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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 |
| 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
| Study ID Numbers: | ACTG 395 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000901 History of Changes |
| 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 |
|
Antimetabolites Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Stavudine Indinavir Acquired Immunodeficiency Syndrome Lamivudine Antiviral Agents |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Protease Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
|
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Indinavir Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
