Immune Control of HIV-1 Study, Partners AIDS Research Center
( — Backgrounder created October 20, 1998 — )

This study is being conducted in the Partners AIDS Research Center at the Massachusetts General Hospital (MGH) and is based on a scientific discovery reported in the November 21, 1997, issue of Science (see news release). That study reported that antiviral treatment of persons with acute HIV-1 infection – the flu-like symptoms that appear in the first weeks following infection – leads to the generation of a type of immune response similar to that seen in long-term nonprogressors, persons who are able to control the virus in the absence of antiviral therapy and remain healthy for several years despite being infected with HIV.

Since this initial report, the MGH team has identified about 20 individuals who had recently been infected with HIV, started them on immediate antiviral drug treatment and observed a similar immune response when the virus was held in check by the drugs. The current trial is designed to see whether this apparent duplication of the immune response seen in long-term nonprogressors can control the virus without continuing treatment with antivirals, which are expensive and have potentially serious side effects.

The trial is open only to individuals infected with HIV who were started on antiviral therapy at the earliest stage of infection (before antibodies could be detected in their blood), who have had undetectable blood levels of virus for eight months or more and – most importantly – who have strong, HIV-specific immune responses from both helper T cells and killer T cells. The trial is not appropriate for those who started antiviral therapy at later stages after their initial infection and do not exhibit the HIV-specific T-cell responses seen in long-term nonprogressors.

Participants will stop all antiviral therapy and be closely monitored for an increase in blood levels of HIV using the most sensitive technology available. If virus levels do rise, antiviral drug treatment will be reinstated, and researchers will determine whether reinstatement results in a boost in the immune response. Based on recent research findings, the research team believes that any resurgent virus in this select group of patients would not be resistant to current antiviral drugs and should respond to reinstitution of therapy. It should be stressed that the study is only being performed on persons treated in the earliest stages of infection.

As with all research studies involving human participants, this study has been reviewed and approved by hospital's Institutional Review Board, which is charged with ensuring that all research protocols are scientifically appropriate and that participants are fully informed of any risks. The IRB agreed with the research team that the risks involved in the study are small in this particular group of persons. Those risks include the possibility of increased HIV replication, emergence of drug-resistant strains of HIV, the potential for the virus to invade currently uninfected areas of the body, recurrence of symptoms related to acute HIV infection, and the anxiety that may accompany discontinuing drug treatment.

While the study is ongoing the scientists will not be able to comment on the study. Results related to this study will be presented when the experiments are completed. The study is anticipated to last approximately one year.

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