Status:
COMPLETED
Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions
Lead Sponsor:
Swedish Institute for Infectious Disease Control
Collaborating Sponsors:
European Union
The Swedish Research Council
Conditions:
HIV-1
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
In this study, the investigators evaluated a therapeutic HIV-1 DNA vaccine administered with a novel topical application method to 12 chronically HIV-infected cART treated patients. The HIV DNA plasmi...
Eligibility Criteria
Inclusion
- Aged between 18 and 60 years
- Female, who is documented infertile or in menopause since at least 1 year, or male, who are willing not father a child for the duration of the study.
- HIV infection detected by two serological and/or HIV plasma RNA tests
- On HAART for at least 6 months with less than 50 copies/ml of plasma HIV-1 RNA at two determinations over 3 months
- Current CD4 count above 400
- CD4 count nadir \>200
- Viral isolate pre ART available is preferable but not mandatory
- Willing to consider stopping HAART repeatedly.
- Willing to conform to a low alcohol intake (maximum of one glass per day)
- Able to tolerate didanosine and hydroxyurea
- Willing to change their HAART to exclude NNRTI and stavudine
- Able to give informed consent
- Availability for follow-up for planned duration of the study
Exclusion
- Patients with ongoing infection(s) other than HIV.
- Prior or current pancreatitis or history of alcohol abuse.
- Ongoing neuropathy and history of more than grade 1 neuropathy.
- History of mutations to more than one class of anti-retroviral drugs or switched drugs more than once due to failure.
- Sun or solarium exposure at the immunizing sites one month before or during the trial.
- Cortisone treatment, systemic or local at the immunizing sites, one month before or during the trial.
- Patients with signs of autoimmune diseases
- Patients with creatinine \> 2mg/dl, Hb \< 12g/dl, leukocytes \< 3,000ul, platelets \<150,000/ul and LFT \> 5x upper limit of normal
- Patients on any immune modulating or investigational drug
- Anamnestic allergy to kanamycin, plasmid gene products
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01140139
Start Date
September 1 2006
End Date
December 1 2009
Last Update
June 9 2010
Active Locations (1)
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1
South Hospital
Stockholm, Sweden, 1188