This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
  Purpose
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.

Condition Intervention Phase
HIV-1 Biological: HIV DNA Vaccine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Active Immunotherapy Against HIV During Highly Active Anti-retroviral Therapy Followed by Repeated Treatment Interruptions

Resource links provided by NLM:


Further study details as provided by Swedish Institute for Infectious Disease Control:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 12
Study Start Date: September 2006
Study Completion Date: December 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140139

Locations
Sweden
South Hospital
Stockholm, Sweden, 1188
Sponsors and Collaborators
Swedish Institute for Infectious Disease Control
European Union
The Swedish Research Council
Läkare mot AIDS Forskningsfond
  More Information

Responsible Party: Professor Eric Sandström, Karolinska Institute and South Hospital, Stockholm
ClinicalTrials.gov Identifier: NCT01140139     History of Changes
Other Study ID Numbers: DermHIVImm
Study First Received: June 7, 2010
Last Updated: June 8, 2010

Additional relevant MeSH terms:
Vaccines
Hydroxyurea
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 21, 2017