A PHASE II, RANDOMIZED, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND ANTIRETROVIRAL ACTIVITY OF DERMAVIR (LC002) PATCH IN TREATMENT-NAÏVE HIV-1-INFECTED PATIENTS

• Conditions: Treatment Naive HIV-1 infected patients; MedDRA version: 9.1Level: LLTClassification code 10020180Term: HIV positive

• Registration Number: EUCTR2007-001955-20-DE
• Lead Sponsor: Genetic Immunity Kft.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

10.1.1 Age: =18 and =50 years.
10.1.2 Chronic HIV infection, for the purpose of the study defined as:
confirmed time point of seroconversion for HIV antibodies at least 6
months before study entry and no signs of symptomatic acute HIV
infection in the 12 months before study entry.
10.1.3 Plasma HIV RNA value =5,000 copies/mL and = 150,000 c/mL.
10.1.4 Patients must be antiretroviral therapy naïve
10.1.5 Documented CD4+ T-cell count at screening =400 cells/mm3.
10.1.6 Female study volunteers who are participating in sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception, one of which must be a barrier method. A barrier method of contraception (condoms or cervical cap) together with another reliable form of contraception (condoms, with a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormonal-based contraception) must be used while receiving vaccine and for 6 weeks after stopping the vaccine. Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission. Sexually active female study volunteers without reproductive potential are eligible without requiring the use of contraception. Written documentation of missing reproductive potential needs to be confirmed by study investigator before vaccination.
10.1.7 Male patients participating in the study must agree to not attempt to impregnate a female, or participate in sperm donation programs. Males engaging in sexual activity that could lead to pregnancy must use a condom from the date of receipt of the first study vaccine until six weeks after receipt of the last study vaccine. This needs to be documented in written form by study investigator and patient before vaccination.
10.1.8 Patient must be able and willing to provide signed informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

10.2.1 Clinically relevant skin disease as determined by the investigator, such as:
• Active atopic dermatitis
• Active or history of psoriasis
• Active urticaria
• Known hypersensitivity to adhesive tape or Tegaderm®
• History of keloid
• Active or history of vitiligo
• Melasma (acquired hyperpigmentation disorder)
• Acute or chronic skin infections or history of recurrent skin infections
10.2.2 Patients with tattoos, or changes in pigmentation at the selected skin immunization sites, will be excluded, if the study investigator decides this would have an impact on the study.
10.2.3 Active acute or chronic illness (e.g Hepatitis C) that is in the opinion of the investigator clinically relevant and a contra-indication for enrollment in the study including active severe clinical HIV disease complications (all CDC clinical Category C complications, see Appendix III).
10.2.4 Diagnosis of any chronic autoimmune diseases (e.g. Grave’s) or bleeding disorder that is in the opinion of the investigator clinically relevant and a contra-indication for enrollment in the study or insulin dependent diabetes mellitus.
10.2.5 Greater than or equal to Grade 2 values for any of the following laboratory tests at screening, will be excluded [standard international units in italics].
• Hemoglobin (Hgb) [less than or equal to 8.4 g/dL (less than or equal to 5.2 mmol/dl)]
• Absolute neutrophil count (ANC) [less than or equal to 999/mm3, =0.999 x 109/L]
• Platelets, decreased [less than or equal to 99,999/mm3, =99.999 x 109/L]
• Liver Function Tests (LFTs) ALT (SGPT)/AST (SGOT) [greater than or equal to 2.5 times the upper limit of normal (ULN)]
• Creatinine [greater than or equal to 1.5 x ULN]-use age and sex appropriate values (per DAIDS Table)
• Total bilirubin [greater than or equal to 2.0 x ULN]
• Any other clinical and laboratory toxicity (=Grade 2) that is in the opinion of the investigator clinically relevant and a contra-indication for enrollment in the study.
10.2.6 Prior treatment with any HIV vaccine.
10.2.7 Treatment with any immune modulating agents (e.g. IL-2, IFN-?, GM-CSF) or chemotherapy for malignancy within 12 months prior to screening.
10.2.8 Receipt of any immunizations or vaccinations within 28 days of entry into this study.
10.2.9 Systemic steroid therapy within the past 28 days.
10.2.10 Breast-feeding.
10.2.11 Pregnancy.
10.2.12 Excessive exposure to the sun (sunbathing, tanning beds) or laser hair removal/tattoo removal etc. at or near the vaccine site within 2 weeks prior to study entry.
10.2.13 Participation in any clinical trial of an experimental drug or device in the previous 30 days
10.2.14 Patients with malignancy within 12 month prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified