Search / Trial NCT00001118

Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children

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

Apply for Trial

Trial Information

Current as of June 13, 2024

Completed

Keywords

Injections, Intravenous Injections, Subcutaneous Drug Therapy, Combination Hiv Protease Inhibitors Membrane Fusion Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load Peptide T20

Description

T-20 is the first drug to be developed which specifically inhibits the function of the gp41 transmembrane glycoprotein. By inhibiting the essential protein-protein surface interaction, T-20 is able to block the process of virus-to-host cell membrane fusion. Combination antiretroviral regimens (reverse transcriptase inhibitors plus PIs) have benefited many HIV patients, but heavily pretreated patients often develop multi-drug resistance via multiple gene mutations. A pharmacologic agent, such as T-20, that is effective at an alternative point in the virus replication cycle will make a valuab...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Children may be eligible for this study if they:
  • Are 3 to 12 years old (consent of parent or guardian required).
  • Are HIV-positive.
  • Are receiving combination anti-HIV therapy. He/she must have been taking this combination for at least 16 weeks, and it must include either 2 NRTIs alone or 2 NRTIs plus either an NNRTI or a PI. (This study has been changed. This no longer has to be a child's first anti-HIV drug combination.)
  • Have a viral load greater than 10,000 copies/ml while taking this anti-HIV drug combination.
  • Have never received treatment with a PI or an NNRTI. (One or two doses are allowed.)
  • Have never taken at least 1 NRTI.
  • Exclusion Criteria
  • Children will not be eligible for this study if they:
  • Are receiving treatment for an opportunistic (AIDS-related) or serious bacterial infection at the time of study entry.
  • Are receiving chemotherapy for cancer.
  • Have certain serious diseases (other than HIV) or conditions.
  • Have received or are currently receiving certain medications.
  • Are pregnant.

Attachments

readout_NCT00001118_2024-06-13.pdf

4.5 MB

NCT00001118_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

Springfield, Massachusetts, United States

Bronx, New York, United States

La Jolla, California, United States

Long Beach, California, United States

San Francisco, California, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

Great Neck, 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

Charleston, South Carolina, United States

San Juan, , Puerto Rico

Newark, New Jersey, United States

Bronx, New York, United States

Los Angeles, California, United States

New Orleans, Louisiana, United States

Worcester, Massachusetts, United States

Jacksonville, Florida, 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
0
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?

Discussion 0