A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 10
研究概览
简要总结
PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3.
SECONDARY: To determine whether significant advantages to any one vaccine exist.
Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.
详细描述
Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.
Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concurrent Medication:
- •Short-term nonsteroidal anti-inflammatory therapy.
- •Patients must have:
- •HIV seropositivity.
- •CD4 count >= 500 cells/mm
- •Successful establishment of EBV-transformed B-cell lines at study entry.
- •Consent of parent or guardian if < 18 years of age.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Suspected or known allergies to any vaccine components.
- •Medical contraindication.
- •Problem with compliance.
- •Concurrent Medication:
- •Antiretroviral therapy (e.g., AZT, ddI, or ddC).
- •Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin).
- •Parenteral therapies (including SC allergy sensitization).
- •Other investigational HIV drugs or therapies.
- •Prior Medication:
- •Any prior vaccinations against HIV.
- •Antiretroviral therapy (e.g., AZT, ddI, or ddC) within the past 6 months.
- •Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin) within the past 3 months.
- •Parenteral therapies (including SC allergy sensitization) within the past 3 months.
- •Other investigational HIV drugs or therapies within the past 3 months.