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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2003 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00017992
First received: June 23, 2001
Last updated: June 23, 2005
Last verified: March 2003
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Florida Health Science Ctr / Pediatrics Active, not recruiting
Jacksonville, Florida, United States, 32209
Univ of Miami Active, not recruiting
Miami, Florida, United States, 331016960
United States, New York
Bronx Municipal Hosp Ctr/Jacobi Med Ctr Active, not recruiting
Bronx, New York, United States, 10461
St Luke's - Roosevelt Hosp Ctr Active, not recruiting
New York, New York, United States, 10025
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
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
Perinatal HIV Research UNIT Recruiting
Diepkloof, South Africa
Contact: Dr. Avy Violari    011+27 11 989 9700    violari@mweb.co.za   
Infectious Diseases Clinincal Trial Unit Recruiting
Gaunteng, South Africa
Contact: Pauline Francesca Conradie    011+ 27 11 717 2810    francesca_conradie@witshealth.co.za   
Sponsors and Collaborators
Triangle Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00017992     History of Changes
Other Study ID Numbers: 298D, FTC-203
Study First Received: June 23, 2001
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Ritonavir
Lopinavir
Stavudine
Reverse Transcriptase Inhibitors
Emtricitabine
Anti-Retroviral Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014