Active immunotherapy against HIV during highly active anti-retroviral therapy followed by repeated treatment interruptions, VAC 09. - Vac 09

• Conditions: Treatment of HIV infection

• Registration Number: EUCTR2005-002849-40-SE
• Lead Sponsor: Swedish Institute for Infectious Disease Control

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-09
• Last Update Posted: 29 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Aged between 18 and 60 years
2.HIV infection detected by two serological and/or HIV plasma RNA tests
3.On HAART for at least 6 months with less than 50 copies/ml of plasma HIV-1 RNA at two determinations over 3 months
4.Current CD4 count above 400
5.CD4 count nadir >200
6.Viral isolate pre ART available is a preferable but not mandatory
7.Willing to consider stopping HAART repeatedly.
8.Willing to conform to a low alcohol intake (maximum of one glas per day)
9.Able to tolerate didanosine and hydroxyurea
10. Willing to change their HAART to exclude NNRTI and stavudine
11.Able to give informed consent
12.Availability for follow-up for planned duration of the study

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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnancy
2.Patients with ongoing infection(s) other than HIV.
3.Prior or current panceatitis or history of alcohol abuse.
4.Ongoing neuropathy and history of more than grade 1 neuropathy.
5.History of mutations to more than one class of anti-retroviral drugs or switched drugs more than once due to failure.
6.Sun or solarium exposure at the immunizing sites one month before or during the trial.
7.Cortisone treatment, systemic or local at the immunizing sites, one month beforte or during the trial.
8.Patients with signs of autoimmune diseases
9.Patients with creatinine > 2mg/dl, Hb < 12g/dl, leukocytes < 3,000ml, platelets <150,000/ml and LFT > 5x upper limit of normal
10.Patients on any immune modulating or investigational drug
11.Anamnestic allergy to kanamycin, plasmid gene products

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified