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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000901 |
Purpose
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.
| Condition | Intervention | Phase |
|
HIV Infections |
Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine |
Phase I |
| MedlinePlus related topics: | AIDS |
| ChemIDplus related topics: | Lamivudine Indinavir Indinavir Sulfate Stavudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Safety Study |
| 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 |
| Estimated Enrollment: | 24 |
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
| Ages Eligible for Study: | 3 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Your child may be eligible for this study if he/she:
Exclusion Criteria
Your child will not be eligible for this study if he/she:
Contacts and Locations| United States, California | |||||
| UCSF / Moffitt Hosp - Pediatric | |||||
| San Francisco, California, United States, 941430105 | |||||
| UCSD Med Ctr / Pediatrics / Clinical Sciences | |||||
| La Jolla, California, United States, 920930672 | |||||
| United States, Connecticut | |||||
| Yale Univ Med School | |||||
| New Haven, Connecticut, United States, 06504 | |||||
| United States, Florida | |||||
| Univ of Miami (Pediatric) | |||||
| Miami, Florida, United States, 33161 | |||||
| Univ of Florida Health Science Ctr / Pediatrics | |||||
| Jacksonville, Florida, United States, 32209 | |||||
| Univ of Florida Gainesville | |||||
| Gainesville, Florida, United States, 32610 | |||||
| United States, Massachusetts | |||||
| Children's Hosp of Boston | |||||
| Boston, Massachusetts, United States, 021155724 | |||||
| United States, New York | |||||
| North Shore Univ Hosp | |||||
| Great Neck, New York, United States, 11021 | |||||
| Schneider Children's Hosp | |||||
| New Hyde Park, New York, United States, 11040 | |||||
| Bellevue Hosp / New York Univ Med Ctr | |||||
| New York, New York, United States, 10016 | |||||
| Columbia Presbyterian Med Ctr | |||||
| New York, New York, United States, 10032 | |||||
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | |||||
| Syracuse, New York, United States, 13210 | |||||
| Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | |||||
| New York, New York, United States, 10032 | |||||
| United States, North Carolina | |||||
| Duke Univ Med Ctr | |||||
| Durham, North Carolina, United States, 277103499 | |||||
| United States, Pennsylvania | |||||
| Children's Hosp of Philadelphia | |||||
| Philadelphia, Pennsylvania, United States, 191044318 | |||||
| United States, South Carolina | |||||
| Med Univ of South Carolina | |||||
| Charleston, South Carolina, United States, 294253312 | |||||
| United States, Tennessee | |||||
| Saint Jude Children's Research Hosp of Memphis | |||||
| Memphis, Tennessee, United States, 381052794 | |||||
| United States, Washington | |||||
| Children's Hospital & Medical Center / Seattle ACTU | |||||
| Seattle, Washington, United States, 981050371 | |||||
| Puerto Rico | |||||
| San Juan City Hosp | |||||
| San Juan, Puerto Rico, 009367344 | |||||
| Study Chair: | John Sleasman | |
| Study Chair: | Ross McKinney |
More Information
Click here for more information about Stavudine 
  |
Click here for more information about Lamivudine 
  |
Click here for more information about Indinavir sulfate 
  |
| Study ID Numbers: | ACTG 395 |
| First Received: | November 2, 1999 |
| Last Updated: | July 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000901 |
| Health Authority: | United States: Federal Government |
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