The only remaining hope in microbicide research

The only remaining hope in microbicide researchResults of the Carraguard clinical trial - the first microbicide candidate to complete a Phase 111 trial '€“ are expected to be released in a few weeks'€™ time.

Results of the Carraguard clinical trial – the first microbicide candidate to complete a Phase 111 trial ‘€“ are expected to be released in a few weeks’€™ time.

Read More

The audio is in isiZulu. See the English summary below.

MABUTHO: ICarraguard, okuwuketshezi olufakwa esithweni sangasese kumuntu wesifazane oluhlolelwa ukuvikela igciwane le HIV, iqale ukuhlolwa kuleli ngo 2004. Zintathu izikhungo lapho ibihlolwa khona  phakathi kwazo okubalwa iCape Town, eThekwini kanye nase Soshanguve ngaphandle kwase Pitoli. Ukuhlolwa kwalelikhambi kusesigabeni esibizwa ngo Phase 111 nokuyisigaba sokugcina sokuhlolwa kwekhambi. Sixoxisane no Dr Khatidja Ahmed ophethe esinye sezikhungo ezengamele ukuhlolwa kwakelikhambi esiseSoshanguve. UDr Ahmed uthi lelikhambi ilona lodwa kuloluhlobo lwamakhambi (microbicides) ahlolelwa ukuvikela igciwane le HIV elikwazile ukufinyelela esigabeni sokugcina, uPhase 111, njengoba amanye abehlolwa aye amiswa ngezizathu ezahlukene ezibandakanywa nokungaphephi kwawo.

DR KHATIDJA AHMED: At this moment, Carraguard is the only study that has completed Phase 111. There were other studies in the pipeline but they have been stopped by the Safety and Monitoring Board ‘€“ which is an independent board that does analysis of the data during the course of the study. Some studies have been stopped for safety concerns and some for other reasons. So this is the first one to have reached the completion.

MABUTHO: UDr Ahmed uthi nakuba kubaphathe kabi ukungaphumeleli kwamanye amakhambi abehlolelwa ukuvikela igciwane le HIV kodwa uthi okungenani kukhulu abakufundile ngawo nokuzosiza ekwengezeni ulwazi lwabo ngokuhlolwa kwamakhambi.

DR KHATIDJA AHMED: Although the results have been disappointing, they are not negative in the sense that we have learnt lessons from the studies’€¦ in terms of safety of the product and how to conduct the trials, what is required now to improve on how the way we conduct trials. So it’€™s a stepping-stone to more and better products that can be developed.

MABUTHO: Kodwa okudida abaningi ngamakhambi ahlolelwa ukuvikela igciwane le HIV ukuthi labo ahlolwa kubona bayaye batshelwe ukuba basebenzise ama khondomu ukuzivikela kwigciwane le HIV. Lokhu kushiya umbuzo wokuthi pho kuthiwa mabasebenzise ama khondomu ukuzivikela kwigciwane le HIV, kuzotholakala kanjani ukuthi ikhambi elihlolwayo liyasebenza? UThandi Moloi ungomunye wabebeyingxenye yokuhlolwa kwalelikhambi naye ozithola enalombuzo ongaphenduleki.

THANDI MOLOI: My problem is I don’€™t know if it’€™s going to work because we are using condoms. So, how are we going to know if this gel is working because we are using protection? So, it’€™s difficult for me to understand.

MABUTHO: Kepha uDr Ahmed uyachaza ukuthi yingani begqugquzela bonke labo lelikhambi elihlolwa kubona ukuba basebenzise ama khondomu.

DR KHATIDJA AHMED: We know from all the data that we capture throughout the study from these participants that not everybody uses condoms every time and each time they have sex. ‘€¦It’€™s not always in the control of the female to use condoms. So having captured that data, that data is taken into the analysis of the product data. ‘€¦So, based on the statistics then we can determine if the product works or not.

MABUTHO: UDr Ahmed uthi uma kungukuthi lelikhambi, iCarraguard liba impumelelo kuyofana nokuthi bashaye izinyoni ezimbili ngetshe elilodwa. Uthi ukusho lokhu ngoba bakwazile ukufundisa abesifazane abaningi lelikhambi ebelihlolwa kubona ngezifo zocansi kanjalo nangegciwane le HIV.

DR KHATIDJA AHMED: The most important thing is that we have educated such a large number of women in the community’€¦ We’€™ve educated them on research, we’€™ve educated them on sexual behaviour, we’€™ve educated them on HIV, we’€™ve educated them on other sexually transmitted infections. ‘€¦Our biggest achievement in this is the number of women that have been educated through this trial and, of course, if the product proves to work, then we have gained even more.

MABUTHO: Uma imiphumela yalelikhambi, okulindeleke ukuba ikhishwe emavikini ambalwa, ikhombisa ukuba impumelelo lokho kuyosho lukhulu kwabesifazane. Lokhu kungenxa yokuthi izikhathi eziningi abesifazane banenkinga yokuncenga abesilisa ukuba basebenzise amakhondomu ukuvikela ukuthola igciwane le HIV.

The English summary.

The only remaining hope in microbicide research

Results of the Carraguard clinical trial – the first microbicide candidate to complete a Phase 111 trial ‘€“ are expected to be released in a few weeks’€™ time.

Carraguard, a gel made for vaginal use with the hope of reducing HIV infection in women, has successfully completed all phases of research. The product was tested on women in three different research sites ‘€“ Cape Town, Durban and Soshanguve, near Pretoria and research was completed in June. It’€™s encouraging to note that this is the only microbicide trial to have run its course without being stopped, enthused Dr Khatidja Ahmed, the Principal Investigator in the Soshanguve study.

‘€œAt this moment, Carraguard is the only study that has completed Phase 111. There were other studies in the pipeline, but they have been stopped by the Safety and Monitoring Board ‘€“ which is an independent board that does analysis of the data during the course of the study. Some studies have been stopped for safety concerns and some for other reasons. So, this is the first one to have reached the completion,’€ said Dr Ahmed.

Participants in the trial were followed up for up to two years. This was a double-blinded study and the women were divided into two groups. One was required to use either the active gel, Carraguard or a placebo. They had to apply it inside the vagina before every sexual activity. But even if they used the gels, all participants were told to use condoms during sex. This has made some of the participants question as to how researchers will know if the product works or not, when they say condoms must be used at all times. Thandi Moloi is one of such participants.

‘€œMy problem is I don’€™t know if it’€™s going to work because we are using condoms. So, how are we going to know if this gel is working because we are using protection? So, it’€™s difficult for me to understand,’€ said Moloi.

Dr Ahmed understands concern and tries to make sense of the advice the study team offers participants.

‘€œWe know from all the data that we capture throughout the study from these participants that not everybody uses condoms every time and each time they have sex. ‘€¦It’€™s not always in the control of the female to use condoms. So, having captured that data, that data is taken into the analysis of the product data. ‘€¦So, based on the statistics then we can determine if the product works or not,’€ said Dr Ahmed.

Ahmed is happy that the study has successfully run its course and the team is now anxiously awaiting the results. She says even if the results do not show that Carraguard is effective in preventing HIV in women, there is much that they would have achieved with the study.

‘€œThe most important thing is that we have educated such a large number of women in the community’€¦ We’€™ve educated them on research, we’€™ve educated them on sexual behaviour, we’€™ve educated them on HIV, we’€™ve educated them on other sexually transmitted infections. ‘€¦Our biggest achievement in this is the number of women that have been educated through this trial and, of course, if the product proves to work, then we have gained even more,’€ she said.