Treatment of Acute HIV Infection to Preserve Immune Function

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00055094
Collaborator
(none)
500
1

Study Details

Study Description

Brief Summary

While most people with HIV experience significant destruction of their immune systems, some people appear to have preserved immune function and can control the virus without drugs. Early treatment with anti-HIV drugs may help preserve the immune system, allowing it to control the virus once the drugs are stopped. This study will evaluate the immune system response of HIV infected people who are treated with anti-HIV drugs soon after being infected.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Studies have identified a potent CD4 T helper (Th) cell response in some infected people, and have shown a correlation between virus-specific Th cells and low levels of viremia. Early institution of potent antiviral therapy in the earliest stages of acute HIV infection have led to strong Th cell responses, analogous to those seen in people who are able to control viremia in the absence of antiviral therapy. This may be because potent antiviral therapy is able to protect virus-specific Th cells as they become activated, and thus these cells are not lost in the earliest stages of infection. This study will characterize the immune response of patients with acute HIV infection who receive antiretroviral therapy and will determine the effects of interruption of therapy in those people who have immune responses to HIV that are similar to patients with long-term non-progressing infection.

    Participants in this study will be followed through June 2004. Study visits vary from only once to every month and are scheduled at the discretion of the study officials. Study visits include an interview and blood tests.

    Study Design

    Study Type:
    Observational
    Observational Model:
    Defined Population
    Time Perspective:
    Prospective
    Official Title:
    Immune Control of HIV Replication
    Study Start Date :
    Jul 1, 1999

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

      Inclusion Criteria

      • Acute HIV infection

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Massachusetts General Hospital Boston Massachusetts United States 02116

      Sponsors and Collaborators

      • National Institute of Allergy and Infectious Diseases (NIAID)

      Investigators

      • Principal Investigator: Bruce Walker, MD, Massachusetts General Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00055094
      Other Study ID Numbers:
      • 1R01AI044656-01
      • 5R01AI044656-04
      First Posted:
      Feb 20, 2003
      Last Update Posted:
      Jun 24, 2005
      Last Verified:
      Apr 1, 2004

      Study Results

      No Results Posted as of Jun 24, 2005