A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 34
研究概览
简要总结
To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1 month to 18 years of age.
The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease.
详细描述
The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease.
Patients are randomized to receive one of three vaccines (9 patients/vaccine) or the adjuvant placebos (3 patients/vaccine). The vaccines will be studied at both low and high doses. When three of four patients at the low dose of a vaccine have received two immunizations without evidence of dose-limiting toxicity, dose escalation to the higher dose of that vaccine is initiated in subsequent patient cohorts, provided all low dose arms are filled. A total of six immunizations are given, at 0, 4, 8, 12, 16, and 24 weeks. Patients are followed for 24 weeks after the last immunization.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication: Recommended:
- •PCP prophylaxis.
- •Patients must have:
- •Documented asymptomatic HIV infection.
- •CD4+ count as follows:
- •1-11 months of age must have > 2000 cells/mm3 and >= 30 percent of the total lymphocytes; 12-23 months must have > 1000 cells/mm3 and >= 20 percent of the total lymphocytes; 24 months-6 years must have > 750 cells/mm3 and >= 20 percent of the total lymphocytes; and 7 years and older must have > 500 cells/mm3 and >= 20 percent of the total lymphocytes.
- •Patients who received zidovudine for 3 consecutive months immediately prior to study entry may receive only high doses of vaccine.
排除标准
- •Co-existing Condition:
- •Patients with the following condition are excluded:
- •Any serious acute infection.
- •Concurrent Medication:
- •Anticipated steroid therapy of > 6 weeks duration.
- •Excluded within the past 2 years:
- •More than one serious proven bacterial infection such as sepsis, pneumonia, meningitis, bone or joint infection, abscess of an internal organ or body cavity (other than otitis media or superficial skin or mucosal abscesses) caused by Haemophilus, Streptococcus, Pneumococcus, or other pyogenic bacteria.
- •Prior Medication:
- •Antiretroviral therapy or immunomodulators (e.g., IVIG) within 1 month prior to study entry (NOTE: AZT is allowed within 1 month prior to study entry if patient is entering a high-dose arm).
- •Uninterrupted steroid therapy of > 6 weeks duration.