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

Trial Information

Current as of December 14, 2024

Completed

Keywords

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

ClinConnect Summary

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.

Trial Officials

John Sleasman

Study Chair

Ross McKinney

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

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

Discussion 0

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