Search / Trial NCT00000901

Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children

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

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Dose Response Relationship, Drug Drug Therapy, Combination Stavudine Hiv Protease Inhibitors Lamivudine Indinavir Rna, Viral Reverse Transcriptase Inhibitors Viral Load

Description

In this multicenter, open-label study patients receive a combined drug regimen of indinavir, stavudine, and lamivudine over 48 weeks. Patients are evaluated at Weeks 0, 2, 4, every 4 weeks until Week 24, and every 8 weeks thereafter until study completion. [AS PER AMENDMENT 4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.]

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Your child may be eligible for this study if he/she:
  • Is 3 - 15 years old and has consent of a parent or legal guardian who is able to return with the child for follow-up visits.
  • Is HIV-positive.
  • Is generally healthy.
  • Is able to swallow medication in capsule form.
  • Has never taken d4T or has never taken 3TC.
  • Agrees to use barrier methods of birth control (such as condoms) during the study. The pill is not allowed during the study.
  • Exclusion Criteria
  • Your child will not be eligible for this study if he/she:
  • Has a serious infection at the time of study entry.
  • Has a history of severe diarrhea.
  • Is unable to take any of the medications in this study for any reason.
  • Has a history of certain serious illnesses.
  • Has taken any protease inhibitors (PIs).
  • Has taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz (EFV), within 2 weeks prior to study entry.
  • Has taken certain medications.
  • Is pregnant or breast-feeding.

Attachments

readout_NCT00000901_2024-03-02.pdf

4.5 MB

NCT00000901_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

La Jolla, California, United States

San Francisco, California, United States

New Haven, Connecticut, United States

Miami, Florida, United States

Boston, Massachusetts, 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

Syracuse, New York, United States

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

San Juan, , Puerto Rico

Jacksonville, Florida, United States

Gainesville, 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
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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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