A randomized trial of highly active antiretroviral therapy in acute/early HIV infection
About the study
The purpose of this study is to evaluate the effectiveness of an experimental strategy for treating HIV. The study aims to determine whether one year of highly active antiretroviral therapy (HAART) slows the progression of HIV disease in adults who have been recently infected with HIV.
Each participant will be randomly assigned to one of two study groups. Those assigned to the Treatment group will start taking anti-HIV medications right away and continue to do so for one year. Those assigned to the Wait group will only start taking anti-HIV medications if their immune system is not functioning well and they meet the standard of care guidelines for treating HIV.
The study will evaluate the effectiveness of the immediate treatment strategy by comparing the viral load and CD4 cell counts of treated versus untreated study participants at two and three years following study entry. Within the Treatment group, the study will also compare the viral load and CD4 counts of participants who enrolled within 3 months of being infected with HIV (called “acute seroconverters”) versus participants who enrolled between 3 to 12 months after initial HIV infection (called “early seroconverters”). In addition, the study will evaluate the toxicity of HAART in all treated participants.
This study is sponsored by the U.S. National Institutes of Health and has a target enrolment of 180. In Canada, the study is hoping to recruit 132 participants from four Canadian sites.
About the disease/condition
Once HIV enters the body, the virus infects a large number of CD4+ T cells and replicates rapidly. During this acute (also called “primary”) phase of infection, the blood contains many viral particles that spread throughout the body, seeding themselves in various organs, particularly the lymphoid tissues. Acute HIV infection often passes unrecognized, but may be present as a flu-like syndrome, especially in the weeks following infection. Usually, HIV infection is diagnosed using a test for HIV antibodies, but the diagnosis of acute infection is made by demonstrating the presence of the virus itself in the blood, often before any antibodies are present.
This study examines HIV treatment strategies—not a particular drug or combination of drugs. At the present time, the standard of care guidelines for treating HIV advise that treatment should be started when a person’s CD4 cell count falls to between 200 and 350 cells/mm3. This strategy developed over time, as researchers realized that treatment was not able to eliminate the HIV virus from the body, and studies demonstrated that the effect of therapy is the same at different CD4 levels, except when CD4s fall below 350 and especially below 200 cells/mm3. Since HIV therapy often has side effects, triggers the development of drug-resistant HIV, involves complicated drug regimens and is expensive, it is therefore delayed as long as possible.
The aim of the immediate treatment strategy proposed in this study is to delay even further the need to start HIV therapy in the long run. By hitting the virus with a course of HAART very early in its invasion of the body, the researchers are looking into keeping the immune system relatively healthy for longer (i.e., keeping the CD4 cell count up) and slowing the progression of HIV.
It is not known which strategy works better. The aim of this clinical trial is to help address this research question by evaluating the effects of the immediate treatment strategy on the immune system and viral levels at two and three years after the start of treatment.
The study does not limit the types or number of anti-HIV drugs that a participant can take. A participant’s physician can prescribe any anti-HIV medications that he/she deems appropriate. However, a participant’s study group assignment will determine when the participant will start anti-HIV medications.