NL-OMON31815撤回2 期
A phase II, double blind randomized study to evaluate the efficacy of the therapeutic HIV-1 vaccine NYVAC-B versus placebo in chronic HIV-1 infected patients successfully treated with HAART (TheraVac-03) - TheraVac-03
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient is >= 18 years of age;
- •2. Voluntarily signed informed consent;
- •3. Patient is male, or female with negative pregnancy test prior to enrolment;
- •4. Patient has a proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA, measured for the first time at least 6 months prior to inclusion);
- •5. Patient must be on stable treatment with HAART for at least 6 months (HAART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents*; changes within the same class of drugs only for toxicity or simplification reasons are allowed, at least 3 months for inclusion);
- •6. Mean of all measured CD4+ T cell counts during the 6 months prior to the start of HAART is above or equal to 200 cells/ mm3;
- •7. Plasma HIV-1 RNA must be below 50 copies/ mL at screening and during at least 3 months prior to inclusion, during at least two measurements (occasional so called *blips* up to 200 copies/mL are permitted, but not at screening),
- •8. HIV-1 subtype is proven to be clade B; if subtype is unknown, subtype should determined in stored samples with detectable plasma HIV-1 OR in HIV-1 DNA isolated from PBMCs at screening;
- •9. Patient is one of the following:
- •- the patient is a heterosexually active female, agreeing to use condoms with her partner from 14 days prior to the first vaccination until 4 months after the last, even though using another method of contraception, and willing to undergo pregnancy tests at screening and prior to each vaccination, OR
- •- the patient is male and agreeing to use condoms with his partner from the day of the first vaccination until 4 months after the last vaccination, OR
- •- none of these apply.
排除标准
- •1. History of a CDC class C event (see Appendix I, page 46);
- •2. Infection with a non-B HIV-1 subtype;
- •3. Interruption of HAART during the course of the study which is expected at the time of inclusion;
- •4. History of exposure < 20 years ago to any poxvirus based vaccine;
- •5. Previous exposure to any HIV experimental vaccine;
- •6. Patient is female and is breast-feeding or has a positive pregnancy test or the wish of pregnancy;
- •7. Any active infection or any serious disease such as cancer, hepatitis, severe liver, renal or cardiovascular diseases or dysfunctions;
- •8. Current or previous antiretroviral treatment with CCR5-blockers (i.e. maraviroc), integrase inhibitors (i.e. raltegravir) or etravirine (TMC125);
- •9. Therapy with immunomodulatory agents, including cytokines (e.g. IL2) and gamma globulin, or cytostatic chemotherapy within 90 days prior to screening visit;
- •10. History of egg-allergy;
- •11. Use of anti-coagulant medication;
- •12. Use of any investigational drug or vaccine during the 90 days prior to study entry;
- •13. Patient received a *live* attenuated vaccine within the last 30 days;
- •14. Any other condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
研究者
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