Safety and Efficacy of Switching From Stavudine or Zidovudine to Tenofovir DF in HIV-1 Infected Children

NCT ID: NCT00528957

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-28
• Study Completion Date: 2017-08-16

Brief Summary

The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tenofovir DF

Group Type: EXPERIMENTAL

Tenofovir DF

Intervention Type: DRUG

Tenofovir DF (oral powder or tablet): 300-mg tablets for participants \> 37 kg; 8-mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg. During the extension phase, participants whose weight increases to \> 37 kg may be switched from the oral powder to the tenofovir DF tablet.

stavudine or zidovudine

Group Type: ACTIVE_COMPARATOR

Zidovudine

Intervention Type: DRUG

Zidovudine as prescribed by the investigator prior to study entry (pediatric participants \< 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily).

Stavudine

Intervention Type: DRUG

Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m\^2 every 8 hours; pediatric participants \> 12 years of age: 300 mg twice daily).

Interventions

Tenofovir DF

Tenofovir DF (oral powder or tablet): 300-mg tablets for participants \> 37 kg; 8-mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg. During the extension phase, participants whose weight increases to \> 37 kg may be switched from the oral powder to the tenofovir DF tablet.

Intervention Type: DRUG

Zidovudine

Zidovudine as prescribed by the investigator prior to study entry (pediatric participants \< 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily).

Intervention Type: DRUG

Stavudine

Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m\^2 every 8 hours; pediatric participants \> 12 years of age: 300 mg twice daily).

Intervention Type: DRUG

Other Intervention Names

Viread®

Eligibility Criteria

Inclusion Criteria

• Documented laboratory diagnosis of HIV-1 infection
• Plasma HIV-1 RNA < 400 copies/mL
• Currently on a stable stavudine or zidovudine -containing antiretroviral therapy regimen for at least 12 weeks
• Naive to tenofovir DF

• Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study
• <18 years of age (at the start of the extension)
• Participants initially randomized to Arm 2 will be given the option to replace stavudine or zidovudine with tenofovir DF in the 96-week extension at the investigator's discretion, if the investigator determines that tenofovir DF is safe and beneficial for the participant.

• Completed of treatment with study drug in the first extension phase
• <18 years of age at the start of the extension. This inclusion criterion is not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults.

Exclusion Criteria

• Participants receiving ongoing therapy with any of the following
• Nephrotoxic agents
• Systemic chemotherapeutic agents
• Systemic corticosteroids
• Interleukin 2 (IL 2) and other immunomodulating agents
• Investigational agents
• Pregnant or lactating participants
• Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication
• Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
• Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma.
• Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening
• Prior history of significant renal disease (ie, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis)
• Prior history of significant bone disease (ie, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures)

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Jeffrey Goodman Special Care Clinic

Los Angeles, California, United States

University California Los Angeles, School of Medicine, Pediatric, Infectious Diseases

Los Angeles, California, United States

Children's Diagnostic and Treatment Center, Inc

Fort Lauderdale, Florida, United States

University of Florida, Jacksonville

Jacksonville, Florida, United States

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Hospital del Nino

Panama City, , Panama

Great Ormond Street Hospital

London, , United Kingdom

Imperial College London, Paediatrics Infectious Diseases

London, , United Kingdom

Countries

United States; Panama; United Kingdom

References

Saez-Llorens X, Castano E, Rathore M, Church J, Deville J, Gaur A, Estripeaut D, White K, Arterburn S, Enejosa JV, Cheng AK, Chuck SL, Rhee MS. A randomized, open-label study of the safety and efficacy of switching stavudine or zidovudine to tenofovir disoproxil fumarate in HIV-1-infected children with virologic suppression. Pediatr Infect Dis J. 2015 Apr;34(4):376-82. doi: 10.1097/INF.0000000000000289.

Reference Type: DERIVED

PMID: 25760565 (View on PubMed)

Other Identifiers

2007-003418-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-104-0352

Identifier Type: -

Identifier Source: org_study_id