Clinical Study to Evaluate the Efficacy and Safety of Gammora® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral Treatment-Naïve Participants
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Total Proviral HIV DNA quantitation
研究概览
简要总结
The goal of this phase II, open-label, randomized, controlled clinical trial is to evaluate the impact of Gammora®, a 16-mer HIV integrase-derived peptide associated with a boosted darunavir antiretroviral regimen compared Gammora® arm) to a boosted darunavir antiretroviral regimen only (control arm) in the estimated HIV reservoir among antiretroviral naïve people living with HIV. The main questions it aims to answer are:
- Will the proviral (total) HIV-1 DNA decrease rapidly in the Gammora® arm compared to the control arm?
- Will the apoptosis markers evaluated in the CD4+ T cell by flow cytometry increase in the Gammora® arm compared to the control arm? Forty antiretroviral naïve viremic people with HIV with CD4+ T cell counts >350 cells/mL will be randomized to receive 20 mg of Gammora® in 2mL SC solution plus Tenofovir/3TC and Darunavir 800mg+Ritonavir 100mg (Gammora® arm) or antiretroviral only (control arm). In the Gammora® arm, participants had a 2-week Gammora® monotherapy lead-in period with Gammora® given daily before antiretroviral treatment is started, followed by 12 weeks of antiretroviral therapy plus Gammora® given every other day. The first two weeks of the trial (lead-in period for the Gammora® arm) were labeled w-2 and w-1 for both groups, and blood samples were collected for both groups. w0 denotes the week ART was started in both arms.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Confirmed HIV infection;
- •Antiretroviral naive;
- •HIV Viral load > 1.000;
- •CD4+ T cell counts >350 cells/mm3;
- •Body weight > 50 Kg;
- •Signed informed consent form.
排除标准
- •BMI < 18.5 kg/m2 at screening;
- •Coinfection with HBV (HBsAg +) or HCV;
- •Any significant acute illness within one week before the first visit.
- •Use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within four weeks before screening;
- •Active malignancy or malignancy in follow-up.
- •Changes in safety tests: neutrophil count < 1,000 u/L; Hb < 9.0 gm/dl; platelet count < 75,000 u/L; creatinine > 1.5 mg/dl, direct bilirubin > 85 μmol/L, AST or ALT > 2.5 X UNL;
- •Potential allergy or hypersensitivity to the components of the Gammora® formulation.
- •Participation in another clinical trial within 12 months before screening.
- •Any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the investigator's discretion.
研究组 & 干预措施
Gammora® arm
16-mer HIV integrase-derived peptide associated with Tenofovir/3TC + boosted darunavir antiretroviral regimen
干预措施: Gammora® (Drug)
结局指标
主要结局
Total Proviral HIV DNA quantitation
时间窗: Weekly from time of randomization for 27 consecutive weeks
Total HIV DNA measured by qPCR
Episomal Proviral HIV DNA quantitation
时间窗: Weekly from time of randomization for 27 consecutive weeks
Episomal HIV DNA measured by qPCR
Apoptosis markers
时间窗: Three times per week during from randomization to week 3 and weekly from that point through week 27
Evaluated by flow cytometry exclusively in the CD4+ T cell gates, using the PE Annexin V Apoptosis Detection kit (BD Biosciences)
次要结局
- HIV Viral load(Weekly from time of randomization for 27 consecutive weeks)
- CD4 T cell counts(Weekly from time of randomization for 27 consecutive weeks)
- CD8 T cell counts(Weekly from time of randomization for 27 consecutive weeks)
- Levels of Lymphocyte T Cell activation markers (CD38 and HLA-DR in CD4 and CD8+ T cells) for each participant(Weekly for 12 weeks and every 4 weeks after that)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Weekly for 12 weeks and every 4 weeks after that)
研究者
Ricardo Sobhie Diaz
Professor
Federal University of São Paulo