Gaborone to host HIV cure study next year
Nnasaretha Kgamanyane | Tuesday December 19, 2023 09:39
While the country has done very well in exceeding two out of the three UNAIDS 90-90-90 targets and currently stands at 90-98-98, scientists are also working tirelessly to find a cure for the disease. The UNAIDS 90-90-90 targets call for 90% of people living with HIV to know their status, 90% of people living with HIV who know their status to be on Antiretroviral Therapy (ART), and 90% of people living with HIV on antiretroviral therapy to have achieved viral suppression.
Previously, the country conducted or participated in various studies most of them conducted by ACHAP, which made a huge impact in the country’s fight against HIV and AIDS over the years. Those include the HIV Diagnose and Treatment back in 2008 where research was focused on fighting Tuberculosis because at the time this was the major cause of morbidity and mortality amongst HIV positive persons.
ACHAP also conducted the Masa Programme that looked at advanced HIV/AIDS care and treatment in 2021. From that study, the government decided to provide ARV therapy to its citizens for free.
However, there were many more research studies done before and after the two mentioned and scientists through the support of different organisations such as the Botswana Harvard Health Partnership (BHP), and the National AIDS & Health Promotion Agency (NAHPA) are trying to finding scientific ways of curing HIV.
Next year, through the Botswana-Harvard AIDS Institute Partnership and different research teams in and outside the country, with the support of the Ministry of Health, three research studies will kick off with one of them starting the HIV cure trials at the beginning of next year.
Giving a research overview to different stakeholders at the Centre for Youth of Hope (CEYOHO) HIV Cure Literacy Project launch in Gaborone recently, Dr Ayotunde Omoz-Oarhe said his team will be conducting a study known as Antiretrovirals Combined with Antibodies for HIV-1 Cure In Africa (ACACIA) also referred to as the A5417 ACTG Study.
He explained that ACACIA is a randomised, double-blind, placebo-controlled study combining two long-acting broadly neutralising antibodies at ART initiation in adults living with HIV in sub-Saharan Africa. Placebo refers to a treatment that appears real, but is designed to have no therapeutic benefit.
The sites from participating African countries include centres in Gaborone, Blantyre in Malawi, Durban, Rustenburg, WITS, Soweto, eThekwini all in South Africa and Milton Park in Zimbabwe.
Omoz-Oarhe said the trials would be done in 30 People Living with HIV/AIDS (PLWHIV) in Gaborone in January next year because they need to be close by for constant monitoring.
“The trials will conducted on people aging between 18 to 60 years of age confirmed to have HIV-1, who are ART naïve meaning HIV persons who have never taken ARV treatment.
“These will be people who are willing to initiate ART at enrolment and have the ability and willingness to interrupt ART later in the study.
“If they are of childbearing age, the participants must be willing to use two effective methods of contraception until at least 12 months after antibody infusion and must be willing to use barrier protection and contraception during the time they are not taking ART.
“Participants’ HIV viral load should be undetectable after restarting ART and they must also be willing and able to provide informed consent,” he said.
Omoz-Oarhe however explained that people who have cancerous cells that have the ability to spread to other sites in the body requiring recent or anticipated chemotherapy or surgery will not be eligible for the study. Others excluded are those who had AIDS defining illnesses in the past three years, have had immune suppressive medications recently, have had severe allergic reaction in the past two years and other stipulations.
During the trials, screening visits will be conducted to assess eligibility including HIV status, medication history, physical examination, blood tests to check for liver and kidney function, hepatitis, assess immune function, sexually transmitted diseases and others..
Omoz-Oarhe added that during the study researchers will be using the Broadly Neutralising Antibodies (bNAbs) that have shown promising characteristics in pre-clinical and limited clinical studies. He also said the cure interventions needed to be tested in sub-Saharan Africa, the region most affected by the global HIV pandemic.
“The study’s primary objective is to evaluate the safety of two antibodies at ART initiation in adults living with HIV in sub-Saharan Africa,” he said.
“It is designed to evaluate the impact of combination bNAb therapy plus ART as compared to placebo plus ART on the time to sustained HIV-1 over a four week period.
“However, our secondary objective is to evaluate the time from ART discontinuation to meeting virologic, immunologic, or clinical criteria.”
Other on-going HIV Cure studies include using the Botswana adolescent demographic as an example of HIV cure research as well as the Tatelo Study. When talking about the research involving the adolescent group, Dr Catherine Koofhethile explained that this was focused on the proviral reservoir in adolescents and young adults who have been on long-term ART for over 15 years.
The study, she said, represents a significant contribution to the advancement of HIV cure research in Botswana.
“The Botswana Adolescent Cohort study offers invaluable insights into the long-term outcomes of ART initiated in early childhood.
“This report synthesizes data from studies conducted over nearly two decades to understand the dynamics of HIV persistence and the potential for HIV cure,” she said.
The Tatelo Study, meanwhile, is a pivotal clinical trial performed amongst children living with HIV in Botswana.
According to Dr Gbolahan Ajibola, the study focuses on the use of bNAbs in children recruited from the Early Infant Treatment cohort, who started ART within their first week of life.