HIV-1infected patients MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection
Conditions
Interventions
Product Name: LC002 DermaVir Patch
Pharmaceutical Form: Cutaneous solution
Current Sponsor code: LC002 DermaVir
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Pharmaceutical form
Sponsors
VIROSTATICS, SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HIV-1-infected adults; Age: ≥18 years and 250 cells/mm3 Pre-HAART viral load > 5,000 copies/mL At least two viral load and two CD4 measurement for determination of nadir prior to HAART initiation Undetectable viral load (i.e., three or more determinations of 500 cells/mm3 for the six month period preceding the study Patient willing to comply with study regimen/Analytical Treatment Interruption Female study volunteers who are participating in sexual activity that could lead to pregnancy must agree to not become pregnant and use two methods of contraception, including at least one form of barrier contraception, while receiving DermaVir/Placebo and for 6 months after the last administration. Medically acceptable contraceptives include: Approved hormonal contraceptives, such as birth control pills, Depo-Provera, or Lupron Depot Barrier methods (such as condom or diaphragm) used with a spermicide Consult the CDC guidelines on the use of spermicide in this population Condoms are recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission. An intrauterine device (IUD) Sexually active female study volunteers without reproductive potential are eligible without requiring the use of contraception. Written or oral documentation communicated by clinician or clinician?s staff of one of the following is required for participants: physician report/letter, discharge summary. All male subjects 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 while receiving DermaVir/Placebo and for 6 months after the last administration. Patient willing to comply with study regimen. Patient 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Skin disease such as: active atopic dermatitis active or history of psoriasis active urticaria Known hypersensitivity to adhesive tape or Tegaderm History of keloid (hypertrophic scar) at the skin treatment sites Active or history of vitiligo Melasma (acquired hyperpigmentation disorder) Skin cancer, including: Basal cell carcinoma Squamous cell carcinoma Melanoma Kaposi?s sarcoma Tattoos or changes in pigment at the skin treatment sites Active acute or chronic immune-compromising illness, including but not limited to: diagnosis of any chronic autoimmune disease clinically significant bleeding disorder diabetes mellitus requiring insulin and/or drug therapy Hepatitis B Antigen S at baseline Detectable hepatitis C RNA at baseline Treatment with any immune modulating agents or chemotherapy within 12 months prior to study Receipt of any immune globulin or blood products within three months prior to study Any vaccination within 28 days of study initiation Anticipation of any vaccination during the of the study Any interruption in HAART of > 7 consecutive days within 1 year of study entry History of lymph node irradiation Any malignancy within 12 months prior to screening Systemic steroid therapy within the past two months Pregnancy or Breast-feeding Values greater than or equal to Grade 2 in the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (Version 1.0 [December 2004], http://rcc.tech-res-intl.com) for any of the following laboratory tests at screening will be excluded [Grade 2 value and standard international units in italics] Hemoglobin (Hgb) [≤8.4 g/dL] Absolute neutrophil count (ANC) [≤999/mm3, ≤0.999 x 109/L] Platelets, decreased [≤99,999/mm3, ≤99.999 x 109/L] Liver Function Tests (LFTs)-ALT (SGPT)/AST (SGOT) [≥2.6 x ULN] Creatinine [≥1.4 x ULN]-use age and sex appropriate values (per DAIDS Table) Lipase and pancreatic amylase [≥1.6 x ULN] Total bilirubin [≥1.6 x ULN]. NOTE: Subjects with total bilirubin ≥ 1.6 x ULN, receiving Indinavir and/or Atazanavir with an Alkaline Phosphatase less than or equal to 1.0 x ULN are eligible. Excessive exposure to the sun (sunbathing, tanning beds) or any type of hair removal, tattoo removal, etc. at or in close proximity to the treatment site (patch areas) within 14 days prior to study entry. Close proximity is defined as: within 2 cm (about Ÿ of an inch) of the treatment site or close enough to the treatment site that an overlap cannot be ruled out. Any condition or history of illness, including drug or alcohol abuse that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether HIV PHPC counts measured at week 9 during maximally suppressive HAART in HIV+ adults is higher in subjects receiving DermaVir Patches treatment than in Placebo subjects;Secondary Objective: To determine whether subjects on fully-suppressive HAART who develop increases in HIV-specific PHPC have lower HIV-1 RNA during ATI (defined as the geometric mean of HIV-1 RNA obtained at Week 16and Week 20) than subjects who do not increase PHPC To investigate whether HIV-specific PHPC counts measured during maximally suppressive HAART correlate with a lower Viral Load Time Averaged Area Under the Curve (TA-AUC) during ATI To determine if subjects who experience an increase in PHPC Gag p17 counts &#8805; 2,000 and/or PHPC total Gag counts &#8805; 5,000 prior to ATI are more likely to maintain HIV-1 RNA levels a.) below 400 copies/mL b.) below 5,000 copies/mL c.) lower than prior to HAART treatment at 16 and 20 weeks of an ATI than subjects who have PHPC Gag p17 counts < 2,000 and/or PHPC total Gag counts < 5,000 prior to ATI;Primary end point(s): PHPC counts at study Week 9 during HAART | — |
Countries
Italy
Outcome results
None listed