First-ever rectal microbicides study in Asia-Pacific to begin soon

Bobby Ramakant - CNS
According to Jim Pickett, Chair of International Rectal Microbicides Advocates (IRMA): Rectal microbicides are products currently under research – that could take the form of gels or lubricants – being developed and tested to reduce a person's risk of HIV or other sexually transmitted infections from anal sex. The risk of becoming infected with HIV during unprotected anal sex is 10 to 20 times greater than unprotected vaginal sex because as the rectal lining is only one-cell thick, the virus can more easily reach immune cells to infect.

HIV rates among men who have sex with men (MSM) and transgender community are alarming in the Asia-Pacific region. Unless we have safe and effective HIV prevention methods for men, women and transgender people who practice anal sex, it will be difficult to stem the epidemic. One of the most promising researches taking place on new HIV prevention technologies for MSM and transgender people is on rectal microbicides, said Dr Timothy H Holtz, Director, HIV/STD Research Programme, Thailand Ministry of Public Health (MOPH) - US Centre for Disease Control and Prevention (CDC) Collaboration, Bangkok, Thailand.

The first-ever phase-II study of a rectal microbicide in Asia-Pacific region is expected to begin soon in Thailand. This rectal microbicides study is formally called MTN017 where every study participant is going to have the same duration of exposure to all three regimens: oral Truvada/PrEP for eight weeks, rectal gel (reduced glycerin and tenofovir gel) daily for eight weeks, and sex dependent rectal gel for eight weeks. There is no placebo arm, said Dr Holtz. MTN017 study is taking place at two sites in Thailand: in Bangkok and Chiang Mai (Research Institute for Health Sciences (RIHES), Chiang Mai University). Dr Holtz is the key investigator at the Bangkok site and Dr Suwat Chariyalertsak is the key investigator at the Chiang Mai site.

“This is the first phase II rectal microbicides clinical study outside of US. We have been operating a MSM-centred clinic in downtown Bangkok for over six years now. We think it is a very MSM-friendly, warm and inviting clinic space that respects confidentiality and also provides services to those who might opt to stay anonymous” said Dr Holtz.

MSM and transgender communities in particular were involved at MTN017 study sites right from the beginning. The study is yet to begin, but community consultations were held from very early on in Bangkok and Chiang Mai to feed into the research process as it progresses ahead.

Dr Suwat informed that the Institutional Review Board (IRB) has already approved the Chiang Mai site and training by Microbicides Trials Network (MTN) was also conducted recently. Drug-under-research has also been procured. “We are just waiting for Division of AIDS approval” said Dr Suwat. 24 study participants from MSM and transgender community will be enrolled. Dr Suwat expects this MTN017 phase-II study to begin by mid-December 2013 at Chiang Mai site and will end by 2014.

Bangkok site might start this MTN017 study by January 2014. This study had to begin early but there was an added component to monitor drug levels which delayed the commencement, said Dr Holtz. “In a Pre-Exposure Prophylaxis (PrEP) study researchers had found later that participants were not taking drugs-under-research as they had reported in the study. So we wanted to get qualitative assessment to ensure that people were taking drugs under research in MTN017 study and included pharmacokinetics (PK) component to study protocol. Adherence for study products is very important. It is important to collect this data to really know whether this rectal gel works in preventing HIV transmission.”

“Thai Ethics Committee of Ministry of Public Health is very careful about study driven Investigation of New Drugs (IND) and we have answered all their concerns and are hoping to get an approval in next week or two. If we are able to get their approval we will be able to schedule the site visits from MTN to have the study training. Before that, we have to register the study protocol then only we can proceed ahead towards study initiation. Thai Drug Ministry has approved our Drug Importation Permit and Permit to import condoms and lubricants. As soon as we have our protocol registered we can start our importation process” said Dr Holtz. 18 study participants will be enrolled which may be expanded to include 24 participants in Bangkok study site.

Apart from Pittsburgh in US, Bangkok is the only other study site where ‘sigmoidoscopy’ will be performed (in which a biopsy is done to take a very small sample of rectal tissue. This sample is then taken to laboratory where in a petri-dish it is exposed to HIV and the drug under research.

Bobby Ramakant, Citizen News Service  - CNS
November 2013 

Note: This article was first published in 11th ICAAP INSIGHT, the official daily conference newspaper of 11th International Congress on AIDS in Asia and the Pacific (11th ICAAP) in Bangkok, Thailand. This newspaper was managed by Inis Communication and CNS.