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

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ClinicalTrials.gov Identifier: NCT01140139
Recruitment Status : Completed
First Posted : June 9, 2010
Last Update Posted : June 9, 2010
Sponsor:
Collaborators:
European Union
The Swedish Research Council
Läkare mot AIDS Forskningsfond
Information provided by:
Swedish Institute for Infectious Disease Control

Tracking Information
First Submitted Date  ICMJE June 7, 2010
First Posted Date  ICMJE June 9, 2010
Last Update Posted Date June 9, 2010
Study Start Date  ICMJE September 2006
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2010)
Safety and feasibility
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2010)
Treatment effects
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions
Official Title  ICMJE Active Immunotherapy Against HIV During Highly Active Anti-retroviral Therapy Followed by Repeated Treatment Interruptions
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HIV-1
Intervention  ICMJE 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.
Study Arms
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2010)
12
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date December 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01140139
Other Study ID Numbers  ICMJE DermHIVImm
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Professor Eric Sandström, Karolinska Institute and South Hospital, Stockholm
Study Sponsor  ICMJE Swedish Institute for Infectious Disease Control
Collaborators  ICMJE
  • European Union
  • The Swedish Research Council
  • Läkare mot AIDS Forskningsfond
Investigators  ICMJE Not Provided
PRS Account Swedish Institute for Infectious Disease Control
Verification Date February 2006

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