Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions (Vac09)

This study has been completed.
Sponsor:
Collaborators:
European Union
The Swedish Research Council
Läkare mot AIDS Forskningsfond
Information provided by:
Swedish Institute for Infectious Disease Control
ClinicalTrials.gov Identifier:
NCT01140139
First received: June 7, 2010
Last updated: June 8, 2010
Last verified: February 2006

June 7, 2010
June 8, 2010
September 2006
October 2009   (final data collection date for primary outcome measure)
Safety and feasibility [ Designated as safety issue: Yes ]
The safety and feasibility of dermal HIV-1 DNA vaccination will be evaluated by recording all medical events. They will be graded as to their seriousness, severity and relationship to the immunization. Plasma HIV-1 RNA levels and T-cell levels will be closely monitored. In addition to this the patient's individual experience and quality of life will be assessed.
Same as current
Complete list of historical versions of study NCT01140139 on ClinicalTrials.gov Archive Site
Treatment effects [ Designated as safety issue: No ]
To evaluate whether dermal HIV-1 DNA vaccination can prolong periods without treatment in HIV-infected individuals. This will be evaluated by structured treatment interruption with close monitoring of HIV viral load and CD4+ T cell counts
Same as current
Not Provided
Not Provided
 
Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions
Active Immunotherapy Against HIV During Highly Active Anti-retroviral Therapy Followed by Repeated Treatment Interruptions

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 plasmids used in this study encode for envelope gp160 of HIV-1 subtypes A, B and C, rev B, Gag A and B and reverse transcriptase (RT) B. The patients were randomly assigned to three groups; group 1 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically, group 2 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically and treated with 500 mg of hydroxyurea daily until visit 10, group 3 (n=4) four patients received placebo. The immunization was performed during three cycles of 7 weeks of cART followed by four weeks of therapy interruption. After the last cycle of cART the patients were maintained on a definitive treatment interruption until CD4+ T cell counts dropped below 350/ mm3 at two time points. Cellular and humoral immune responses, viral load and CD4+ T a cell count was analysed throughout the study.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV-1
Biological: HIV DNA Vaccine
0.4 mg of DNA plasmids encoding HIV env A, B, C and Rev B, gag A, B and RT mut formulated in PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART. Every immunization cycle was followed by four weeks of therapy interruption.
  • Experimental: HIV DNA + Hydroxyurea
    0.4 mg of DNA plasmids encoding HIV env A, B, C and Rev B, gag A, B and RT mut formulated in PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART. Every immunization cycle was followed by four weeks of therapy interruption. The patients also received 500 mg of hydroxyurea daily.
    Intervention: Biological: HIV DNA Vaccine
  • Experimental: HIV DNA
    0.4 mg of DNA plasmids encoding HIV env A, B, C and Rev B, gag A, B and RT mut formulated in PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART. Every immunization cycle was followed by four weeks of therapy interruption.
    Intervention: Biological: HIV DNA Vaccine
  • Placebo Comparator: Placebo
    PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART. Every immunization cycle was followed by four weeks of therapy interruption.
    Intervention: Biological: HIV DNA Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with ongoing infection(s) other than HIV.
  2. Prior or current pancreatitis or history of alcohol abuse.
  3. Ongoing neuropathy and history of more than grade 1 neuropathy.
  4. History of mutations to more than one class of anti-retroviral drugs or switched drugs more than once due to failure.
  5. Sun or solarium exposure at the immunizing sites one month before or during the trial.
  6. Cortisone treatment, systemic or local at the immunizing sites, one month before or during the trial.
  7. Patients with signs of autoimmune diseases
  8. Patients with creatinine > 2mg/dl, Hb < 12g/dl, leukocytes < 3,000ul, platelets <150,000/ul and LFT > 5x upper limit of normal
  9. Patients on any immune modulating or investigational drug
  10. Anamnestic allergy to kanamycin, plasmid gene products
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01140139
DermHIVImm
Yes
Professor Eric Sandström, Karolinska Institute and South Hospital, Stockholm
Swedish Institute for Infectious Disease Control
  • European Union
  • The Swedish Research Council
  • Läkare mot AIDS Forskningsfond
Not Provided
Swedish Institute for Infectious Disease Control
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP