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| ID | Type | Description | Link |
|---|---|---|---|
| 11351 | Registry Identifier | DAIDS ES |
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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.
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.]
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indinavir sulfate | Drug | |||
| Lamivudine | Drug | |||
| Stavudine | Drug |
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:
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| Name | Affiliation | Role |
|---|---|---|
| John Sleasman | Study Chair | |
| Ross McKinney | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Med Ctr / Pediatrics / Clinical Sciences | La Jolla | California | 920930672 | United States | ||
| UCSF / Moffitt Hosp - Pediatric |
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| San Francisco |
| California |
| 941430105 |
| United States |
| Yale Univ Med School | New Haven | Connecticut | 06504 | United States |
| Univ of Florida Gainesville | Gainesville | Florida | 32610 | United States |
| Univ of Florida Health Science Ctr / Pediatrics | Jacksonville | Florida | 32209 | United States |
| Univ of Miami (Pediatric) | Miami | Florida | 33161 | 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 |
| Incarnation Children's Ctr / Columbia Presbyterian Med Ctr | New York | New York | 10032 | United States |
| SUNY Health Sciences Ctr at Syracuse / Pediatrics | Syracuse | New York | 13210 | 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 |
| San Juan City Hosp | San Juan | 009367344 | Puerto Rico |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019469 | Indinavir |
| D019259 | Lamivudine |
| D018119 | Stavudine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
| D013936 | Thymidine |
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