- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01140139
Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions (Vac09)
8. juni 2010 opdateret af: Swedish Institute for Infectious Disease Control
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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Stockholm, Sverige, 1188
- South Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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 Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
|
Eksperimentel: 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.
|
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 komparator: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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Safety and feasibility
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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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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Treatment effects
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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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2006
Primær færdiggørelse (Faktiske)
1. oktober 2009
Studieafslutning (Faktiske)
1. december 2009
Datoer for studieregistrering
Først indsendt
7. juni 2010
Først indsendt, der opfyldte QC-kriterier
8. juni 2010
Først opslået (Skøn)
9. juni 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. juni 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2010
Sidst verificeret
1. februar 2006
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- DermHIVImm
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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