A trial of a new HIV prevention injectable drug has resumed after the Ministry of Health and Wellness (MoH&W) decided to put the study on hold last year. This was revealed by the Botswana Harvard AIDS Institution study coordinator, Dr Emily Shava.
The HIV Prevention Trials Network (HPTN) 084, is a study being done to evaluate the safety and efficacy of the injectable agent, cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), for pre-exposure prophylaxis (PrEP) in HIV-uninfected women.
When addressing different stakeholder at the HPTN meeting at the institution at Princess Marina Referral Hospital this week, Shava said they had to put the study on hold last year after there were misunderstanding over the DTG drug used to treat HIV infection.
She said HPTN 084 study started last year but the enrolment was stopped on December. The study reactivated screen in July. “HPTN 084 is set to enrol approximately 3,200 women aged between 18 to 45 years in sub-Saharan Africa who are at risk for acquiring HIV. Here in Botswana, we are looking at enrolling 200 women. Our eligibility criteria includes HIV negative women. They must be sexually active, in good health, not planning to get pregnant during study participation, willing to provide consent and willing to complete all study procedures. This programme runs for four-and-half years,” she said.
In terms of pregnancy and contraception, Shava said from the duration of the study, participants must agree not to become pregnant. Use a reliable form of birth control, test for pregnancy at every visit and receive pregnancy prevention counselling. Participants who become pregnant on the programme will have to stop taking the randomised study product and start taking truvada and go to the clinic every 12 weeks.
The baby’s health will be checked and may be able to start study activities again when
Shava pointed out that study procedures included physical examination, discussing concerns or drug side effects, HIV/STI counselling and testing together.
She said the termination of study participation included voluntary withdrawal by participants for any reason at any time, safety concerns and if participant becomes infected with HIV during the study where follow up will continue and would be referred to the clinic for ARV initiation. If a participant does not adhere to study procedures as per agreement, her contract might be terminated. “For HIV infected participants, they will have to stop taking the randomised study product, be tested for drug resistant HIV and be referred for local care and treatment of HIV.
We so far have enrolled 13 participants and are assessing more applications to meet the targeted audience,” she said. Dr Shava further explained that the PrEP agents needed do not have to depend on daily or near-daily pill taking. She said the development of alternative agents for PrEP, and/or more adherence-friendly schedules for currently available agents, could increase prevention choices and increase acceptability. Long-acting injectable agents are said to have the potential to prevent HIV acquisition without relying on adherence to a daily oral regimen. “People do not choose which group they want to be in and neither does their doctor.
This is a randomised study where a computer is used to determine which drug to be used. This is a double-blind study. It is important for comparison to eliminate bias,” she said.