We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Acute HIV Infection to Preserve Immune Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00055094
First Posted: February 20, 2003
Last Update Posted: June 24, 2005
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.
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
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
HIV Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Immune Control of HIV Replication

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 500
Study Start Date: July 1999
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria

  • Acute HIV infection
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00055094


Locations
United States, Massachusetts
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
  More Information

ClinicalTrials.gov Identifier: NCT00055094     History of Changes
Other Study ID Numbers: 1R01AI044656-01 ( U.S. NIH Grant/Contract )
5R01AI044656-04 ( U.S. NIH Grant/Contract )
First Submitted: February 19, 2003
First Posted: February 20, 2003
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:
Infection
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