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Treatment of Acute HIV Infection to Preserve Immune Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055094
Recruitment Status : Completed
First Posted : February 20, 2003
Last Update Posted : June 24, 2005
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

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
HIV Infections

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 Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Immune Control of HIV Replication
Study Start Date : July 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Acute HIV infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00055094

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02116
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Bruce Walker, MD Massachusetts General Hospital Identifier: NCT00055094     History of Changes
Other Study ID Numbers: 1R01AI044656-01 ( U.S. NIH Grant/Contract )
5R01AI044656-04 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2004

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Immune system
Helper T-Cells
Acute Infection
Treatment naive

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases