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

This study is currently recruiting participants.

Verified by NIH AIDS Clinical Trials Information Service, March 2003

First Received: June 23, 2001 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Triangle Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00017992

Purpose

The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.

Condition	Intervention	Phase
HIV Infections	Drug: Lopinavir/Ritonavir Drug: Emtricitabine Drug: Stavudine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Pharmacodynamics Study
Official Title:	An Open-Label Study of a Once Daily Dose of Emtricitabine in Combination With Other Antiretroviral Agents in HIV-Infected Pediatric Patients

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Ritonavir Lopinavir Stavudine

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment:

100

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.

Eligibility

Ages Eligible for Study:	3 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017992

Locations

United States, California
USC School of Medicine / LA County Med Ctr	Active, not recruiting
Los Angeles, California, United States, 90033
United States, Florida
Univ of Miami	Active, not recruiting
Miami, Florida, United States, 331016960
Univ of Florida Health Science Ctr / Pediatrics	Active, not recruiting
Jacksonville, Florida, United States, 32209
United States, New York
New York Hosp / Cornell Med Ctr	Active, not recruiting
New York, New York, United States, 10021
State Univ of New York at Stony Brook	Active, not recruiting
Stony Brook, New York, United States, 117948111
St Luke's - Roosevelt Hosp Ctr	Active, not recruiting
New York, New York, United States, 10025
Bronx Municipal Hosp Ctr/Jacobi Med Ctr	Active, not recruiting
Bronx, New York, United States, 10461
United States, Tennessee
Saint Jude Children's Research Hosp of Memphis	Active, not recruiting
Memphis, Tennessee, United States, 381052794
Argentina
Fundacion HUES	Active, not recruiting
Buenos Aires, Argentina
Mexico
Instituto Mexicano de Investigacion Clinica	Active, not recruiting
Col Roma, Mexico
Panama
Hospital del Nino	Active, not recruiting
Panama City, Panama
Puerto Rico
Univ of Puerto Rico / Med Science Campus	Active, not recruiting
San Juan, Puerto Rico, 00936
South Africa
Infectious Diseases Clinincal Trial Unit	Recruiting
Gaunteng, South Africa
Contact: Pauline Francesca Conradie 011+ 27 11 717 2810 francesca_conradie@witshealth.co.za
Perinatal HIV Research UNIT	Recruiting
Diepkloof, South Africa
Contact: Dr. Avy Violari 011+27 11 989 9700 violari@mweb.co.za

Sponsors and Collaborators

Triangle Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	298D, FTC-203
Study First Received:	June 23, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00017992 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV-1
Drug Administration Schedule
Stavudine
HIV Protease Inhibitors
Ritonavir

Reverse Transcriptase Inhibitors
Anti-HIV Agents
Pharmacokinetics
ABT 378
emtricitabine

Study placed in the following topic categories:

Antimetabolites
Sexually Transmitted Diseases, Viral
HIV Protease Inhibitors
Anti-HIV Agents
Stavudine
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors

Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
Emtricitabine
Lopinavir
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Stavudine
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Emtricitabine
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on July 02, 2009