Search / Trial NCT00000952

A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children

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

Trial Information

Current as of November 14, 2024

Completed

Keywords

Dose Response Relationship, Drug Drug Therapy, Combination Zidovudine Hiv Protease Inhibitors Ritonavir Lamivudine Anti Hiv Agents

ClinConnect Summary

As a group, vertically infected children experience more rapid disease progression than children infected at an older age or adults. The early administration of potent antiretroviral regimens might significantly impact the course of vertical HIV-1 infection.

Infants and children are stratified by age, representative of the developmental differences related to drug metabolism (Group I: at least 6 months - 2 years, Group II: 3-6 months, Group IIIA: 1 month - 10 weeks, IIIB: 1 month - less than 3 months). Within each age group there will be two possible dosage cohorts. All age groups will be ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Children may be eligible for this study if they:
  • Are HIV-positive. (Infants under 3 months old presumed to be HIV-positive are eligible to participate in the single-dose phase of the study.)
  • Are between the ages of 4 weeks and 2 years (consent of parent or guardian required).
  • Exclusion Criteria
  • Children will not be eligible for this study if they:
  • Have an opportunistic (AIDS-related) infection within 2 months of study entry.
  • Are allergic to 3TC and/or ZDV.
  • Have received anti-HIV drugs for 6 to 12 weeks.
  • Have any infections requiring treatment.
  • Are experiencing wasting (significant weight loss).
  • Have any malignancies (cancer).
  • Have certain immune diseases, are being fed through a tube, or have HIV-related encephalopathy (a degenerative disease of the brain).

Trial Officials

Ram Yogev

Study Chair

Ellen Chadwick

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

San Diego, California, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Long Beach, California, United States

Washington, District Of Columbia, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Memphis, Tennessee, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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