Treatment of HIV infection
Conditions
Interventions
Product Name: HIVIS DNA
Product Code: HIVIS DNA
Pharmaceutical Form: Cutaneous solution
Pharmaceutical form of the placebo: Cutaneous solution
Route of administration of the placebo: Cutaneous use
Sponsors
Swedish Institute for Infectious Disease Control
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 5x upper limit of normal 10. Patients on any immune modulating or investigational drug 11. Anamnestic allergy to kanamycin, plasmid gene products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To document the safety and feasibility of topical plasmid DNA immunization 2. To investigate if topical immunization with DNA plasmids carrying HIV genes during cycles of effective HAART can reduce the viral load when HAART is interrupted. 3. To study the effect on CD4 counts i the three groups ;Secondary Objective: 1. To correlate the viral load after the third STI to immune responses at that time 2. To investigate if hydroxyurea increases the efficacy of topical immunization. 3. To characterize the new HIV specific immune responses by Elispot and other single cell methods 4. To investigate the possible viral escape mutants in relation to the induced immune responses 5. To study the individual experience and quality of life of the patients during repeated cycles of STIs combined with immunizations ;Primary end point(s): 1. Grade 3 or above toxicity possibly or probably related to the immunization or hydroxyurea. 2. Viral load at week 33 compared between groups or with baseline. 3. CD4 slope between groups or optionally time to reach CD4 of 350 | — |
Countries
Sweden
Outcome results
None listed