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

Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children

Sponsors

Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Source National Institute of Allergy and Infectious Diseases (NIAID)
Brief Summary

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.

Detailed Description

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.]

Overall Status Completed
Completion Date October 2000
Phase Phase 1
Study Type Interventional
Enrollment 24
Condition
Intervention

Intervention type: Drug

Intervention name: Indinavir sulfate

Intervention type: Drug

Intervention name: Lamivudine

Intervention type: Drug

Intervention name: Stavudine

Eligibility

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.

Gender: All

Minimum age: 3 Years

Maximum age: 15 Years

Healthy volunteers: No

Overall Official
Location
facility
UCSD Med Ctr / Pediatrics / Clinical Sciences | La Jolla, California, 920930672, United States
UCSF / Moffitt Hosp - Pediatric | 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
Location Countries

Puerto Rico

United States

Verification Date

February 2012

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary purpose: Treatment

Source: ClinicalTrials.gov