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	Treatment or Intervention	Phase
HIV Infections	Drug: Indinavir sulfate  Drug: Lamivudine  Drug: Stavudine	Phase I

Further Study Details: 

Expected Total 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   -   15 Years,  Genders Eligible for Study:  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.

California
      UCSF / Moffitt Hosp - Pediatric, San Francisco,  California,  941430105,  United States
      UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla,  California,  920930672,  United States
Connecticut
      Yale Univ Med School, New Haven,  Connecticut,  06504,  United States
Florida
      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
Massachusetts
      Children's Hosp of Boston, Boston,  Massachusetts,  021155724,  United States
New York
      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
North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  277103499,  United States
Pennsylvania
      Children's Hosp of Philadelphia, Philadelphia,  Pennsylvania,  191044318,  United States
South Carolina
      Med Univ of South Carolina, Charleston,  South Carolina,  294253312,  United States
Tennessee
      Saint Jude Children's Research Hosp of Memphis, Memphis,  Tennessee,  381052794,  United States
Washington
      Children's Hospital & Medical Center / Seattle ACTU, Seattle,  Washington,  981050371,  United States
Puerto Rico
      San Juan City Hosp, San Juan,  009367344,  Puerto Rico

Study chairs or principal investigators

John Sleasman,  Study Chair
Ross McKinney,  Study Chair

Study ID Numbers:  ACTG 395
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000901
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08