Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Lamivudine (Drug); Stavudine (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
John Sleasman, Study Chair
Ross McKinney, Study Chair
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.
Clinical Details
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 design: Treatment, Safety Study
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.]
Eligibility
Minimum age: 3 Years.
Maximum age: 15 Years.
Gender(s): Both.
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.
Locations and Contacts
San Juan City Hosp, San Juan 009367344, Puerto Rico
UCSF / Moffitt Hosp - Pediatric, San Francisco, California 941430105, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California 920930672, United States
Yale Univ Med School, New Haven, Connecticut 06504, United States
Univ of Miami (Pediatric), Miami, Florida 33161, United States
Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida 32209, United States
Univ of Florida Gainesville, Gainesville, Florida 32610, United States
Children's Hosp of Boston, Boston, Massachusetts 021155724, United States
North Shore Univ Hosp, Great Neck, New York 11021, United States
Schneider Children's Hosp, New Hyde Park, New York 11040, United States
Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States
Columbia Presbyterian Med Ctr, New York, New York 10032, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York 13210, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr, New York, New York 10032, United States
Duke Univ Med Ctr, Durham, North Carolina 277103499, United States
Children's Hosp of Philadelphia, Philadelphia, Pennsylvania 191044318, United States
Med Univ of South Carolina, Charleston, South Carolina 294253312, United States
Saint Jude Children's Research Hosp of Memphis, Memphis, Tennessee 381052794, United States
Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington 981050371, United States
Additional Information
Click here for more information about Stavudine Click here for more information about Lamivudine Click here for more information about Indinavir sulfate
Last updated: May 12, 2006
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