Non-comparative, Opened Study, Evaluating in HIV-1 Infected Patients With Undetectable Viral Load, Treated by an Antiretroviral Combination Including a Protease Inhibitor Boosted With Ritonavir and Administered by Oral Route Twice a Day, the Substitutability of the Current Protease Inhibitor Regimen by the Association Darunavir/Ritonavir 800/100 mg Once a Day to Maintain the Viral Load Under the 50 Copies/ml Limit of Detection After 24 Weeks of Treatment.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Undetectable viral load ( < 50 copies/ml)
研究概览
简要总结
Darunavir boosted with ritonavir (darunavir/r) is a powerful protease inhibitor, able to reduce the viral load in patients infected with multi-resistant HIV strains; In vitro and in vivo studies have shown that the induction of resistance mutations in the protease gene is much more difficult with the association darunavir/r compared to the other ritonavir-boosted protease inhibitors (PI/r), testifying of a significantly higher genetic barrier to resistance. Moreover, the tolerance to darunavir is good, and the pharmacologic profile of this molecule allows a once daily administration with a 800/100 mg dose in patients infected with a wild HIV strain or with a slightly resistant to darunavir/r strain.
Thus, we propose to evaluate the efficacy of the darunavir/r association once daily as a substitute to a protease inhibitor regimen administered twice daily in patients with undetectable viral load receiving a tritherapy including a protease inhibitor administered twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •HIV-1 infected patients
- •Treatment with an association of 3 molecules including two Nucleotidic Reverse Trasncriptase Inhibitors and a ritonavir-boosted protease inhibitor BID, unchanged for at least one month
- •At least two documented undetectable viral loads (under 50 copies/ml) within the last 3 months
- •Naiive from darunavir
- •Free from any opportunistic infection
- •Creatinin < 3N
- •ASAT & ALAT < 5N
- •Haemoglobin > 7 g/dl
- •Platelets > 50 000/mm3
- •Negative pregnancy test for women of childbearing potential and use of a mechanic contraceptive during sexual relationships
- •Signed informed consent
排除标准
- •HIV-2 infected patients
- •Treatment different from the association described in the inclusion criteria (2 NRTIs + 1 PI/r BID)
- •Patients with a documented problem of treatment compliance within the last 12 months
- •Ongoing active treatment against any opportunistic infection or tuberculosis
- •Any critic concomitant condition (alcohol consumption, fatigue) that may jeopardize treatment compliance and/olr tolerance, and interfere with the protocol compliance
- •Any concomitant treatment that may potentialize or inhibit hepatic cyotchrome-based enzymes
- •Patient already treated with darunavir
- •Patient treated with tipranavir, enfuvirtide, raltegravir, etravirine, and/or maraviroc
研究组 & 干预措施
Darunavir/r
干预措施: darunavir (Drug)
结局指标
主要结局
Undetectable viral load ( < 50 copies/ml)
时间窗: Week 24
次要结局
- Spermatic viral load (sub-study concerning 15 patients)(Day 0 and Week 48)
- Proportion of patients with undetectable viral load under 50 copies/ml(All visits)
- Pharmacologic sub-studies(All visits)
- Proportion of patients in the situation of virologic failure defined as a viral load higher than 50 copies/ml confirmed with a second examen at least two weeks later.(All visits)
- CD4 lymphocytes count and evolution(All visits)
- Lipids balance evolution(All visits)
- Treatment tolerance(All visits)
- Measure of the darunavir/r concentrations variability and correlation with the potential adverse events and/or virologic failures.(All visits)