EUCTR2007-003418-32-Outside-EU/EEA进行中（未招募）不适用
A Phase III, Randomized, Open-Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV-Infected Children Taking Highly Active Antiretroviral Therapy.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The following inclusion criteria will be applied to all subjects, including subjects currently
- •enrolled in Study GS-US-162-0111:
- •Male or female
- •2 years to < 12 years of age (consent of parent or guardian required)—Subjects currently
- •enrolled in Study GS-US-162-0111 must be 2 to < 16 years of age. If the study drug is
- •not commercially available in the country where the subject is enrolled, inclusion up to
- •< 18 years of age at the start of participation in the extension is permitted
- •Documented laboratory diagnosis of HIV infection (if no record exists, must be tested at
- •screening visit)
- •Plasma HIV-1 RNA < 400 copies/mL
- •Currently receiving stavudine or zidovudine containing antiretroviral therapy regimen for at least 12 weeks
- •Naive to tenofovir DF
- •Negative serum pregnancy test (post-menarchal females only)
- •Male and female subjects of childbearing potential must agree to utilize highly effective
- •contraception methods while on study treatment or agree to abstain from heterosexual
- •intercourse for 30 days following the last does of study drugs; highly effective methods
- •normally utilize two separate forms of contraception, one of which must be an effective
- •barrier contraceptive method.
- •Parent or guardian able to provide written informed consent prior to any screening evaluations and willing to comply with study requirements
- •Subject able to provide written assent if they have the ability to read and write
- •Inclusion Criteria for the First 96-Week Extension
- •Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study
- •Continues to be < 18 years of age (consent of parent or guardian required) at the start of
- •participation in the extension
- •Patients 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 patient. Patients will not participate in the study extension if they do not choose to receive open-label tenofovir DF.
- •Inclusion Criteria for the Second 96-Week Extension
- •Completed 144 weeks of treatment with study drug
- •Continues to be < 18 years of age (consent of parent or guardian required) at the start of participation in the extension. Not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults.
- •Inclusion Criteria for the Third 96-Week Extension
- •Completed 240 weeks of treatment with study drug
- •Continues to be < 18 years of age (consent of parent or guardian required) at the start of participation in the extension. Not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults.
- •Inclusion Criteria for the Long-Term Extension
- •Completed 336 weeks of treatment with study drug and have evidence of benefit from
- •tenofovir DF:
- •— HIV-1 RNA < 400 copies/mL at the Week 336 visit, or
- •— At least a 1 log10 decrease in HIV-1 RNA during the study, no evidence of TDF viral resistance at or prior to Week 336, and is expected to benefit from continued TDF therapy in the opinion of the investigator
- •Continues to be < 18 years of age (consent of parent or guardian required) at the start of participation in the extension.
- •Inclusion Criteria for the Long-Term Extension
- •Completed 336 weeks of treatment with study drug and have evidence of benefit from tenofovir DF:
排除标准
- •No exclusion criteria will be applied to subjects enrolling from Study GS-US-162-0111.
- •Subjects not currently enrolled in Study GS-US-162-0111 that meet any of the following exclusion criteria are not to be enrolled in this study:
- •Subjects receiving didanosine as part of the background regimen
- •Subjects receiving ongoing therapy with any of the following:
- •— Nephrotoxic agents
- •Aminoglycoside antibiotics
- •Cidofovir
- •Cisplatin
- •Foscarnet
- •IV amphotericin B
- •Voriconazole
- •IV pentamidine
- •IV vancomycin
- •Oral or IV ganciclovir
- •Probenecid
- •— Systemic chemotherapeutic agents
- •— Systemic corticosteroids
- •— Interleukin-2 (IL-2) and other immunomodulating agents
- •— Investigational agents (except with the expressed approval of the Sponsor)
- •Administration of any of the above medications must be discontinued at least 30 days prior to the Baseline Visit and for the duration of the study period.
- •Pregnant or lactating subjects
- •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
- •subject compliance
- •Malignancy other than cutaneous Kaposi’s sarcoma (KS) or basal cell carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received
- •any systemic therapy for KS within 30 days of baseline and are not anticipated to require systemic therapy during the study
- •Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening
- •Prior history of significant renal disease (i.e., nephrotic syndrome, renal dysgenesis,
- •polycystic kidney disease, congenital nephrosis)
- •Prior history of significant bone disease (i.e., osteomalacia, chronic osteomyelitis,
- •osteogenesis imperfecta, osteochondroses, multiple bone fractures)
- •Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for study or unable to comply with the dosing requirements
研究者
相似试验
进行中（未招募）
1 期
A Phase 3 study to evaluate safety and efficacy of the combination of for Bel- CHOP/ Fol-COP drugs against CHOP in newly diagnosed Peripheral T-Cell Lymphoma (blood cancer) patientsCTIS2023-507803-76-00Acrotech Biopharma Inc.499
进行中（未招募）
1 期
Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple MyelomaRelapsed and/or Refractory Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2016-004742-28-DEMillennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda300
进行中（未招募）
1 期
Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple MyelomaRelapsed and/or Refractory Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2016-004742-28-NLMillennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda122
进行中（未招募）
1 期
Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple MyelomaRelapsed and/or Refractory Multiple MyelomaMedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2016-004742-28-ESMillennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda122
进行中（未招募）
1 期
Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple MyelomaRelapsed and/or Refractory Multiple MyelomaMedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2016-004742-28-BEMillennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda300