Immunological and virological effects of high dose intravenous immunoglobulin (IVIG) treatment added to antiretroviral therapy against HIV
- Conditions
- HIV
- Registration Number
- EUCTR2005-003422-26-SE
- Lead Sponsor
- Göteborg University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 5
1.HIV-1 infected
2.Man or woman, =18 years old
3.Ability to understand and provide written informed consent
4.HIV-treatment with 2NRTI + PI/r =3 years
5.HIV-RNA <20 copies/mL =2.5 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Pregnancy
2.Women of childbearing potential not practicing birth control during the study.
3.History of antiretroviral treatment failure
4.Risk factors for tromboembolic disease, i.e. Age >70 years, hypertonia, diabetes mellitus, history of vascular disease or trombosis, platelet dysfunction disorders, immobilisation, severe hypovolemia or diseases with hyperviscosity.
5.Side effects on previous IVIG-treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To address whether IVIG can decrease the latent HIV-DNA burden given during effective antiretroviral therapy;Secondary Objective: ;Primary end point(s): Decrease in HIV-DNA in PBMC
- Secondary Outcome Measures
Name Time Method