Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
NCT ID: NCT00000901
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2000-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Indinavir sulfate
Lamivudine
Stavudine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
15 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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John Sleasman
Role: STUDY_CHAIR
Ross McKinney
Role: STUDY_CHAIR
Locations
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UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Yale Univ Med School
New Haven, Connecticut, United States
Univ of Florida Gainesville
Gainesville, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
North Shore Univ Hosp
Great Neck, New York, United States
Schneider Children's Hosp
New Hyde Park, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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Other Identifiers
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11351
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 395
Identifier Type: -
Identifier Source: org_study_id