Search / Trial NCT00000893

Safety, Tolerability, and Anti-HIV Activity of DMP 266 (Efavirenz) in Combination With Nelfinavir in HIV-Positive Children

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

Dose Response Relationship, Drug Drug Therapy, Combination Hiv Protease Inhibitors Nelfinavir Reverse Transcriptase Inhibitors Area Under Curve Efavirenz

Description

The demonstrated antiviral activity, tolerability, and pharmacokinetic properties of DMP 266 and its utility in combination with other agents make DMP 266 an attractive agent for use in HIV-infected pediatric patients. However, the tolerability of DMP 266 in the pediatric population must be evaluated, and appropriate dosing instructions need to be developed. By following the patients over time, the antiviral activity of DMP 266-containing regimens will be documented. Dosage guidelines for children can then be developed following analysis of the results. This is a 48-week [AS PER AMENDMENT ...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Children may be eligible for this study if they:
  • Are HIV-positive.
  • Are between 3 months and 16 years old (consent of parent or legal guardian required). (These age requirements reflect a change.)
  • Have a plasma viral load of at least 400 copies/ml at screening.
  • Agree to practice abstinence or use effective methods of birth control during the study.
  • Are able to take oral medication and comply with study requirements.
  • Are taking at least 1 nucleoside reverse transcriptase inhibitor (NRTI), such as zidovudine (ZDV) or stavudine (d4T). Patients can begin taking NRTIs at the beginning of the study.
  • Exclusion Criteria
  • Children will not be eligible for this study if they:
  • Have had more than 2 episodes of moderate to severe diarrhea or vomiting lasting more than 4 days within 3 months prior to study entry.
  • Are allergic to EFZ or NFV.
  • Have any disease, including hepatitis, cancer, or an active opportunistic (HIV-associated) infection.
  • Are pregnant or breast-feeding.
  • Are taking any other experimental drugs or certain medications.
  • Have ever taken protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs).

Attachments

readout_NCT00000893_2024-07-23.pdf

4.5 MB

NCT00000893_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

Oakland, California, United States

San Diego, California, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

New York, New York, United States

Los Angeles, California, United States

Baltimore, Maryland, United States

Worcester, Massachusetts, United States

Bronx, New York, United States

Brooklyn, New York, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Houston, Texas, United States

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Long Beach, California, United States

Los Angeles, California, United States

Torrance, California, United States

Washington, District Of Columbia, United States

Jacksonville, Florida, United States

Philadelphia, Pennsylvania, United States

Memphis, Tennessee, United States

Seattle, Washington, United States

New York, New York, United States

New York, New York, United States

Seattle, Washington, United States

Jackson, Mississippi, 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

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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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