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

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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. In this multicenter, open-label study patients receive a combined drug regimen of indinavir, stavudine, and lamivudine over 48 weeks. Patients are evaluated at ... more

Medical trial

ClinicalTrials.gov Identifier:

  • NCT00000901

Sponsor:

Type of trial:

Design:

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Phase:

Expected total enrollment:

  • 24

Eligibile genders:

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Minimum age for eligibility:

  • 3

Maximum age for eligibility:

  • 15

Eligibility inclusion criteria:

  • Is HIV-positive.
  • Is generally healthy.
  • Is able to swallow medication in capsule form.
  • Has never taken d4T or has never taken 3TC.
  • # 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.
  • Agrees to use barrier methods of birth control (such as condoms) during the study. The pill is not allowed during the study.

Eligibility exclusion criteria:

  • Has a history of certain serious illnesses.
  • Is unable to take any of the medications in this study for any reason.
  • Has a history of severe diarrhea.
  • # Has a serious infection at the time of study entry.
  • Is pregnant or breast-feeding.
  • Has taken certain medications.
  • # Has taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz (EFV), within 2 weeks prior to study entry.
  • Has taken any protease inhibitors (PIs).

Health authority:

Diseases:

Treatment being tested:

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