tried to find out if they can work when applied in the vagina before sexual intercourse. These can be gels, creams, diaphragms or vaginal rings or caps, sponges, tablets and pills.
According to Dr Clemensia Nakabiito, the principal investigator, there are no effective vaginal microbicides. “There are many on trial. Some have been successful in animals and are now being tried in humans at different phases in different parts of the world.
“This trial has passed the laboratory and animal stage and has even been tried on humans in the first phase. This is phase II where we are looking at how safe it is in the human body, how easy and soon can it be processed and removed. If it passed this stage successfully, we shall take it to phase III where it will be tested on more people to see if it works,†she says.
Dr Betty Kamira, also on the same team, says the drug in the vaginal microbicide to be tested is Tenofovir, which has been successful as an ARV. This time, it will be used as a gel in the vagina to see if it can prevent HIV infection.
“An ideal vaginal microbicide has to be effective, safe, affordable, long acting, stable, accessible, acceptable by women and men and active against a wide range of microbes,†Nakabiito said. “It should also be able to maintain a normal vaginal environment and not affect pregnancy or conception.â€
This trial comes at the heels of the previous vaginal microbicide, which was stopped because the infection rate during the trial did not reduce. According to the World Health Organisation website, the trial, conducted in Uganda, Benin, Burkina Faso, India and South Africa, was trying a cellulose sulphate microbicide in the phase III study to see whether it could prevent HIV transmission in women.
Prof. Florence Mirembe, a lead investigator at the Mulago-based Microbicides Centre, says 1,333 women participated in that failed trial, but declined to reveal how many of those were Ugandans.
Currently, there are many vaginal microbicides on trial under review in more than 20 countries. These include the Carraguard study of South Africa, whose results are expected soon, PRO 2000 in Uganda, South Africa, and Tanzania which is going on until 2009.
Some trials using the BufferGel — a vaginal defence enhancer in Malawi, South Africa, Zambia and Zimbabwe will end soon this year.
Nakabiito said success in a vaginal gel will be important for women because they are more vulnerable to HIV. In Uganda six women are infected for every five men.â€
Apart from the physiological factors like the large surface area of the vagina, the prolonged contact with sexual fluids and the fact that sexually transmitted infections do not easily show,
Nakabiito said there are social factors like the inability to negotiate for safe sex, poverty and subordination, compulsory marriages, rape and defilement, dry or forced sex and genital mutilation which expose women to infection.
MU-JHU will recruit sexually active women who are HIV-negative and aged between 18-45. They must first agree with their male partners.