Study Highlights Importance of Starting Antiretroviral Therapy Early
A clinical trial has shown that better results are achieved in HIV-infected adults by starting antiretroviral therapy (ART) sooner than recommended by the World Health Organization.
The study is called CIPRA HT 001. It was conducted in Haiti by the National Institute of Allergy and Infectious Diseases (NIAID), which is a part of the National Institutes of Health (NIH). The study was conducted from 2005 to 2009.
CIPRA HT 001 study:
The study was conducted taking the CD4+ T cell count into account. CD4+ T cell count tells us about the strength of the immune system. The more the CD4+ T cell count in the blood, the stronger the immune system is. WHO guidelines indicate that a HIV-infected person should be given antiretroviral therapy (ART) after his/her CD4+ T cell count drops below 200 cells/mm3.
The trial enrolled 816 HIV-infected adults aging 18 and above. All these people were in the early stages of the infection, and their CD4+ T call counts were between 200 and 350 cells/mm3. Half the patients were selected at random to be given antiretroviral therapy in two weeks. The other half were given antiretroviral therapy after their CD4+ T cell count fell below 200 cells/mm3.
The trial was monitored every year by a Data and Safety Monitoring Board (DSMB). The DSMB consists of independent experts who analyze the results of the study until that point of time. Based on the analysis, they decide whether the trial is safe for the participants, whether the objectives are being achieved etc.
In May 2009, the DSMB analyzed the data and found overwhelming evidence in favor of starting antiretroviral therapy (ART) early. They found that only six people in the early treatment group had died, while the number was 23 for the late treatment group. Also, among participants who did not start with tuberculosis (TB), only 18 contacted TB in the early treatment group while 36 people contacted TB in the late treatment group.
So, the DSMB ordered the trial to be stopped as the objective has been achieved. They directed the study team to give ART to all the participants regardless of CD4+ T count.
Impact of the study:
- The study was ended early so that the findings can be shared by other countries and organizations working on HIV. This valuable information will help health workers understand the needs of HIV patients better.
- Earlier, as only patients under the recommended CD4+ T count were given ART, the demand for medication could be met up to 30% in middle and low income nations. Now that every HIV patient can be given ART, it will put pressure on the global community to supply medication to all who need it.
- The findings will persuade health workers to identify HIV-infected people in the early stages, so that they have a better chance of living.