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)
- Conditions
- HIVHIV-1 infection10047438
- Registration Number
- NL-OMON31815
- Lead Sponsor
- EuroVacc Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 15
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint (outcome measure) is the difference in plasma HIV-1 RNA<br /><br>between the study arms during the 28 weeks after the first vaccination. </p><br>
- Secondary Outcome Measures
Name Time Method