Search / Trial NCT00001119

Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Immunity, Cellular Drug Therapy, Combination Hiv Protease Inhibitors Antibody Formation Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load Tetanus Toxoid Case Control Studies Hepatitis B Surface Antigens Acute Infection

Description

Current treatment guidelines recommend combination ART for acute primary HIV-1 infection. However, it is not known whether ART given during acute infection delays progression to AIDS or improves survival rates. Preliminary studies suggest ART given early in HIV infection not only reduces viral load but also restricts CD4+ cell loss, delays the development of opportunistic infections, and preserves T-helper cells and naive T cells. The immunologic basis of these protective effects has not been characterized thoroughly. This protocol assesses ART's effects on immune responses in early HIV inf...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients may be eligible for the main study if they:
  • Became infected with HIV within the last 120 days.
  • Are at least age 16 and have written consent of a parent or guardian if under 18.
  • Are willing to practice abstinence or use barrier methods of birth control, such as condoms.
  • Are available for at least 72 weeks.
  • Patients may be eligible for 1 of the 2 substudies if they:
  • Are at least age 16 and have written consent of a parent or guardian if under 18.
  • Have had HIV infection for more than 1 year and have a CD4 cell count greater than 500 cells/mm3, or do not have HIV infection but are at risk of getting HIV because of their lifestyle, such as sexual activity or injection drug use.
  • Have never had hepatitis B infection or a hepatitis B vaccine and they are available for 28 weeks (hepatitis B vaccine substudy only).
  • Have not received a tetanus shot in the past 5 years, have never had an allergic reaction to a tetanus shot, and are available for 8 weeks (tetanus shot substudy only).
  • Exclusion Criteria
  • Patients will not be eligible for the main study if they:
  • Have taken anti-HIV drugs for more than 7 days for the treatment of HIV. However, anti-HIV drugs taken to help prevent HIV are acceptable.
  • Have certain types of cancer.
  • Are receiving an experimental treatment.
  • Are pregnant or breast-feeding.
  • Are allergic to study drugs.
  • Have taken certain medications that may interfere with the study.
  • Patients will not be eligible for 1 of the 2 substudies if they:
  • Are receiving an experimental treatment.
  • Are pregnant or breast-feeding.

Attachments

readout_NCT00001119_2024-07-23.pdf

4.5 MB

NCT00001119_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Seattle, Washington, United States

Cincinnati, Ohio, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Pawtucket, Rhode Island, United States

San Francisco, California, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Bronx, New York, United States

Seattle, Washington, United States

Seattle, Washington, United States

Darlinghurst, , Australia

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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