Immunological and virological effects of high dose intravenous immunoglobulin (IVIG) treatment added to antiretroviral therapy against HIV

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003422-26-SE

Enrollment

Registered

2006-03-08

Start date

2006-08-04

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Interventions

Trade Name: Gammagard Product Name: immunoglobulin Product Code: immunoglobulin Pharmaceutical Form: Intravenous infusion Other descriptive name: immunoglobulin Trade Name: Ergenyl Product Name: Natr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026