NCT01420523终止2 期
Phase II Pilot Study Evaluating the Efficacy of Dual Therapy With Raltegravir Plus Maraviroc in Patients Receiving Suppressive Antiretroviral Therapy and Presenting With Lipohypertrophy (ANRS 157 ROCnRAL).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Virological failure
研究概览
简要总结
Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.
详细描述
Assess the ability to maintain the plasma HIV viral load below the threshold needed for detection (< 50 copies/mL) at 24 weeks of raltegravir/maraviroc therapy without NRTIs and PIs, in patients with virological success and presenting with clinical lipohypertrophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients infected with HIV-1 type B or CRF
- •≥ 18 years old
- •Patients who have been receiving antiretroviral therapy for at least 5 years, and whose treatment has been stable for at least 6 months.
- •Patients whose plasma viral load has been undetectable (below 200 copies/mL) over the last 24 months, and < 50 copies/mL for at least 12 months.
- •Patients with an R5* tropic virus, as determined through DNA and with CD4 nadir ≥ 100/mm3
- •Patients presenting with clinical lipohypertrophy recognized by themselves and by their doctors, and defined by increased volume of the abdominal and/or thoracic and/or cervical area (buffalo hump).
- •Patients who have never been treated with raltegravir.
- •Patients who have never been treated with maraviroc.
- •Efficient contraception for women
- •Free and informed written consent, signed by the patient and the investigator.
- •Patients with health insurance. * To increase the certainty of selecting patients with an R5 virus, the HIV-1 tropism will be determined by the genotype method and interpreted with the Geno2pheno[coreceptor] algorithm and a false positive rate threshold for X4 virus at 20%, rather than the usual 10%.
排除标准
- •X4, X4/5 or undetermined tropism of the HIV virus.
- •HIV-2 or coinfection HIV-1/HIV-
- •Chronic viral hepatitis B.
- •Chronic viral hepatitis C requiring specific treatment over the first 24 weeks.
- •Treatment with growth hormones.
- •Hypolipemic or diabetes treatment, begun within the last 3 months.
- •Pregnant or breastfeeding women.
- •Haemoglobin < 7g/dl, neutrophils < 500/mm3, platelets < 50 000/mm3, creatinine clearance < 50 mL/min, alkaline phosphatases, ASAT, ALAT or bilirubin ≥ 3 times the upper limit of the normal range (N).
- •Antiretroviral treatment associated to enzymatic inducer.
- •Chronic alcohol consumption.
- •Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship.
- •Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase.
研究组 & 干预措施
Raltegravir-Maraviroc
Experimental
Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day
干预措施: Raltegravir-Maraviroc (Drug)
结局指标
主要结局
Virological failure
时间窗: Week 24
Occurrence of virological failure, as verified by 2 consecutive plasma viral load measurements \> 50 copies/mL, taken 2 to 4 weeks apart at most, during the first 24 weeks.
次要结局
- Viro-immunological efficacy(Between baseline and W48)
- Tolerability criteria and metabolic impact(Between baseline and W48)
- Quality of life(Between baseline and W48)
- Compliance(Between baseline and W48)
研究者
研究点 (1)
Loading locations...
相似试验
终止
4 期
Kaletra and Maraviroc in Antiretroviral Therapy (ART)-Naive Patients (KALMAR Study)HIV InfectionsNCT01068873Temple University1
Unknown
4 期
Pilot Study With Isentress (Raltegravir) and Epzicom (Abacavir/Lamivudine) in Treatment Naive HIV-Infected SubjectsHIV InfectionsNCT00740064Denver Infectious Disease Consultants, PLLC30
已完成
2 期
Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected AdultsHIV-1 InfectionsNCT00830804Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections113
已完成
3 期
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (MK0518-018 EXT2)HIV InfectionsNCT00293267Merck Sharp & Dohme LLC352
Unknown
4 期
Triple vs. Double Therapy in naïves HIV-Infected PatientsHIV InfectionNCT04295460Hospitales Universitarios Virgen del Rocío70