Search / Trial NCT00001097

Long-Term Effects of HAART in Youth With Stronger Immune Systems Versus Youth With Weaker Immune Systems

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

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Trial Information

Current as of May 26, 2024

Completed

Keywords

Drug Therapy, Combination Hiv Protease Inhibitors Reverse Transcriptase Inhibitors Anti Hiv Agents

Description

Recent adult clinical trials involving combination HAART, including a protease inhibitor (PI), have demonstrated improvements in somatic immune system functioning. [AS PER AMENDMENT 2/27/01: More recently, similar success has been demonstrated with a PI-sparing regimen, zidovudine, lamivudine, and efavirenz.] Not all individuals, however, experience the same level of immune reconstitution, and oftentimes any improvement is short-lived. Adolescent patients may have a greater potential for immune restoration because of residual thymic tissue and therefore may experience greater long-term viru...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Children may be eligible for this study if they:
  • Are HIV-positive.
  • Are between 8 and 22 years old (consent of parent or guardian required if under 18).
  • Have detectable levels of HIV in the blood within 30 days prior to study entry.
  • Expect to be on the study for at least 1 year. (This study has been changed by adding this requirement.)
  • Are pregnant and are not taking didanosine/stavudine (ddI/d4T) or EFV as part of their HAART regimen. (This study has been changed so that pregnant patients may be eligible if they are not taking ddI/d4T or EFV.)
  • Exclusion Criteria
  • Children will not be eligible for this study if they:
  • Are taking HAART or more than 1 anti-HIV drug.
  • Were infected with HIV before birth, at the time of delivery, or by a blood transfusion during birth.
  • Have taken part in the study before.
  • Have not responded well to HAART in the past.
  • Have taken drugs to boost the immune system such as HIV vaccines, IVIG, or cytokine therapy.
  • Have AIDS-related (opportunistic) infection at the time of screening. (This study has been changed so that patients with an AIDS-related infection are ineligible.)
  • Are pregnant and are taking ddI/d4T or EFV as part of their HAART regimen. (This study has been changed so that pregnant patients are ineligible if they are taking ddI/d4T or EFV.)

Attachments

readout_NCT00001097_2024-05-26.pdf

4.5 MB

NCT00001097_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

Los Angeles, California, United States

Springfield, Massachusetts, United States

Seattle, Washington, United States

Bronx, New York, United States

La Jolla, California, United States

Los Angeles, California, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Brooklyn, New York, United States

Great Neck, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Syracuse, New York, United States

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Bronx, New York, United States

Los Angeles, California, United States

Jacksonville, Florida, United States

Birmingham, Alabama, United States

Mobile, Alabama, United States

Farmington, Connecticut, United States

Fort Lauderdale, Florida, United States

Gainesville, Florida, United States

Riviera Beach, Florida, United States

New Orleans, Louisiana, United States

Jackson, Mississippi, United States

Norfolk, Virginia, United States

Phoenix, Arizona, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

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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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