Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment

A Phase I/II Trial of Ritonavir and Indinavir in Children Failing Other Antiretroviral Therapy

Both ritonavir (RTV) and indinavir (IDV) are approved by the FDA to treat HIV, but IDV has not been approved for use in children and the doses for the combination of the two drugs has not been studied in children. The purpose of this study is to find a combination of RTV and IDV that is safe, well tolerated, and produces drug levels in the blood of children that are comparable to effective drug levels in the blood of adults. The effectiveness of the drug combination in decreasing the amount of virus in the body will also be studied. The children enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs.

Study Overview

Status

Completed

Conditions

Detailed Description

Combination regimens of RTV and IDV in adults offer the benefit of two potent antiretroviral agents, convenience of twice-daily dosing, unrestricted timing of meals, and fewer renal complications. There are limited, largely anecdotal data from children suggesting that initial virologic response can also be attained in children given IDV with RTV, but there are not sufficient pharmacokinetic data to define appropriate dose regimens. This study will evaluate the clinical feasibility of a combination RTV and IDV regimen for children.

Patients will be stratified on the basis of age/Tanner stage and ability to swallow intact capsules. Patients will be randomized to either Balanced Dose or Low Dose RTV treatment arms. Patients in the Balanced Dose Arm will receive RTV and IDV in approximately equal doses. The Low Dose RTV Arm will receive a dosing ratio of RTV:IDV of approximately 1:3. Patients will have scheduled study visits every 4 weeks for 6 months, then every 3 months for approximately 18 months. Study visits will consist of a medical history, physical exam, and blood and urine tests. Patients will have intensive pharmacokinetic analysis at Week 4 (or 2 weeks after a stable dose of study drugs has been reached) and Week 16. Study visits that include pharmacokinetic analysis will last 9 to 13 hours.

At each study visit, patients will be closely assessed for drug toxicity and virologic response. At the end of the study, patients with good virologic response and no evidence of toxicity may choose to enter a 48 week extension phase and continue taking the combination regimen.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp. PR NICHD CRS
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard Univ. Washington DC NICHD CRS
    • Florida
      • Gainesville, Florida, United States, 32610
        • Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy
      • Jacksonville, Florida, United States, 32209
        • Univ. of Florida Jacksonville NICHD CRS
    • Illinois
      • Chicago, Illinois, United States, 606143394
        • Chicago Children's CRS
    • New York
      • New York, New York, United States, 10032
        • Columbia IMPAACT CRS
      • New York, New York, United States, 10037
        • Harlem Hosp. Ctr. NY NICHD CRS
      • New York, New York, United States, 10029
        • Metropolitan Hosp. Ctr.
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Med. Univ., Dept. of Peds.
    • Tennessee
      • Memphis, Tennessee, United States, 381052794
        • St. Jude/UTHSC CRS
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hosp. CRS
    • Virginia
      • Richmond, Virginia, United States, 23219
        • VCU Health Systems, Dept. of Peds

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • HIV infection
  • HIV RNA levels > 10,000 copies/ml within 30 days prior to study entry
  • Anti-HIV drug therapy failure while on the same anti-HIV drugs for more than 16 weeks
  • Body size above a certain limit (body surface area > 0.48 m2)
  • Acceptable methods of contraception
  • Consent of parent or legal guardian

Exclusion Criteria

  • Unable to determine HIV genotypic resistance
  • HIV resistant to IDV or RTV at study screening
  • Previously received IDV and RTV at the same time
  • Need treatment with any medication prohibited by the study
  • Glucocorticoids for more than 14 days at study entry
  • Cancer requiring chemotherapy
  • Drugs affecting the immune system, other than IVIG, within 3 months of study entry
  • Certain abnormal laboratory results at study entry
  • Pregnant or breast-feeding
  • Unable to be followed at a PACTG center during the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Ram Yogev
  • Study Chair: Ellen Chadwick
  • Study Chair: Stephen Pelton
  • Study Chair: Elaine Abrams

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

March 10, 2001

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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