Randomised Double-blind Placebo Controlled Study to Measure the Effect of Antiretroviral Therapy (ART) Intensification With Raltegravir and/or Hyper-immune Bovine Colostrum on CD4+ T Cell Count in ART Treated, HIV-1 Infected Individuals With Suboptimal CD4+ T Cell Responses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Mean Change From Baseline CD4+ Cell Count
研究概览
简要总结
A research study to measure the effect on CD4 counts of adding to current anti-retroviral regimen raltegravir with or without hyper-immune bovine colostrum.
详细描述
The primary objective of this study is to measure the effect on CD4+ T cell outcome as measured by the mean time weighted CD4+ T cell count change over 24 weeks of two interventions: (I) cART intensification with raltegravir and (II) cART combined with hyper-immune bovine colostrum in HIV-1 infected individuals who have failed to achieve a CD4+ T cell count greater than 350 cells/µL despite persistent HIV plasma viraemia below 50 copies/mL on cART.
Eligible patients will be randomised to one of four arms. I. Raltegravir + hyper-immune bovine colostrum placebo II. Raltegravir placebo + hyper-immune bovine colostrum III. Raltegravir + hyper-immune bovine colostrum IV. Raltegravir placebo + hyper-immune bovine colostrum placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Documented HIV-1 infection
- •Age >18 years
- •Signed informed consent
- •Receiving combination ART (cART) for at least 12 months with a stable cART regimen for a minimum of 6 months. A formulation change or modification of dosage schedule is acceptable (for example ritonavir - boosted lopinavir capsules for tablets, abacavir (ABC) or tenofovir (TDF) and lamivudine (3TC) or emtricitabine (FTC) as single agents for ABC/3TC or TDF/FTC fixed dose combinations)
- •Two consecutive plasma HIV RNA viral load measurements <50 (or <400 copies/mL depending upon lowest level of detection of the local assay) in the 9 months preceding the screening visit. A single isolated HIV RNA viral load >50 (or >400) copies/mL will not exclude the patient provided the viral load result >50 (or 400) copies/mL on therapy follows a previous result <50 (or 400) copies/mL, and there is a follow-up result <50 copies/mL at least one week following the >50 (or 400) copies/mL reading in the absence of a change to any component of the ART regimen.
- •CD4+ T cell count <350 cells/µL throughout the 6 months preceding the screening visit with <50 cells/µL increase in the last 12 months
排除标准
- •Receiving a cART regimen containing an integrase inhibitor
- •Anticipated change of cART in the 24 weeks following randomisation
- •Participating in study with an investigational compound or device within 30 days of signing informed consent
- •Use of immune modulating therapies or immunosuppressive medications within 60 days prior to study entry. Patients using inhaled or nasal steroids are not excluded
- •Pregnant or breastfeeding woman
- •Cow's milk allergy
- •Concurrent treatment with phenobarbitol, phenytoin or rifampicin.
- •A known cause of impaired CD4+ T cell gain: for example, patients with splenomegaly or individuals whose current cART regimen contains both tenofovir and didanosine
研究组 & 干预措施
Raltegravir, bovine colostrum
Raltegravir and hyper-immune bovine colostrum
干预措施: raltegravir and hyper-immune bovine colostrum (Drug)
Hyper-immune bovine colostrum
Hyper-immune bovine colostrum and Raltegravir placebo
干预措施: Hyper-immune Bovine Colostrum (Drug)
Raltegravir
Raltegravir and Hyper-immune Bovine Colostrum Placebo
干预措施: Raltegravir (Drug)
Placebo
Raltegravir placebo and hyper-immune bovine colostrum placebo
干预措施: raltegravir placebo (Other)
Placebo
Raltegravir placebo and hyper-immune bovine colostrum placebo
干预措施: Hyper-immune Bovine Colostrum placebo (Other)
结局指标
主要结局
Mean Change From Baseline CD4+ Cell Count
时间窗: 24 weeks
Comparison of normalised mean change from baseline CD4+ cell count
次要结局
未报告次要终点