NCT00012519

Brief Summary

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2001

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

March 10, 2001

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

Dose-Response Relationship, DrugDrug Therapy, CombinationHIV Protease InhibitorsRitonavirIndinavirAnti-HIV AgentsViral LoadPharmacokineticsTreatment Experienced

Interventions

indinavir sulfateDRUG
ritonavirDRUG

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, 20060, United States

Location

Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy

Gainesville, Florida, 32610, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Chicago Children's CRS

Chicago, Illinois, 606143394, United States

Location

Metropolitan Hosp. Ctr.

New York, New York, 10029, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, 10037, United States

Location

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, 13210, United States

Location

St. Jude/UTHSC CRS

Memphis, Tennessee, 381052794, United States

Location

Texas Children's Hosp. CRS

Houston, Texas, 77030, United States

Location

VCU Health Systems, Dept. of Peds

Richmond, Virginia, 23219, United States

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 009367344, Puerto Rico

Location

Related Publications (3)

  • Saah AJ, Winchell GA, Nessly ML, Seniuk MA, Rhodes RR, Deutsch PJ. Pharmacokinetic profile and tolerability of indinavir-ritonavir combinations in healthy volunteers. Antimicrob Agents Chemother. 2001 Oct;45(10):2710-5. doi: 10.1128/AAC.45.10.2710-2715.2001.

    PMID: 11557459BACKGROUND

  • van Rossum AM, de Groot R, Hartwig NG, Weemaes CM, Head S, Burger DM. Pharmacokinetics of indinavir and low-dose ritonavir in children with HIV-1 infection. AIDS. 2000 Sep 29;14(14):2209-10. doi: 10.1097/00002030-200009290-00022. No abstract available.

    PMID: 11061667BACKGROUND

  • Chadwick EG, Rodman JH, Samson P, Fenton T, Abrams EJ, Nowak B, Pelton SI, Lavoie S, Knapp K, Bambji M, Yogev R, PACTG 1013 Team. Antiviral Activity, Tolerance and Pharmacokinetics of Indinavir with Two Doses of Ritonavir as Salvage Therapy in Children. 10th Conference on Retroviruses and Oppurtunistic Infections. Feb 2003. Abstract 875.

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

IndinavirRitonavir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsAzoles

Study Officials

  • Ellen Chadwick

    STUDY CHAIR

  • Ram Yogev

    STUDY CHAIR

  • Stephen Pelton

    STUDY CHAIR

  • Elaine Abrams

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2001

First Posted

August 31, 2001

Study Completion

July 1, 2005

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(11)PR(1)