Kampala. The Joint Clinical Research Centre (JCRC) has begun clinical trials of injectable ARVs in three research centres across the country.
The drugs dubbed ‘COBOTEGRAVIR (CAB)’ and ‘RILPIVIRINE (RPV)’ will undergo an efficacy and safety (CARE) study.
While launching the trials in Kampala yesterday, Dr Cissy Kityo, the executive director of JCRC, said they have decided to carry out a 24-months trial in sub-Saharan Africa to ensure that the drugs work effectively.
“The overall aim of this study is to determine that switching from taking daily anti-retroviral treatment (ART) pills to injectable long acting RPV plus CAB will reduce the effectiveness of the ART on the participants,” she said.
Dr Kityo added that this will mean that the viral control will be maintained and the side effects reduced and the general livelihood of the patient will not be affected.
‘The trials will target 512 participants that are already stable on their ART and they will be enroled in this study to continue taking ART or switch to the long-acting RPV plus long-acting CAB for the treatment period of two years,” she said.
Dr Kityo added that participants will be recruited across eight sites from three countries. These include Uganda with JCRC Kampala, JCRC Fort Portal, and Infectious Disease Institute (IDI); Kenya with KEMRI, AMPATH and Aga Khan Hospital, and South Africa with Ezintsha and SAMRC.
“Adults of 18 years and above are the only participants who qualify to take part in these trials. They must be healthy with a suppressed viral load,” she said.
Dr Kityo added that doctors will take participants for check-up for any presence of any diseases that bar them from joining the trials.
“All participants should be able to attend all the 12 visits when they are on trials and women should not be breast feeding or pregnant, they should be willing to use contraception. Participants are not allowed to take existing ARV pills during the trial,” she said.
Dr William Tamale, the JCRC clinial manager, said participants will be given an option of starting with the oral form of RPV and CAB to see if they can take them well or to go straight to injections.
After stabilising on injections, they will be returning for repeat injections every two months up to 24 months.
“After the injections, we will monitor the participants’ viral loads every after six months to determine if they are responding well to treatment,’ he said.
Dr Tamale added that they will keep monitoring for side effects to check if the drugs are safe, including quality of life assessments, satisfaction with treatment and also make economic evaluations.
“We shall also observe if people come for their injections every after two months because it is like taking the pills, and if you miss several days, there is a risk of developing resistance to those drugs,” he said.
The researchers say the drugs will be another option for people with HIV, especially those who find it a challenge to take the tablets.
They expect this to increase adherence to treatment because it overcomes the challenges of forgetting to take drugs. According to researchers, patients get drug fatigue.
It will also overcome the stigma, especially when they are in public which is not aware about their status.
The researchers hope that after some time, the injectable can be taken longer than four months.
Participants are supposed to take a pill once a day, and after one month, they will come back for the injection.Patients will be kept for 30 minutes to monitor them so that they do not get any side effect.
When they go home, they have to contact the experts if there is any issue. The researchers will record the safety and any other side effect that may arise from the drug.