NCT00000901

Brief Summary

The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children. IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
2 countries

19 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

November 2, 1999

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2000

Completed
11 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

October 28, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

Dose-Response Relationship, DrugDrug Therapy, CombinationStavudineHIV Protease InhibitorsLamivudineIndinavirRNA, ViralReverse Transcriptase InhibitorsViral Load

Interventions

Indinavir sulfateDRUG
LamivudineDRUG
StavudineDRUG

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, 920930672, United States

Location

UCSF / Moffitt Hosp - Pediatric

San Francisco, California, 941430105, United States

Location

Yale Univ Med School

New Haven, Connecticut, 06504, United States

Location

Univ of Florida Gainesville

Gainesville, Florida, 32610, United States

Location

Univ of Florida Health Science Ctr / Pediatrics

Jacksonville, Florida, 32209, United States

Location

Univ of Miami (Pediatric)

Miami, Florida, 33161, United States

Location

Children's Hosp of Boston

Boston, Massachusetts, 021155724, United States

Location

North Shore Univ Hosp

Great Neck, New York, 11021, United States

Location

Schneider Children's Hosp

New Hyde Park, New York, 11040, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Columbia Presbyterian Med Ctr

New York, New York, 10032, United States

Location

Incarnation Children's Ctr / Columbia Presbyterian Med Ctr

New York, New York, 10032, United States

Location

SUNY Health Sciences Ctr at Syracuse / Pediatrics

Syracuse, New York, 13210, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 277103499, United States

Location

Children's Hosp of Philadelphia

Philadelphia, Pennsylvania, 191044318, United States

Location

Med Univ of South Carolina

Charleston, South Carolina, 294253312, United States

Location

Saint Jude Children's Research Hosp of Memphis

Memphis, Tennessee, 381052794, United States

Location

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, 981050371, United States

Location

San Juan City Hosp

San Juan, 009367344, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections

Interventions

IndinavirLamivudineStavudine

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 CompoundsZalcitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDideoxynucleosidesThymidine

Study Officials

  • John Sleasman

    STUDY CHAIR

  • Ross McKinney

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

October 1, 2000

Last Updated

October 28, 2021

Record last verified: 2021-10

Locations

US(18)PR(1)