Clinical trial NCT00000901: Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Dose-Response Relationship, Drug
Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
Lamivudine
Indinavir
RNA, Viral
Reverse Transcriptase Inhibitors
Viral Load
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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. \[AS PER AMENDMENT 4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.\]

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Med Ctr / Pediatrics / Clinical Sciences
state: California
city: San Francisco
country: United States
facility: UCSF / Moffitt Hosp - Pediatric
state: California
city: New Haven
country: United States
facility: Yale Univ Med School
state: Connecticut
city: Gainesville
country: United States
facility: Univ of Florida Gainesville
state: Florida
city: Jacksonville
country: United States
facility: Univ of Florida Health Science Ctr / Pediatrics
state: Florida
city: Miami
country: United States
facility: Univ of Miami (Pediatric)
state: Florida
city: Boston
country: United States
facility: Children's Hosp of Boston
state: Massachusetts
city: Great Neck
country: United States
facility: North Shore Univ Hosp
state: New York
city: New Hyde Park
country: United States
facility: Schneider Children's Hosp
state: New York
city: New York
country: United States
facility: Bellevue Hosp / New York Univ Med Ctr
state: New York
city: New York
country: United States
facility: Columbia Presbyterian Med Ctr
state: New York
city: New York
country: United States
facility: Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
state: New York
city: Syracuse
country: United States
facility: SUNY Health Sciences Ctr at Syracuse / Pediatrics
state: New York
city: Durham
country: United States
facility: Duke Univ Med Ctr
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hosp of Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Med Univ of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Saint Jude Children's Research Hosp of Memphis
state: Tennessee
city: Seattle
country: United States
facility: Children's Hospital & Medical Center / Seattle ACTU
state: Washington
city: San Juan
country: Puerto Rico
facility: San Juan City Hosp
Study officials:
name: John Sleasman
role: STUDY_CHAIR
name: Ross McKinney
role: STUDY_CHAIR
References: