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

This study is ongoing, but not recruiting participants.
Study NCT00000901.   Last updated on July 11, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

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Descriptive Information Fields
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
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.]

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Indinavir sulfate
Drug: Lamivudine
Drug: Stavudine
MEDLINE PMIDs
Links Click here for more information about Stavudine This link exits the ClinicalTrials.gov site
Click here for more information about Lamivudine This link exits the ClinicalTrials.gov site
Click here for more information about Indinavir sulfate This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  24
Start Date 
Completion Date
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.
Gender Both
Ages 3 Years to 15 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Puerto Rico
Administrative Information Fields
NCT ID  NCT00000901
Organization ID ACTG 395
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ††
Investigators 
Study Chair:     John Sleasman        
Study Chair:     Ross McKinney        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date May 2006
First Received Date  November 2, 1999
Last Updated Date July 11, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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