DermaVir Patch (LC002) in HIV-1 Infected Patients Currently on HAART - Full Text View

Sponsored by:	Genetic Immunity
Information provided by:	Genetic Immunity
ClinicalTrials.gov Identifier:	NCT00712530

Purpose

GIHU004, a phase I sequential dose escalation cohort study is designed to evaluate the safety and immunogenicity of three dosing regimens of LC002 for the treatment of individuals with chronic HIV-1 infection who have highly active antiretroviral therapy (HAART)-induced durable suppression of viral replication. Subjects will be assigned to one of three cohorts. Subjects in cohort 1 will be randomized to receive one low-dose LC002 vaccination (3 subjects). Further enrollment of subjects into the medium dose cohort 2 (3 subjects) and high dose cohort 3 (3 subjects) will begin only after the safety data for cohort 1 and 2, respectively, are available, and the criteria for enrolling the next cohort are met. The main criterion to advance to the next cohort will be the absence of a dose-limiting toxicity.

Condition	Intervention	Phase
HIV Infections	Biological: DermaVir Patch	Phase I

MedlinePlus related topics: AIDS AIDS Medicines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	A Phase I Study to Evaluate the Tolerability and Safety of LC002, a DermaVir Vaccine, in HIV-1-Infected Subjects Currently Under Treatment With Highly Active Antiretroviral Therapy (HAART)

Further study details as provided by Genetic Immunity:

Primary Outcome Measures:

Safety: local and systemic toxicity was evaluated using the ACTG standard adverse event reporting system [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity of DermaVir Patch [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Anti-DNA antibody response after immunization [ Time Frame: Before and after immunization ] [ Designated as safety issue: Yes ]
To explore whether there are differences in the tolerability of LC002 with respect to pre-mature treatment discontinuation between treatment arms [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
To explore if immunization results in any changes in viral load [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment:	9
Study Start Date:	January 2005
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Low dose active patch	Biological: DermaVir Patch Low dose DermaVir Patch, two patches
2: Active Comparator Medium dose active patch	Biological: DermaVir Patch Medium dose DermaVir Patch, four patches
3: Active Comparator High dose active patch	Biological: DermaVir Patch High dose DermaVir Patch, eight patches

Detailed Description:

This phase I trial is designed to evaluate the safety and immunogenicity of LC002 for the treatment of individuals with chronic HIV-1 infection and HAART-induced durable suppression of viral replication. The study population will include HIV-infected men and women 18 to 50 years of age with a peak plasma HIV-1 RNA > 1000 copies/mL before initiation of HAART. Eligible subjects must have been and remain on a stable HAART regimen (containing drugs of at least two different classes) without changes or interruptions within the 12 weeks prior to study entry and must have a plasma HIV-1 RNA level < 50 copies/mL at least twice within 12 weeks prior to study entry. Subjects should have a CD4+ cell count > 300 cells/mm3 at the time of entry and a nadir CD4+ cell count > 250 cells/mm3.

Subjects in cohort 1 will be enrolled to receive one low-dose DermaVir vaccinations (3 subjects). Further enrollment of subjects into the medium and high dose cohorts 2 and 3 (3 subjects, respectively) will begin only after the safety data for cohorts 1 and 2, respectively, are available, and the criteria for enrolling into the next cohort are met. The main criterion to start enrolling the next dose cohort will be the absence of a dose-limiting toxicity in any of the DermaVir subjects in the prior cohort. The actual immunization will be administered once, and after the four-week treatment phase and evaluations, subjects will be followed for an additional 48 weeks for safety.

Subjects will be sequentially enrolled into each cohort:

• Cohort 1: Three subjects will receive a single low-dose vaccination (0.1 mg DNA/subject, 0.8 mL total, administered over two skin sites of 80 cm2 each, 0.4 mL/site) at study day 0.

• Cohort 2: Three subjects will receive a medium-dose vaccination (0.4 mg DNA/subject, 3.2 mL total, administered over four skin sites of 80 cm2 each, 0.8 mL/site) at study day 0

• Cohort 3: Three subjects will receive a high-dose vaccination (0.8 mg DNA/subject, 6.4 mL total, administered over eight skin sites of 80 cm2 each, 1.6 mL/site) at study day 0.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability and willingness of subject or legal guardian/representative to give written informed consent
HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA
On a stable antiretroviral regimen without changes or interruptions for at least 12 weeks prior to study entry
Plasma HIV-1 RNA level of less than 50 copies/mL, obtained at least twice within the 12 weeks prior to study entry
Peak plasma HIV-1 RNA level before initiation of HAART > 1000 copies/mL
CD4 cell count > 300 cells/mm3 within the 12 weeks prior to study entry
Nadir (lowest) CD4+ cell count > 250 cells/mm3 at any time prior to study entry
The following laboratory values, obtained within 30 days prior to study entry:
- Absolute neutrophil count (ANC) > 1000/mm3
- Hemoglobin > 9.0 g/dL
- Platelet count > 50,000/mm3
- Serum creatinine < upper limit of the laboratory normal range (ULN)
- AST (SGOT), ALT (SGPT), and alkaline phosphatase < 2.5 x ULN
- Total bilirubin < 2.5 x ULN
- Anti-nuclear antibody (ANA) titer of 1:40 or lower and negative for serum anti-double-stranded DNA antibody (anti-ds-DNA) test result at screening.
All women of reproductive potential must have a negative urine beta-HCG pregnancy test performed within 14 days prior to study entry.
Female study volunteers who are not of reproductive potential or whose male partner has undergone successful vasectomy are eligible without requiring the use of contraception. Acceptable documentation of menopause, sterilization, and azoospermia is written or oral documentation communicated by clinician.
All subjects must not participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) and, if participating in sexual activity that could lead to pregnancy, the study volunteer/ partner must use two reliable methods of contraception simultaneously while receiving the protocol-specified vaccination and for 3 months after the last vaccination.
Karnofsky performance score > 90 within 30 days prior to study entry
Men and women age 18-50 years

Exclusion Criteria:

Viral load measurement > 50 copies/mL within the last 12 weeks prior to study entry
History of or evidence of active skin disease (e.g. atopic dermatitis), chronic autoimmune disease or any other significant active skin disease
Treatment with topical corticosteroids in close proximity to the proposed vaccination sites within 2 weeks prior to study entry
Excessive exposure to the sun (e.g. sunbathing) within 2 weeks prior to study entry
Use of any local skin treatments to the targeted vaccination sites within 7 days prior to study entry
History of diabetes and bleeding disorders
Previous CDC category C event
Pregnancy or breast-feeding
Use of immunomodulating therapy, including cyclosporin, IgG-containing products, interleukins, interferons, systemic glucocorticosteroids, or exposure to an experimental HIV vaccine within 6 months prior to study entry
Receipt of any vaccine within 30 days prior to study entry
Allergy/sensitivity to study vaccine products, including adhesives, will be excluded
Active drug or alcohol use or dependence
Serious illness until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry
Hepatitis B surface antigen and/or anti-hepatitis C positive

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712530

Locations

Hungary
Saint Laszlo Hospital
Budapest, Hungary, 1097

Sponsors and Collaborators

Genetic Immunity

Investigators

Principal Investigator:

Denes Banhegyi, MD

Saint Laszlo Hospital

More Information

Genetic Immunity's homepage This link exits the ClinicalTrials.gov site

Responsible Party:	Genetic Immunity Kft. ( Julianna Lisziewicz, PhD )
Study ID Numbers:	GIHU004
Study First Received:	July 4, 2008
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00712530
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by Genetic Immunity:

HIV
Vaccine
Immune Therapy
DermaVir

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009