IMPACT OF THERAPY INTENSIFICATION BY AN INTEGRASE INHIBITOR +/- CCR5 INHIBITOR ON THE LYMPHOID RESERVOIR FOR HIV-1 IN CHRONICALLY INFECTED PATIENTS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- residual plasma replication between 0 and 50 copies/ml
研究概览
简要总结
To determine the efficacy of adding Isentress®, with or without Celsentri®, to effective conventional antiretroviral therapy (comprising at least 2 reverse transcriptase inhibitors and one boosted protease inhibitor), on residual HIV replication and blood cell and gut-associated lymphoid tissue reservoirs (reverse transcriptase inhibitors: RTIs, boosted protease inhibitors: PI/r).
To evaluate the effect of therapy intensification by means of an integrase inhibitor with or without CCR5 inhibitor treatment on the lymphoid reservoir in patients chronically infected with HIV-1, successfully treated with "conventional triple therapy", measured by:
- residual plasma replication between 0 and 50 copies/ml
- intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL).
- proviral HIV DNA levels in PBMC and RL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female patients, aged over 18 years
- •HIV infection confirmed by Western Blot
- •Karnofsky score > 80%
- •Treatment-experienced patients having received combined antiretroviral therapy including at least 2 RTI and 1 PI/r for at least 12 months with plasma viral load <50 copies/ml for at least 6 months
- •Stable first-line treatment (or other, if changes were not made for reasons relating to viral resistance) with 2 RTIs and 1 PI/r
- •Proper safety and compliance for the ongoing combination;
- •Patient agreeing to undergo 3 proctosigmoidoscopy examinations over a 12-month period;
- •Plasma HIV-1 RNA <50 copies/ml at inclusion;
- •Circulating CD4 >200/mm3 at inclusion;
- •Isentress® and Celsentri®-naïve patients
- •No contraindications to the use of the investigational products
- •Written, informed consent, obtained from the patient or his/her legal representative.
排除标准
- •Opportunistic infection or active tumor disease
- •Chronic diarrhea, malabsorption, progressive enteric infection
- •Aged under 18 years
- •Pregnancy - breast-feeding ( a pregnancy test will be done at the inclusion visit)
- •Co-infection with HIV-2
- •History of immunomodulator treatment (interleukin-2, alpha-interferon)
- •Ongoing treatment of HBV or HCV co-infection
- •Blood constitution disorders
- •Contraindications to the administration of raltegravir or maraviroc
- •Circulating CD4 nadir <100/mm3 in the natural history of HIV-1 infection.
研究组 & 干预措施
HAART+Raltegravir 12 months (+/-) Maraviroc
干预措施: Isentress® (Drug)
HAART+Raltegravir 12 months (+/-) Maraviroc
干预措施: Celsentri® (Drug)
结局指标
主要结局
residual plasma replication between 0 and 50 copies/ml
时间窗: one year
proviral HIV DNA levels in PBMC and RL
时间窗: one year
intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL
时间窗: one year
次要结局
- CD4 counts(one year)
- CD8 activation levels(one year)