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Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Indinavir sulfate
Lamivudine
Stavudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Dose-Response Relationship, Drug, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Reverse Transcriptase Inhibitors, Viral Load

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD Med Ctr / Pediatrics / Clinical Sciences
  • UCSF / Moffitt Hosp - Pediatric
  • Yale Univ Med School
  • Univ of Florida Gainesville
  • Univ of Florida Health Science Ctr / Pediatrics
  • Univ of Miami (Pediatric)
  • Children's Hosp of Boston
  • North Shore Univ Hosp
  • Schneider Children's Hosp
  • Bellevue Hosp / New York Univ Med Ctr
  • Columbia Presbyterian Med Ctr
  • Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
  • SUNY Health Sciences Ctr at Syracuse / Pediatrics
  • Duke Univ Med Ctr
  • Children's Hosp of Philadelphia
  • Med Univ of South Carolina
  • Saint Jude Children's Research Hosp of Memphis
  • Children's Hospital & Medical Center / Seattle ACTU
  • San Juan City Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000901
Brief Title
Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
Official Title
A Multicenter, Open-Labeled, 96-Week Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Indinavir in Combination With Stavudine and Lamivudine in Pediatric Patients With HIV-1 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
Detailed Description
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.]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Dose-Response Relationship, Drug, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Reverse Transcriptase Inhibitors, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Sleasman
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ross McKinney
Official's Role
Study Chair
Facility Information:
Facility Name
UCSD Med Ctr / Pediatrics / Clinical Sciences
City
La Jolla
State/Province
California
ZIP/Postal Code
920930672
Country
United States
Facility Name
UCSF / Moffitt Hosp - Pediatric
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Yale Univ Med School
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Univ of Florida Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Univ of Florida Health Science Ctr / Pediatrics
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
North Shore Univ Hosp
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Schneider Children's Hosp
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SUNY Health Sciences Ctr at Syracuse / Pediatrics
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
Children's Hosp of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191044318
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
294253312
Country
United States
Facility Name
Saint Jude Children's Research Hosp of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
381052794
Country
United States
Facility Name
Children's Hospital & Medical Center / Seattle ACTU
City
Seattle
State/Province
Washington
ZIP/Postal Code
981050371
Country
United States
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico

12. IPD Sharing Statement

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Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children

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