148 ESWATINI WOMEN TO UNDERGO HIV VACCINE TRIAL

MBABANE – A total of 148 emaSwati women will be put on the long-acting injectable cabotegravir for pre-exposure prophylaxis (PrEP).
The long-acting injectable cabotegravir offers prevention against HIV and AIDS.

Eswatini is expected to be part of the clinical trials of the HPTN 084, a multi-country, multi-site randomised controlled superiority clinical trial exploring the safety and efficacy of the long-acting injectable cabotegravir.
This would be compared to daily oral tenofovir, dispoproxil fumarate/emtricitabine for PrEP in HIV-uninfected women.
 This is a worldwide collaborative clinical trial network that brings together investigators, communities and other partners to develop and test the drug.
Other participating countries in the clinical trials include South Africa, Kenya, Malawi, Uganda, Botswana and Zimbabwe. 

People taking the injection are expected to receive 800mg every eight weeks. Cabotegravir (abbreviated as CAB LA) falls under the class of anti-retroviral medicines called integrase inhibitors.
Clinical trials of the HIV injection are expected to begin by the end of August and will target HIV-uninfected women.
This is according to the Head of Research at the Ministry of Health Zandi Mnisi, who said they were expecting to recruit women aged 18 to 45 years old.
Mnisi said agencies involved in the trial included the Ministry of Health, ICAP Swaziland and the Family Life Association of Swaziland.
The project is funded by the National Institute of Health in the United States.

Mnisi said the enrolment would last for 12 months and this would be followed by a follow-up period of four and a half years.
She said they already had a pharmacy, laboratory and refrigerators and were awaiting independent assessors from outside the country to visit the site and determine whether it met the required standards.
According to Mnisi, locally the Medicines Regulatory Authority is expected to visit the site for the second time. “The first time they came to check on the site they advised us to fix a few things otherwise they said we were on the right track.” 
She said due to the fact that it was an investigational drug which was not approved by SBA, anything could happen during the trials. “We want to have a room where we would be able to resuscitate participants and we have a contract with EPR and Mbabane Clinic who would be responsible when complications are experienced,” she said.
However, she said the blood samples during the trials would be analysed by BARC Laboratories in South Africa, while others would be conducted locally at the Mbabane Government Hospital laboratory.
She said the intention was that one laboratory is used by all the countries that would take part in order to get satisfactory results.
Further, Mnisi said the overall study period would be approximately over four and a half years, with individual participants being followed on randomised study product between one and a half years (for the last enrolling participants) to approximately 3.6 years (for the earliest enrolling participants), after an accrual period of approximately two years.  

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