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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000901 |
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 |
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.]
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:
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 |
Study ID Numbers: | ACTG 395 |
Study First Received: | November 2, 1999 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00000901 |
Health Authority: | United States: Federal Government |
Dose-Response Relationship, Drug Drug Therapy, Combination Stavudine HIV Protease Inhibitors Lamivudine |
Indinavir RNA, Viral Reverse Transcriptase Inhibitors Viral Load |
Virus Diseases Sexually Transmitted Diseases, Viral Stavudine Indinavir HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lamivudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents Communicable Diseases HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |