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Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Lopinavir/Ritonavir
Emtricitabine
Stavudine
Sponsored by
Triangle Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics, ABT 378, emtricitabine

Eligibility Criteria

3 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria Children may be eligible for this study if they: Are at least 3 months old and no older than 17 years of age. This is the age the child needs to be at the time they begin the study. Are HIV positive. Weigh more than 5.5 pounds. A newborn child must have reached at least 38 weeks of gestation. Have or have not taken anti-HIV drugs. Those that have not must have a viral load between 5,000 and 500,000 copies/ml at screening. Those that have must have been taking anti-HIV drugs, including lamivudine, for at least 3 months and have a viral load of no more than 400 copies/ml at screening. Have a CD4 count of more than 200 cells/mm3. Have written consent from parent or guardian. Are willing to use effective birth control during the study and for 1 month after the last dose of emtricitabine, if sexually active. Exclusion Criteria Children will not be eligible for this study if they: Are pregnant or breast-feeding. Cannot follow the visit or dosing schedule or are not available for 1 year. Have taken experimental drugs or vaccines (except for emivirine and experimental forms of approved drugs) within 30 days of study start. Have nerve damage in their arms or legs. Have trouble eating or taking drugs. Have serious diarrhea within 30 days before study entry. Have had any serious illness within 30 days of study screening. Any treatment must have been finished 14 days before study entry. Have had an AIDS-related (opportunistic) disease within 12 months of screening. Are being treated for tuberculosis. Have had pancreatitis. Require certain drugs.

Sites / Locations

  • USC School of Medicine / LA County Med Ctr
  • Univ of Florida Health Science Ctr / Pediatrics
  • Univ of Miami
  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
  • New York Hosp / Cornell Med Ctr
  • St Luke's - Roosevelt Hosp Ctr
  • State Univ of New York at Stony Brook
  • Saint Jude Children's Research Hosp of Memphis
  • Fundacion HUES
  • Instituto Mexicano de Investigacion Clinica
  • Hospital del Nino
  • Univ of Puerto Rico / Med Science Campus
  • Perinatal HIV Research UNITRecruiting
  • Infectious Diseases Clinincal Trial UnitRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 23, 2001
Last Updated
June 23, 2005
Sponsor
Triangle Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00017992
Brief Title
Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
Official Title
An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Triangle Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
Detailed Description
Children are placed into 1 of 4 treatment groups based on age: Group 1, 3 months to 24 months; Group 2, 25 months to 6 years; Group 3, 7 years to 12 years; Group 4, 13 years to 17 years. They receive baseline evaluations. Antiretroviral-naive patients receive emtricitabine plus stavudine plus lopinavir/ritonavir. Antiretroviral-experienced patients replace lamivudine with emtricitabine. Patients return to the clinic for follow-up visits at Weeks 2 and 4 and then every 4 weeks until Week 48. Safety is evaluated using adverse events, which are reviewed at every clinic visit. Clinical laboratory data and full-profile pharmacokinetics of emtricitabine are evaluated at some visits. After the Week 48 study evaluations are completed, individual patients may continue to receive study medication (as provided by the sponsor) until commercially available, if certain criteria are met.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Ritonavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Pharmacokinetics, ABT 378, emtricitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lopinavir/Ritonavir
Intervention Type
Drug
Intervention Name(s)
Emtricitabine
Intervention Type
Drug
Intervention Name(s)
Stavudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Children may be eligible for this study if they: Are at least 3 months old and no older than 17 years of age. This is the age the child needs to be at the time they begin the study. Are HIV positive. Weigh more than 5.5 pounds. A newborn child must have reached at least 38 weeks of gestation. Have or have not taken anti-HIV drugs. Those that have not must have a viral load between 5,000 and 500,000 copies/ml at screening. Those that have must have been taking anti-HIV drugs, including lamivudine, for at least 3 months and have a viral load of no more than 400 copies/ml at screening. Have a CD4 count of more than 200 cells/mm3. Have written consent from parent or guardian. Are willing to use effective birth control during the study and for 1 month after the last dose of emtricitabine, if sexually active. Exclusion Criteria Children will not be eligible for this study if they: Are pregnant or breast-feeding. Cannot follow the visit or dosing schedule or are not available for 1 year. Have taken experimental drugs or vaccines (except for emivirine and experimental forms of approved drugs) within 30 days of study start. Have nerve damage in their arms or legs. Have trouble eating or taking drugs. Have serious diarrhea within 30 days before study entry. Have had any serious illness within 30 days of study screening. Any treatment must have been finished 14 days before study entry. Have had an AIDS-related (opportunistic) disease within 12 months of screening. Are being treated for tuberculosis. Have had pancreatitis. Require certain drugs.
Facility Information:
Facility Name
USC School of Medicine / LA County Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Univ of Florida Health Science Ctr / Pediatrics
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Univ of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
331016960
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
New York Hosp / Cornell Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
State Univ of New York at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948111
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Saint Jude Children's Research Hosp of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
381052794
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Fundacion HUES
City
Buenos Aires
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Instituto Mexicano de Investigacion Clinica
City
Col Roma
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Hospital del Nino
City
Panama City
Country
Panama
Individual Site Status
Active, not recruiting
Facility Name
Univ of Puerto Rico / Med Science Campus
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Individual Site Status
Active, not recruiting
Facility Name
Perinatal HIV Research UNIT
City
Diepkloof
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Avy Violari
Phone
011+27 11 989 9700
Email
violari@mweb.co.za
Facility Name
Infectious Diseases Clinincal Trial Unit
City
Gaunteng
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Francesca Conradie
Phone
011+ 27 11 717 2810
Email
francesca_conradie@witshealth.co.za

12. IPD Sharing Statement

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Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV

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